[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"irritable-bowel-syndrome-ibs\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:irritable-bowel-syndrome-ibs":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,45,83,106,134,162,193,219,248,278,304,329,357,381,410,440,465,485,506,541,565,589,616,638,665],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100643677","efficacy-of-pregabalin-for-patients-with-irritable-bowel-syndrome-100643677",false,"NCT07635394","Efficacy of Pregabalin for Patients With Irritable Bowel Syndrome","Efficacy and Safety of Pregabalin in Patients With Irritable Bowel Syndrome : A Multi-center Prospective Randomized Open Blinded End-point Trial","Inclusion Criteria:\n\n1. Age range: 18-70 years old;\n2. According to the Rome IV diagnostic criteria for IBS, the screening result is positive;\n3. Mild to moderate IBS patients assessed based on the IBS-SSS.\n\nExclusion Criteria:\n\n1. Concurrent gastrointestinal conditions presenting with symptoms potentially overlapping with those of IBS, significant medical comorbidities;\n2. Severe mental disorders associated with marked personality disturbances, active suicidal thoughts or any self harm episodes within the preceding 12 months;\n3. Current or intended pregnancy or lactation;\n4. Cognitive impairment;\n5. Recent use of pregabalin (within 30 days) or known allergy to pregabalin;\n6. Concomitant use of medications that may interact with the study drug, mimic its effects, or aggravate expected adverse reactions (including but not limited to rosiglitazone, pioglitazone, opioids, anxiolytics, non opioid analgesics, mexiletine, dextromethorphan, and sedative hypnotics);\n7. Use of IBS specific agents such as alosetron;\n8. Consumption exceeding 50 units of alcohol weekly (where 1 unit corresponds to 10 mL of pure alcohol).","ALL","18 Years","70 Years",{"count":21,"type":22},258,"ESTIMATED","INTERVENTIONAL",[25],"NA","To explore the efficacy of pregabalin for patients with irritable bowel syndrome (IBS).",[28],"Irritable Bowel Syndrome (IBS)",[30,31],"Irritable Bowel Syndrome","pregabalin","RECRUITING","2026-06-23",{"date":35,"type":36},"2026-06-25","ACTUAL",{"date":38,"type":36},"2026-04-07",{"date":40,"type":22},"2029-03-31",{"name":42,"class":43},"Beijing Tiantan Hospital","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":52,"targetDuration":54,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":66,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":44},"100401388","indiana-university-gastrointestinal-motility-diagnosis-registry-100401388","NCT04506593","Indiana University Gastrointestinal Motility Diagnosis Registry","Gastrointestinal Motility Diagnosis Registry","Inclusion Criteria:\n\n1. Patients who presented to the GI outpatient clinics, in-patient consult service, and outpatient endoscopy centers within the Division of Gastroenterology and Hepatology\n2. Carries a diagnosis of GI motility disorder based on the diagnostic criteria listed in table\n\nExclusion Criteria:\n\n1\\. Coexisting medical conditions that may limiting participation in clinical research trial",{"count":53,"type":22},5000,"10 Years","OBSERVATIONAL","Develop a registry (list of patients) with accurate clinical motility diagnosis. This registry will help the doctors to identify the patients with specific disease conditions. It will also help in promoting future research in gastroenterology motility disorders",[58,59,60,61,28,62,63,64,65],"Eosinophilic Esophagitis","Gastroesophageal Reflux Disease (GERD)","Gastroparesis","Functional Vomiting","Constipation","Chronic Intestinal Pseudo-obstruction","Fecal Incontinence","Small Intestinal Bacterial Overgrowth",[67,68,69,70,71,72,73,60],"Eosinophilic esophagitis","Chronic intestinal pseudo-obstruction","Small Bowel dysmotility","SIBO","Vomiting","Functional dyspepsia","Functional bloating","2026-06-15",{"date":76,"type":36},"2026-06-16",{"date":78,"type":36},"2014-11-01",{"date":80,"type":22},"2026-11",{"name":82,"class":43},"Indiana University",{"id":84,"slug":85,"hasResults":12,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":17,"minAge":18,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":44},"100642960","anxiety-and-depression-in-ibs-a-brain-gut-axis-study-100642960","NCT07646834","Anxiety and Depression in IBS: A Brain-Gut Axis Study","Investigating the Brain-Gut Axis Regulatory Mechanism of Anxiety and Depression in Irritable Bowel Syndrome","Inclusion Criteria:\n\n1. Right-handed, aged 18-60 years, with more than 6 years of education;\n2. Meeting the Rome IV diagnostic criteria for IBS: Symptoms have been present for at least 6 months, and for the last 3 months, the following criteria are met: recurrent abdominal pain or discomfort, with symptoms occurring on at least 3 days per month in the last 3 months, associated with two or more of the following: 1) Improvement with defecation; 2) Onset associated with a change in frequency of stool; 3) Onset associated with a change in form (appearance) of stool;\n3. The following symptoms support the diagnosis of IBS: 1) Abnormal stool frequency: \\\u003C3 bowel movements per week or \\>3 bowel movements per day; 2) Abnormal stool form: lumpy\u002Fhard stool or mushy\u002Fwatery stool; 3) Straining during defecation; 4) Urgency or a feeling of incomplete evacuation; 5) Passage of mucus; 6) Bloating.\n\nExclusion Criteria:\n\n1. History of anti-anxiety\u002Fdepressant medication use (e.g., SSRI\u002FSNRI, Chinese patent medicines) within the past 1 month;\n2. History of antibiotic or probiotic use within the past 1 month;\n3. Other gastrointestinal diseases such as IBD, intestinal obstruction, or history of gastrointestinal surgery;\n4. Current or past history of psychiatric or neurological disorders, such as psychosis, brain tumors, or impaired consciousness;\n5. Concurrent severe hepatic or renal insufficiency, cardiovascular or cerebrovascular diseases, or malignant tumors; 7.0T MRI Contraindications: Presence of ferromagnetic implants (e.g., cardiac pacemakers, defibrillators, neurostimulators, aneurysm clips, cochlear implants, or any metallic foreign bodies); Non-ferromagnetic implants (e.g., titanium alloy, orthopedic implants), various types of intrauterine devices, various types of non-removable dentures (including dental implants); Presence of metallic foreign bodies (e.g., metal fragments, shrapnel, or filings in the eyes or body), such as in individuals engaged in welding work or with a history of metal item trauma; Tattoos or permanent makeup (e.g., eyebrows, lips) applied within the past month; Claustrophobia; Fever.\n\nHC Group Inclusion Criteria (all must be met):\n\n1. Right-handed, aged 18-60 years, with more than 6 years of education;\n2. All physiological indicators are within normal ranges, with no signs of disease;\n3. No family history of psychiatric or neurological disorders.",true,"60 Years",{"count":93,"type":22},200,"This study aims to understand how the gut and the brain communicate in people with Irritable Bowel Syndrome (IBS) who also experience anxiety and depression. We want to see if changes in gut bacteria are linked to changes in brain function, and to find potential markers that could help in diagnosis or future treatments.\n\nWe are looking for two groups of volunteers aged 18 to 60 years: 1) 100 patients diagnosed with IBS who also have symptoms of anxiety or depression, and 2) 100 healthy volunteers for comparison. All participants must be right-handed.\n\nParticipants in this observational study will not receive any new drug or treatment. Instead, they will be asked to:\n\nComplete questionnaires about their bowel symptoms, anxiety, depression, sleep, and thinking skills.\n\nProvide a stool sample (about 5 grams) and a blood sample (about 5 ml).\n\nUndergo a brain scan using a 7 Tesla MRI machine, which will take about 45-50 minutes. They will need to lie still during the scan.\n\nSome IBS patients may be invited for a follow-up visit after 3 months to repeat the questionnaires and sample collection.\n\nThere are minimal risks involved. The MRI scan is non-radioactive and considered very safe, but some people may feel uncomfortable or claustrophobic inside the machine. Giving blood may cause brief pain, bruising, or, very rarely, infection. Your privacy is protected. All personal information and data will be coded and kept confidential, and will only be used for this research.\n\nThe main benefit to participants is receiving a detailed health assessment, including advanced brain imaging and analysis of gut bacteria, at no cost. There is no direct therapeutic benefit from participating, but the knowledge gained may help improve the understanding and future care of IBS.",[28,96,97],"Anxiety","Depression","2026-06-09",{"date":74,"type":36},{"date":101,"type":36},"2025-12-21",{"date":103,"type":22},"2027-12-30",{"name":105,"class":43},"Tang-Du Hospital",{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":44},"100640097","probiotics-and-biomarkers-in-irritable-bowel-syndrome-100640097","NCT07584278","Probiotics and Biomarkers in Irritable Bowel Syndrome","The Impact of Probiotics on Biomarkers and Symptom Severity in Irritable Bowel Syndrome","BIO-IBS","Inclusion Criteria:\n\n* Diagnosed with IBS according to ROME V criteria\n* IBS-SSS greater than or equal to 75\n* Adult over 18 years old\n* BMI 18.5-35 kg\u002Fm2\n* Able to understand the participant information sheet and willing to comply with the study protocol\n* Able to give informed consent\n* Able to complete the Swedish questionnaires\n\nExclusion Criteria:\n\n* History of any gastroenterology disease including coeliac disease, heart, liver, neurological, or current psychiatric disease, diabetes, any surgery to the abdomen that affects intestinal function (not including cholecystectomy, appendectomy, ceasarean section).\n* The use of opioids 1 month prior to screening and throughout the study\n* The use of probiotic supplements from 14days before randomization and during the study (not including foods with probiotic components)\n* Consumption of antibiotics 3 months prior to screening and throughout the study\n* The start of any new drugs that affect the gastrointestinal tract or symptoms within the last month before the start of the study. As well as the start of new diets of psychological therapy as treatment for IBS symptoms.\n* Participation in any medical research during the last month\n* Clinically relevant lab abnormalities at the time of screening (fecal calprotectin greater than or equal to 150 ug\u002Fg as absolute cutoff. If calprotectin is between 50 - 150ug\u002Fg the decision is made on clinical judgement)\n* Pregnancy, plan to become pregnant during the study, breastfeeding\n* alcohol consumption \\>14 units per week\n* Use of recreational active drugs during 1 month before screening or during the study\n* Use of medication that primarily affects bowel function, transit time, stool consistency 2 weeks before the intervention or during the 12 week intervention period",{"count":115,"type":22},252,[25],"The goal of this double-blind parallel-arm randomized controlled trial is to learn if a probiotic supplement (containing a new strain derived from L. reuteri) alters outcomes related to symptom severity and transit time in adults with irritable bowel syndrome (IBS). The main question it aims to answer is:\n\nDoes the probiotic alter IBS symptom severity?\n\nResearchers will compare the probiotic to a placebo (a lookalike substance that contains no probiotic) to see if the probiotic works to alter outcomes.\n\nParticipants will:\n\nBe randomized to either take the probiotic supplement or placebo supplement daily for 12 weeks.\n\nVisit the lab for 4 study visits (visit 1: screening and informed consent; visit 2: randomization, data collection, beginning the intervention; visit 3: end of intervention and data collection; visit 4: 3 month post intervention follow up and data collection).\n\nProvide biological samples (blood, stool, saliva, urine) Complete questionnaires",[28],[120,121,122,123,124],"probiotic","irritable bowel syndome","ibs symptom severity","oro-anal transit time","randomized controlled trial","2026-05-27",{"date":127,"type":36},"2026-06-01",{"date":129,"type":36},"2026-04-28",{"date":131,"type":22},"2031-05",{"name":133,"class":43},"Sahlgrenska University Hospital",{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":23,"phases":144,"briefSummary":145,"conditions":146,"keywords":149,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":44},"100592960","mechanism-of-fodmap-restriction-on-fgid-patients-100592960","NCT07000227","Mechanism of FODMAP Restriction on FGID Patients","Mechanism of FODMAP Restriction on Gut Microbiota and Gut Barrier Function in Functional Gastrointestinal Disorder Patients : A Randomised Controlled Trial","BRIDGE","Inclusion Criteria:\n\n* Aged 18 and above\n* Able to provide informed consent\n* Those with pre-existing irritable bowel syndrome (IBS) or functional dyspepsia (FD) or both screened by gastroenterologists\n* Meet the ROME III- Asian criteria for FGID\n* Able to communicate in Malay or English language\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* History declared by the participant of pre-existing gastrointestinal disorder, including but not limited to Inflammatory Bowel Disease, Coeliac Disease, Pancreatitis, Gallstone disease (biliary colic, cholecystitis), Diverticulitis\n* Cancer of any kind\n* Patients with reported history of previous resection of any part of the GI tract other than appendix or gall bladder, intestinal stoma\n* Habitual use of opiate analgesics likely to alter bowel function e.g. morphine\n* Use of antibiotics in the preceding two weeks and\u002For in the past one month\n* Consumption of probiotics, prebiotics or fibre supplements in the past one month\n* Enteral feeding or texture modified diet patients\n* Those with cognitive impairment or severe mental disorder (Alzheimer's, schizophrenia, bipolar disorder. etc)\n* Shift workers (e.g. Nurse, doctors)",{"count":143,"type":22},60,[25],"Brief Summary :\n\nThe goal of this clinical trial is to investigate the effects of differing FODMAP diets on gut microbiota, gut barrier function, symptom severity, quality of life, and psychological status in FGID patients. The main question it aims to answer is :\n\nHow does diets with differing FODMAP content affect the gut microbiota, gut barrier function, symptom severity, psychological status and quality of life in patients with FGID ? Researchers will compare low FODMAP diet, Gentle FODMAP diet and Traditional Dietary Advice (NICE guidelines) to see which diet is more suitable and effective for Malaysian FGID patients.\n\nParticipants will :\n\nBe given either low FODMAP diet, Gentle FODMAP diet or Traditional Dietary Advice intervention and will be required to follow the intervention for two weeks.\n\nBe required to provide stool and blood samples during baseline and intervention Record 4 day food diary and complete assessing questionnaires during baseline and intervention",[147,28,148],"Functional Gastrointestinal Disorders (FGIDs)","Functional Dyspepsia",[150,30,148,151,152],"Functional Gastrointestinal Disorder","FODMAP Restriction","Gentle FODMAP","2026-05-08",{"date":155,"type":36},"2026-05-11",{"date":157,"type":36},"2025-07-20",{"date":159,"type":22},"2026-09-30",{"name":161,"class":43},"Universiti Kebangsaan Malaysia Medical Centre",{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":23,"phases":171,"briefSummary":172,"conditions":173,"keywords":176,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":44},"100588376","exclude-or-expose-in-irritable-bowel-syndrome-what-works-for-whom-and-how-100588376","NCT06940596","Exclude or Expose in Irritable Bowel Syndrome: What Works for Whom and How?","Exclude or Expose in Irritable Bowel Syndrome: What Works for Whom, and How? A Randomized Controlled Trial of Internet-Delivered FODMAP Diet Versus Exposure-Based Cognitive Behavioral Therapy","Inclusion Criteria: Each participant must meet all of the following criteria to be enrolled in this trial:\n\n* Living in Australia or the United States\n* Aged 18 years or older\n* Body Mass Index (BMI) \\[Equation\\]18.5kg\u002Fm2 and \\[Equation\\] 34.9kg\u002Fm2\n* Diagnosed with IBS by a General Practitioner, Family Physician, or Gastroenterologist, or Advanced Specialist Dietitian\n* Currently fulfill Rome IV criteria for IBS\n* Symptomatic at the time of recruitment (IBS-SSS \\> 175)\n* Access to a computer and internet\n* Sufficient English language and computer skills to complete a text-based online treatment\n* Willing to make dietary or behavioral changes in line with the allocated treatment program\n* Ability to provide informed consent\n\nExclusion Criteria:Patients meeting any of the following criteria will be excluded from the trial:\n\n* Presence or known history of other GI disease (e.g. coeliac disease, Inflammatory Bowel Disease) or history of gastrointestinal cancer\n* History of major gastrointestinal surgery (not appendectomy, cholecystectomy or hemorrhoidectomy)\n* Individuals who report alarm symptoms (e.g., blood in stool, recent unexplained\u002Funintentional weight loss \\>5% body weight, a recent change in bowel habits if \\>50 years, family history of gastrointestinal cancer or gastrointestinal diseases, large volumes of diarrhea occurring at night, fever associated with gut symptoms, recurrent vomiting, persistent unexplained iron deficiency) will be excluded if appropriate medical investigations have not been conducted, unless written medical approval is provided from a general practitioner, family physical, or gastroenterologist.\n* Diagnosis of major disease that could explain current gastrointestinal symptoms such as severe diabetic, cardiac, liver, neurological, neuropathy disease\n* History or current diagnosis of psychotic disorder or bipolar disorder\n* Current diagnosis of substance abuse disorder or major depressive disorder or active suicidal ideation\n* History or current diagnosis of an eating disorder\n* Current enteral\u002Fparenteral feeding or use of supplemental feeds (e.g. Ensure)\n* Pregnant or lactating or planning to become pregnant during the 12-week intervention period\n* Commenced or change in dose of antibiotics and medications that potentially affect the gastrointestinal transit (e.g. anti-diarrheals and laxatives) in the 3 months preceding study commencement.\n* Commenced taking or changed dose of probiotics, prebiotics, fibre supplements and digestive enzymes in the 3 months preceding study commencement\n* Commenced or change dose in psychotropic medication in the 3 months preceding study commencement\n* Are currently undertaking behavioral therapy for IBS (including cognitive behavioral therapy, CBT), or have undertaken clinician-delivered behavioral therapy for the treatment of IBS\n* Are currently undertaking or have undertaken a dietitian-prescribed and delivered restrictive diet for IBS (e.g., FODMAP diet).",{"count":170,"type":22},235,[25],"This research project will assess how two treatments for irritable bowel syndrome (one dietary and one behavioral) work and for whom. This will be done by assessing moderators (what treatment works for who and in what context) and mediators (how treatment works). Investigators will also assess how the diet and behavioral treatments affect IBS symptoms during treatment. Participants will be randomized to either: i. A FODMAP diet online program that focuses on modifying the consumption of foods high or moderate in fermentable carbohydrates (FODMAPS) to manage IBS symptoms. or, ii. An Exposure-based Cognitive Behavioral Therapy (E-CBT) online program for IBS that focuses on changing symptom-related behaviors which are known to worsen IBS symptoms.",[28,174,175],"Intestinal Diseases","Gastrointestinal Disease",[30,177,178,179,180,181,174,182,183],"FODMAP Diet","Behavior Therapy","Gastrointestinal Diseases","Cognitive Behavioral Therapy","Exposure Based Cognitive Behavioral Therapy","Digestive System Diseases","Low FODMAP Diet","2026-04-29",{"date":186,"type":36},"2026-05-06",{"date":188,"type":36},"2025-05-22",{"date":190,"type":22},"2028-04",{"name":192,"class":43},"University of Melbourne",{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":23,"phases":203,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":44},"100606478","evaluating-the-added-benefit-of-osteopathic-care-to-a-flexi-fodmap-diet-in-fibromyalgia-patients-with-irritable-bowel-syndrome-100606478","NCT07176078","Evaluating the Added Benefit of Osteopathic Care to a Flexi-FODMAP Diet in Fibromyalgia Patients With Irritable Bowel Syndrome","Evaluating the Added Benefit of Osteopathic Care to a Flexi-FODMAP Diet in Fibromyalgia Patients With Irritable Bowel Syndrome: a Randomized Sham-controlled Trial","POISE-IBS-RCT","Inclusion Criteria:\n\nThis study includes participants who meet the following criteria:\n\n1. are over 18 years old;\n2. have a diagnosis of IBS by a medical doctor according to the Rome IV criteria and have an IBS-SSS score of ≥175 (indicating moderate to severe IBS symptoms);\n3. have a medical diagnosis of fibromyalgia or meet the 2016 American College of Rheumatology criteria, characterized by chronic (≥3 months) widespread pain(i.e., a Widespread Pain Index(WPI) score of ≥7 with a Symptom Severity Score of ≥5, or a WPI score of 4-6 with a Symptom Severity Score ≥9 on the Widespread Pain Index).\n\nParticipants will be allowed to use probiotic products and follow a lactose-reduced diet, as long as they kept their usual intake throughout the study, unless a further reduction in lactose was recommended for those assigned to diet therapy. IBS medications, including antidepressants, will be allowed if used consistently at a stable dose for at least 2-3month prior to inclusion. Additionally, participants will need to be willing to adjust their current dietary habits in order to take part in the study.\n\nExclusion Criteria:\n\nThis study excludes participants who meet any of the following criteria:\n\n1. have other gastrointestinal disorders (e.g., inflammatory bowel disease, celiac disease) that could explain the current symptoms;\n2. have diseases affecting gastrointestinal function, including a history of bariatric surgery;\n3. have allergies or food hypersensitivity (other than lactose intolerance);\n4. have any major dietary restrictions or food allergies;\n5. are pregnant or planning pregnancy during the trial (within the next seven months);\n6. have a BMI ≤18 kg\u002Fm²; or 7) have received osteopathic care for IBS and\u002For are already following the FODMAP dietary intervention.",{"count":202,"type":22},96,[25],"Dietary modifications are often recommended as first-line treatment for irritable bowel syndrome, with the FODMAP diet being the most effective intervention to improve global gastrointestinal symptoms. Due to the heterogeneity of symptoms, patients often seek complementary or alternative therapies. This randomized clinical trial aims to determine whether osteopathic care provides additional improvement in gastrointestinal symptoms compared to sham osteopathic care, when both are combined with a flexible FODMAP diet. The trial will also assess the safety and tolerability of osteopathic care.\n\nThe main questions it aims to answer are:\n\nDoes osteopathic care reduce IBS symptom severity more than sham osteopathic care?\n\nDoes osteopathic care improve pain, quality of life, anxiety, fatigue, work productivity, and gut microbiota compared to sham osteopathic care?\n\nDo participants adhere to the flexible FODMAP diet and osteopathic care, and are the effects of osteopathic care maintained at 3- and 6-months post-intervention?\n\nCan pretreatment factors, such as sociodemographic characteristics, IBS severity, predominant symptoms, psychological state, or gut microbiota composition, predict response to osteopathic care?\n\nWhat adverse effects occur with osteopathic care compared to sham care?\n\nParticipants will:\n\nVisit the osteopathy clinic to receive four sessions of real or sham osteopathic care\n\nComplete online assessments before and after the intervention, and at 3- and 6-months post-intervention\n\nProvide stool samples before and after the four osteopathic or sham sessions\n\nKeep a three-day food diary and a ten-day stool diary before and after the intervention, and at 3- and 6-months post-intervention",[28,206],"Fibromyalgia (FM)",[208,30,209,177],"Osteopathic Care","Fibromyalgia","2026-04-13",{"date":212,"type":36},"2026-04-17",{"date":214,"type":36},"2026-01-01",{"date":216,"type":22},"2027-06",{"name":218,"class":43},"Universitair Ziekenhuis Brussel",{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":227,"enrollmentInfo":228,"targetDuration":4,"studyType":23,"phases":230,"briefSummary":231,"conditions":232,"keywords":234,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":247},"100568422","gelsectan-in-the-treatment-of-patients-with-diarrhoea-predominant-irritable-bowel-syndrome-100568422","NCT06681012","Gelsectan® in the Treatment of Patients With Diarrhoea-predominant Irritable Bowel Syndrome","Gelsectan® in the Treatment of Patients With Diarrhoea-predominant Irritable Bowel Syndrome: a Multicentre, Randomized, Double-blind, Parallel-group, Placebo-controlled Study","GIANT","Inclusion criteria:\n\n1. Male or female, age ≥18 years and ≤ 65 years.\n2. Positive diagnosis of IBS, according to Rome IV diagnostic criteria, namely recurrent abdominal pain, on average, at least 1 day\u002Fweek in the last 3 months associated with two or more of the following criteria:\n\n   * related to defecation\n   * associated with a change in frequency stool\n   * associated with a change in form (appearance) of stool The above criteria must be fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.\n3. Positive diagnosis of IBS-D subtype based on Rome IV diagnostic criteria, i.e., more than 25% of bowel movements with a consistency of type 6 or type 7 (loose or watery stools) on the BSFS, and less than 25% of bowel movements with BSFS types 1 or 2 (hard or lumpy stools), on days with at least one abnormal bowel movement.\n4. Negative results to any relevant additional tests or exams whenever deemed appropriate by the Investigator to exclude other disorders or causes of IBS symptoms.\n5. At least one type 6 or type 7 bowel movement based on the BSFS on at least 4 days within the last week prior to randomization.\n6. Weekly average score of 24-hours worst abdominal pain score ≥ 3 on NRS-11 in the last week prior to randomization.\n7. Electronic diary (e-diary) completed on at least 11 of 14 days (≥ 75%) during the screening period (i.e., 2 weeks prior to randomization).\n8. Willingness and capability to fulfil all tasks foreseen by the Clinical Investigation Plan (CIP).\n9. Signed written informed consent.\n10. Females of childbearing potential must have a negative urine pregnancy test (dipstick) at randomization and currently use or agree to use consistently and correctly (i.e., perfect use) a highly effective or acceptable effective contraceptive method for the individual subject and her partner(s) throughout the study treatment period and for at least one full contraceptive cycle (when applicable).\n\nExclusion criteria:\n\n1. Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiovascular, renal, neurological, endocrine, metabolic or hepatic disease) that would preclude participation in this study in the opinion of the Investigator, or abnormal laboratory values that will be deemed clinically significant on the basis of predefined values.\n2. Known perforation and\u002For gastrointestinal obstruction.\n3. Ascertained organic gastrointestinal diseases, including celiac disease, bile acid malabsorption or inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis).\n4. Presence of other intestinal motility disorders, such as biliary dyskinesia, gastroparesis, intestinal pseudo-obstruction, and narcotic bowel syndrome.\n5. Previous major abdominal surgery (uncomplicated appendectomy, cholecystectomy, polypectomy, inguinal hernia surgery, or caesarean section are allowed unless within six months prior to screening).\n6. Active malignancy of any type (except for non-invasive basal or squamous cell carcinoma of the skin), or history of a malignancy other than non-invasive basal or squamous cell carcinoma of the skin. Patients with a history of malignancies that have been surgically removed with no evidence of recurrence for at least five years and no treatment prior to screening are allowed to participate in the study.\n7. History of allergy or hypersensitivity to any of the investigational product ingredients or excipients.\n8. Current use of Gelsectan®.\n9. Use of loperamide or antispasmodics (i.e., direct smooth muscle relaxants, anticholinergic agents and calcium channel blockers) in the 14 days prior to randomization.\n10. Concomitant use (starting from screening) of weak and potent opioids, 5-HT3 antagonists, such as alosetron and ondansetron, bile acid sequestrants, eluxadoline or any other drug\u002Fsupplement known to significantly interfere with abdominal pain, stool frequency and consistency and\u002For intestinal permeability (except for those allowed as rescue therapy starting from randomization), including but not limited to corticosteroids, aminosalicylates, immunosuppressants and biologicals.\n11. Prior and concomitant use of probiotics\u002Fprebiotics\u002Fsynbiotics or rifaximin starting from 28 days prior to randomization. Other oral antibiotics and topical antibiotics are allowed.\n12. Any major psychiatric unstable disorder, including eating disorders, and use of antidepressant or anxiolytic agents, unless used at a stable dose for at least 6 weeks prior to randomization.\n13. History or current evidence of laxative abuse within 5 years prior to screening.\n14. Recent history (within 12 months prior to screening) or suspicion of alcohol abuse or drug addiction.\n15. Treatment with any investigational drug or medical device within 30 days prior to randomization, or current participation in other clinical trials or investigations.\n16. Pregnancy or breastfeeding or intention to look for pregnancy throughout the whole study duration.","65 Years",{"count":229,"type":22},330,[25],"Irritable Bowel Syndrome (IBS) is one of the major Disorders of Gut-Brain Interaction (DGBI) and the most frequent reasons for referral to both primary care providers and gastroenterologists.IBS is not a life-threatening disease, but imposes a significant burden on society, entailing a decrease in patients' Quality of Life (QoL), elevated rates of psychological comorbidities and loss of work productivity, which might be the greatest in subjects with IBS-D, for whom the fear of incontinence in a social situation can be especially debilitating. Moreover, IBS is associated with significant direct and indirect healthcare costs and has a considerable socioeconomic impact on society.\n\nTreatment strategy for IBS is usually based on predominant symptoms and their severity, and requires a strong patient-physician relationship, as well as both non-pharmacological and pharmacological approaches. Lifestyle interventions, such as dietary modifications, physical activity and lifestyle adjustments, and stress reduction\u002Fpsychological therapy represent the most important initial non-pharmacological clinical approach for IBS patients, especially for those with mild disease. First-line pharmacological options for IBS-D include antidiarrheals, mainly loperamide, to control diarrhoea, as well as antispasmodic drugs to relieve IBS symptoms, in particular abdominal pain. Second-line therapies indicated for the treatment of global IBS-D symptoms include rifaximin, 5-Hydroxytryptamine (5-HT)3 receptor antagonists (alosetron, ondansetron and ramosetron) and eluxadoline. Other treatments recommended in patients with IBS-D consist of Tricyclic Anti-Depressants (TCAs) and bile acid sequestrants.\n\nNotably, management of patients with IBS is challenging since diagnosis and treatment could require several therapeutical strategies with often partial and unsatisfactory results. Indeed, most patients with IBS are dissatisfied with their current therapy and 34% report no symptom control, according to the IBS Global Impact Report of 2018.\n\nAt present, there is a growing interest in therapeutic approaches for IBS-D aimed at improving intestinal barrier integrity for a more efficient control of symptoms, considering that an intestinal epithelial barrier dysfunction and mucosal immune activation have been suggested as a central mechanism in IBS-D pathophysiology. In this perspective, film-forming agents capable of protecting the intestinal mucosal barrier, such as Xyloglucan (XG) and Pea protein may represent a valid alternative therapeutic option for the management of IBS-D.\n\nGelsectan® is a CE-marked medical device under the European Union (EU) Medical Device Regulation (MDR) 2017\u002F745, whose classification under the MDR is class III. Gelsectan® contains XG, Pea protein, grape seed extract, and Xylo-Oligosaccharides (XOS) and is indicated for symptomatic relief and prevention of chronic or relapsing diarrhoea, abdominal tension, pain, bloating and flatulence, as well as protection and restoration of intestinal mucosal function. Based on previous non-clinical studies and two clinical investigations, Gelsectan® seems to be safe and exert a protective action on the intestinal mucosa, mediating the restoration of intestinal permeability and the improvement of gastrointestinal symptoms associated with IBS-D. In particular, a 28-day treatment with Gelsectan® significantly reduced IBS-D-associated diarrhoea, abdominal pain and bloating, with no related adverse events in a randomized, placebo-controlled, cross-over clinical study. Moreover, Gelsectan® treatment for 6 months was generally safe and effective in improving IBS severity, diarrhoea and bowel habit, as well as pain and bloating, in a recent multicentre, open-label, prospective, observational study. Of note, Gelsectan® was also mentioned in the recent clinical practice guidelines on IBS-D and functional diarrhoea of the United European Gastroenterology (UEG) and the European Society for Neurogastroenterology and Motility (ESNM), and a recent consensus on IBS conducted by a panel of Belgian gastroenterologists.\n\nWith these premises, the present study aims to further assess the performance and safety of Gelsectan® within the scope of its intended purpose, compared with placebo, on overall abdominal pain and symptoms in patients with IBS-D in a randomized, double-blind, parallel-group clinical study.",[28,233],"Irritable Bowel Syndrome of Diarrhea Type (IBS-D)",[235,28,236],"Gelsectan","Irritable Bowel Syndrome of Diarrhea type (IBS-D)","2026-04-02",{"date":239,"type":36},"2026-04-03",{"date":241,"type":36},"2024-10-22",{"date":243,"type":22},"2027-07",{"name":245,"class":246},"Devintec Sagl","INDUSTRY",12,{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":255,"targetDuration":4,"studyType":23,"phases":257,"briefSummary":258,"conditions":259,"keywords":260,"overallStatus":268,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":44},"100629486","synbiotic-supplement-with-botanical-extracts-for-gut-microbiota-balance-in-irritable-bowel-syndrome-100629486","NCT07475299","Synbiotic Supplement With Botanical Extracts for Gut Microbiota Balance in Irritable Bowel Syndrome","The Impact of a Synbiotic Supplement Containing Botanical Extracts and Multiple Probiotic Strains on Gut Microbiota Balance in Patients With Irritable Bowel Syndrome: A Pilot Prospective Interventional Study","Inclusion Criteria:\n\n* Adults aged ≥18 years\n* Clinically confirmed diagnosis of Irritable Bowel Syndrome documented in the medical record\n* Presence of recurrent gastrointestinal symptoms such as bloating, abdominal discomfort, gas, or bowel habit disturbances (constipation, diarrhea, or mixed pattern) considered clinically relevant by the participant\n* Ability to understand the study procedures and provide written informed consent\n* Willingness to participate for the full duration of the study (approximately 16 weeks) and attend study visits (T0, T1, and Tfinal)\n* Willingness to provide biological samples (blood and stool samples for microbiota analysis) according to the study protocol\n\nExclusion Criteria:\n\n* Known or suspected organic gastrointestinal disease explaining the symptoms (e.g., inflammatory bowel disease, untreated celiac disease, gastrointestinal malignancy)\n* Presence of alarm symptoms such as unexplained gastrointestinal bleeding, significant unintentional weight loss, persistent fever, severe anemia, or signs of acute infection\n* Acute gastrointestinal infection at the time of screening\n* Use of antibiotics within the previous 4-8 weeks prior to baseline\n* Use of probiotic, prebiotic, or microbiota-modifying supplements within 4 weeks prior to baseline that cannot be discontinued\n* Planned major dietary changes or initiation of new treatments for gastrointestinal symptoms during the study period\n* Pregnancy or breastfeeding\n* Known allergy or hypersensitivity to any component of the investigational supplement\n* Any severe comorbid condition or circumstance that, in the opinion of the investigator, could increase risk to the participant or interfere with study results",{"count":256,"type":22},8,[25],"The goal of this clinical trial is to evaluate whether a synbiotic dietary supplement containing botanical extracts and multiple probiotic strains can improve gastrointestinal symptoms and modulate gut microbiota composition in adults diagnosed with Irritable Bowel Syndrome (IBS).\n\nThe main questions it aims to answer are:\n\nDoes supplementation with the synbiotic product improve functional gastrointestinal symptoms associated with IBS (e.g., bloating, abdominal discomfort, and bowel habit disturbances)?\n\nDoes the intervention lead to measurable changes in gut microbiota composition and selected biological markers compared with baseline measurements?\n\nParticipants will:\n\nundergo baseline evaluation including symptom assessment, blood tests, and stool sample collection for gut microbiota analysis;\n\ncomplete an 8-week observation period without intervention to establish baseline variability;\n\ntake the synbiotic supplement once daily for 8 weeks;\n\nrepeat clinical assessments, blood tests, and gut microbiota analysis during follow-up visits.",[28],[261,262,263,264,265,266,267,30],"IBS","Synbiotic","Botanical Extracts","Probiotics","Gastrointestinal Symptoms","Digestive Health","Microbiota Diversity","NOT_YET_RECRUITING","2026-03-14",{"date":271,"type":36},"2026-03-16",{"date":273,"type":22},"2026-04",{"date":275,"type":22},"2027-01",{"name":277,"class":43},"Iuliu Hatieganu University of Medicine and Pharmacy",{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":227,"enrollmentInfo":285,"targetDuration":4,"studyType":23,"phases":287,"briefSummary":290,"conditions":291,"keywords":292,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":44},"100629957","phase-1-safety-and-efficacy-of-lyophilized-faecal-microbiota-transplantation-via-capsules-in-treatment-of-irritable-bowel-syndrome-100629957","NCT07481422","Safety and Efficacy of Lyophilized Faecal Microbiota Transplantation Via Capsules in Treatment of Irritable Bowel Syndrome","LYO-IBS","Inclusion Criteria:\n\n* 18-65 years of age\n* disease activity defined by an IBS-Symptom Severity Score (IBS-SSS) of more than 175\n* symptoms refractory to conservative medical therapy (hyoscine salts, osmotic laxatives such as polyethylene glycol, loperamide, rifaximin, tricyclic antidepressants, SSRIs or other antidepressants, peppermint oil)\n* negative evaluation for coeliac disease\n* signed informed consent\n\nExclusion Criteria:\n\n* pregnant or breastfeeding women\n* women of childbearing potential who are unwilling to use an acceptable method of birth control\n* severely immunocompromised or immunosuppressed (organ transplant recipients, those with neutropenia with an absolute neutrophil count of \\\u003C500 cells per mm3, those receiving current treatment with antineoplastic drugs, HIV positive)\n* gastrointestinal symptoms explained by an alternative diagnosis (underlying IBD, infectious enteritis)\n* severe allergy to capsule components\n* therapy with new antidepressants or had a change in antidepressant dose within previous 3 months\n* serious medical comorbidities (including neurological or psychiatric comorbidities)\n* treatment with antibiotics 3 months before enrolment\n* previous history of FMT at any time in the past\n* unwillingness to ingest the capsules",{"count":286,"type":22},70,[288,289],"PHASE1","PHASE2","The goal of this clinical trial is to learn if oral capsules containing lyophilized fecal microbiota transplantation (FMT) can safely and effectively treat refractory irritable bowel syndrome (IBS) in adults aged 18-65 years. The main questions it aims to answer are:\n\nDoes treatment with lyophilized FMT capsules reduce IBS symptom severity compared with placebo?\n\nDoes treatment with lyophilized FMT capsules improve quality of life, anxiety, and depression in patients with IBS?\n\nAre there differences in the frequency of adverse events between participants receiving FMT capsules and those receiving placebo?\n\nResearchers will compare lyophilized FMT capsules to placebo capsules to see if FMT reduces IBS symptoms and improves quality of life and mental health.\n\nParticipants will:\n\nBe randomly assigned to receive either lyophilized FMT capsules or placebo capsules for three consecutive days.\n\nTake the capsules under supervision after receiving a proton pump inhibitor before the first dose.\n\nComplete questionnaires assessing symptom severity, quality of life, anxiety, and depression at baseline, 4 weeks, and 12 weeks after treatment.\n\nAttend follow-up visits at 4 weeks and 12 weeks after treatment and receive a telephone follow-up call 10 days after capsule ingestion.\n\nReport any adverse events and have vital signs and medical information monitored during follow-up.\n\nThis study will help determine whether oral lyophilized FMT capsules are a safe and effective treatment option for adults with refractory IBS.",[28],[293,30,261,294],"FMT","Lyophilization","2026-03-13",{"date":297,"type":36},"2026-03-18",{"date":299,"type":22},"2026-03-15",{"date":301,"type":22},"2027-12-15",{"name":303,"class":43},"University of Rijeka",{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":311,"enrollmentInfo":312,"targetDuration":4,"studyType":23,"phases":313,"briefSummary":314,"conditions":315,"keywords":316,"overallStatus":268,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":44},"100618906","new-microbiota-endocrine-axis-in-fructose-malabsorption-caused-visceral-hypersensitivity-in-irritable-bowel-syndrome-100618906","NCT07337707","New Microbiota-endocrine Axis in Fructose Malabsorption-caused Visceral Hypersensitivity in Irritable Bowel Syndrome.","ENDOLORII","Inclusion Criteria:\n\nFor all groups:\n\n* Patients with IBS defined by current Rome criteria (currently IV)\n* Adult, aged 18 to 75\n* Regulatory criteria :\n\n  * Membership of a social security scheme\n  * Adult having read and understood the information letter and signed the consent form\n  * Woman of childbearing age with effective contraception for the duration of the study such as oestroprogestins, intrauterine device, tubal ligation, vasectomised partner or sexual abstinence (no heterosexual intercourse for 1 month and a negative urine pregnancy test at inclusion).\n  * Postmenopausal women: confirmatory diagnosis (non-medically induced amenorrhoea for at least 12 months prior to the inclusion visit or biologically documented)\n  * Women of childbearing age who have been rendered surgically infertile (e.g. hysterectomy, bilateral salpingectomy, bilateral oophorectomy).\n\nFor the IBS group with fructose malabsorption and visceral hypersensitivity (named group of interest, MalF-HyperSens) (1):\n\n* 25g fructose breath test in favour of fructose malabsorption\n* Rectal barostat finding visceral hypersensitivity\n\nFor the IBS group with fructose malabsorption and without visceral hypersensitivity (known as the MalF-NormoSens group) (2):\n\n* Fructose breath test at 25g dose in favour of fructose malabsorption\n* Rectal barostat finding no visceral hypersensitivity\n\nFor the IBS group without fructose malabsorption and visceral hypersensitivity (named NormoF-HyperSens group) (3):\n\n* Fructose breath test at 25g dose in favour of no fructose malabsorption\n* Rectal barostat finding visceral hypersensitivity\n\nFor the IBS group without fructose malabsorption or visceral hypersensitivity (called the NormoF-NormoSens group) (4):\n\n* Fructose breath test at a dose of 25g in favour of the absence of fructose malabsorption\n* Rectal barostat finding no visceral hypersensitivity\n\nExclusion Criteria:\n\n* Patient who has not undergone a fructose breath test or a barostat in our department in the last 10 years.\n* Patient with organic digestive pathology (chronic inflammatory bowel disease, microscopic colitis, digestive cancer, celiac disease)\n* Systemic antibiotic use (oral, IV or IM) in the month prior to inclusion\n* Regulatory criteria :\n\n  * Pregnant or parturient or breast-feeding woman or proven absence of contraception,\n  * Person deprived of liberty by an administrative or judicial decision or person placed under court protection \u002F sub- guardianship or curatorship,\n  * Person undergoing research participating in another trial \u002F having participated in another trial within a period of 2 weeks,\n  * History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or preventing him\u002Fher from giving informed consent.","75 Years",{"count":143,"type":22},[25],"Irritable bowel syndrome (IBS) affects around 4% of the general population and remains the most common functional bowel disorder. It is defined by the Rome criteria as the presence of abdominal pain associated with transit disorders. The impact on quality of life and the associated costs make it a public health problem.\n\nVisceral hypersensitivity is one of the functional markers of the disease and plays a part in the genesis of symptoms. It could therefore also be a therapeutic target to be explored. Diet and the intestinal microbiota are also part of the recognised pathophysiological mechanisms of this disease. Carbohydrates malabsorbed by the intestine are metabolised by the microbiota, which may contribute to the genesis of symptoms. Among these carbohydrates, fructose appears to be of particular interest. Its absorption capacity is limited, yet fructose consumption is increasing. Fructose malabsorption at a dose of 25 g is present in 22% of IBS patients. Fructose malabsorption is also associated with visceral hypersensitivity. However, the mechanism of this association remains unknown. In models of malabsorbed mice with visceral hypersensitivity, an increase in cholecystokinin was found in the terminal ileum and cecum, suggesting a potential role for this hormone in this model of IBS. However, the underlying mechanism remains poorly understood.\n\nThe objective is to determine if microbiota signature is specific of visceral hypersensitivity associated with fructose malabsorption in IBS patients.\n\n60 patients with IBS will be included in the study in 4 groups:\n\n1. n=15 patients with visceral hypersensitivity and fructose malabsorption\n2. n=15 patients with visceral hypersensitivity and without fructose malabsorption\n3. n=15 patients without visceral hypersensitivity and with fructose malabsorption\n4. n=15 patients without visceral hypersensitivity and without fructose malabsorption\n\nAll patients will filled validated questionnaires and 4-days food diary. They will also have a urinary permeability test (lactulose\u002Fmannitol test) and collected stools samples for microbiota analysis.",[28],[317,318,319],"visceral hypersensitivity","fructose malabsorption","microbiota","2026-01-02",{"date":322,"type":36},"2026-01-13",{"date":324,"type":22},"2026-02",{"date":326,"type":22},"2027-08",{"name":328,"class":43},"University Hospital, Rouen",{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":90,"sex":17,"minAge":336,"maxAge":227,"enrollmentInfo":337,"targetDuration":4,"studyType":23,"phases":339,"briefSummary":340,"conditions":341,"keywords":342,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":44},"100567494","irritable-bowel-syndrome-and-control-volunteers-diet-challenge-100567494","NCT06668922","Irritable Bowel Syndrome and Control Volunteers: Diet Challenge","Fecal Bile Acids, Fecal Short Chain Fatty Acids and the Intestinal Microbiota in Patients With Irritable Bowel Syndrome (IBS) and Control Volunteers: Diet Challenge","Inclusion Criteria:\n\n* Age 18-75\n* Individuals with irritable bowel syndrome (IBS)\n* Healthy volunteers (healthy controls) with no prior history of gastrointestinal (GI) disease or symptoms\n* No dietary restrictions other than vegetarian\n\nExclusion Criteria:\n\n* Inflammatory bowel disease, celiac disease, or certain types of abdominal cancer, as well as those with thyroid or liver issues\n* Abdominal surgery or abdominal radiation within 6 months of study participation, with an exception for C-section or gallbladder removal\n* Use of any prescription, over the counter, or herbal medications known to affect gastrointestinal function or study interpretation, such as opioids, inflammatory drugs or certain antidepressants, within 6 months prior to study participation for healthy volunteers, or within 2 days of study participation for participants with IBS.\n* An exception will be permitted for limited use of stable low doses of antidepressants for individuals who have been taking them for a period greater than one month.\n* Rescue medication such as Bisacodyl (dulcolax) to relieve severe constipation and allow for stool collection will be permitted when needed.\n* Use of Ozempic and Ozempic-type medications\n* Pregnant or breastfeeding women\n* Antibiotic use within 3 months of study participation\n* Use of prebiotics or probiotics within the 2 weeks before the study initiation\n* Regular tobacco use within the past 6 months","17 Years",{"count":338,"type":22},72,[25],"The study will investigate the relationship between fecal bile acids, short-chain fatty acids (SCFAs), and the gut microbiota in irritable bowel syndrome (IBS). The central hypothesis of this study is that specific shifts in the GI microbiome composition correlate with altered colonic SCFAs and BAs and contribute to IBS symptoms. Primary aims include: (a) identifying GI microbiome signatures in IBS subtypes (IBS-C and IBS-D) and matched controls, and test if microbiome signatures in these groups correlate with fecal SCFAs and bacterial fermentation of an indigestible carbohydrate (inulin) after a dietary challenge (fecal inulin), and (b) determining if GI microbiome signatures in IBS subtypes and controls correlate with fecal BAs or markers of SCFA production (fecal SCFAs or inulin) and test if BAs correlate with fecal SCFAs or inulin.\n\nThe target population is adults ages 18-65 years meeting Rome IV criteria for IBS (both diarrhea- and constipation-predominant, IBS-D and IBS-C) and asymptomatic controls. Primary outcomes will be fecal bile acid excretion and profile, short-chain fatty acid excretion and profile, colonic transit, and fecal microbiota. Secondary outcomes will be stool characteristics based on responses to validated bowel diaries. Stool samples will be collected from participants during the last 2 days of a 4-day 100 g fat diet and split into 3 samples for fecal microbiota, SCFA, and bile acid analysis.",[28],[343,261,344,345,346,347,319],"irritable bowel syndrome","short-chain fatty acids","SCFAs","bile acids","fecal inulin","2025-12-08",{"date":350,"type":36},"2025-12-09",{"date":352,"type":36},"2024-11-28",{"date":354,"type":22},"2030-12-31",{"name":356,"class":43},"University of California, Los Angeles",{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":261,"eligibilityCriteria":363,"healthyVolunteers":90,"sex":17,"minAge":364,"maxAge":18,"enrollmentInfo":365,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":367,"conditions":368,"keywords":369,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":379,"locationsCount":44},"100614726","diet-and-motility-in-ibs-100614726","NCT07283341","Diet and Motility in IBS","The Role of Diet and Gastrointestinal Motility in Irritable Bowel Syndrome (IBS)","Inclusion Criteria:\n\nCases:\n\n1. Males and females age 8 - 18 years\n2. Diagnosis of irritable bowel syndrome (IBS).\n3. Parental\u002Fguardian permission (informed consent) and child assent\n\nControls:\n\n1. Males and Females age 8-18 years\n2. No diagnosis of abdominal pain disorder\n3. Parental\u002Fguardian permission (informed consent) and child assent\n\nExclusion Criteria:\n\nCases:\n\n1. Allergy to adhesives\n2. Inability to cooperate with study design\n3. Antibiotic intake in the past 4 weeks\n4. Inflammatory gastrointestinal disorder diagnosis\n\nControls:\n\n1. Allergy to adhesives\n2. Inability to cooperate with study design\n3. Antibiotic intake in the past 4 weeks\n4. Inflammatory gastrointestinal disorder diagnosis","8 Years",{"count":366,"type":22},90,"The goal of this observational study is to identify factors that influence symptoms in children with irritable bowel syndrome (IBS), to find ways to make diet treatments work better and possibly create personalized plans to help each child with IBS feel better. The main question it aims to answer is:\n\n1. What types of food do the kids eat and how do these diets relate to their symptoms?\n2. Is there any motility pattern that we can identify from the kids with or without IBS using a wearable patch?\n3. What kinds of bacteria and chemicals are found in the gut and urine of children with IBS, and how are these linked to their IBS symptoms?\n\nParticipants will use the wearable patch, answer questionnaires, collect stool and urine samples, and recall their 24 hours dietary.",[28],[30,370,371,372],"Diet","Motility","Wireless Patch System","2025-12-02",{"date":375,"type":36},"2025-12-15",{"date":377,"type":36},"2023-07-31",{"date":216,"type":22},{"name":380,"class":43},"Children's Hospital of Philadelphia",{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":17,"minAge":387,"maxAge":4,"enrollmentInfo":388,"targetDuration":390,"studyType":55,"phases":4,"briefSummary":391,"conditions":392,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":44},"100613072","real-world-study-on-fecal-microbiota-transplantation-long-term-effectiveness-and-safety-statistics-100613072","NCT07261826","Real-World Study on Fecal Microbiota Transplantation: Long-Term Effectiveness and Safety Statistics","Inclusion Criteria:\n\n* Diagnosed with one of the target diseases.\n* Age ≥ 3 years.\n* Have received at least one Fecal Microbiota Transplantation (FMT) treatment.\n* Availability of complete baseline and follow-up data for analysis.\n* Provide signed informed consent (for the prospective cohort) OR consent for the use of clinical data (for the retrospective cohort).\n\nExclusion Criteria:\n\n* Clinical data is severely missing, making efficacy assessment impossible.\n* Presence of severe complications that may jeopardize safety or confound the study results.","3 Years",{"count":389,"type":22},4000,"5 Years","This is a large-scale observational study aiming to evaluate the long-term effectiveness and safety of Fecal Microbiota Transplantation (FMT). FMT is a procedure that transfers gut bacteria from healthy donors to patients to restore a balanced gut microbiome.\n\nThe study will follow approximately 4,000 patients who have received or will receive FMT for conditions like recurrent C. difficile infection, inflammatory bowel disease, functional gastrointestinal disorders, and certain neurological conditions.\n\nThe main goals are to:\n\n* Assess the disease remission rates at 3 months, 1 year, and 5 years after FMT.\n* Monitor the long-term safety and any potential side effects.\n* Identify factors that may influence how well a patient responds to the treatment.\n\nThis research will use both existing patient data (retrospective cohort) and newly collected data from future patients (prospective cohort). The findings are expected to help improve and standardize FMT treatment for better patient care.",[393,394,395,28,396,397,398,399,400],"Clostridium Difficile Infection Recurrence","Ulcerative Colitis (UC)","Crohn Disease (CD)","Chronic Functional Constipation","Chemotherapy-Induced Colitis","PD-1 Associated Enteritis","Autism Spectrum Disorder","Incomplete Intestinal Obstruction","2025-11-22",{"date":403,"type":36},"2025-12-03",{"date":405,"type":36},"2025-09-01",{"date":407,"type":22},"2028-06-30",{"name":409,"class":43},"Chen QiYi",{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":4,"eligibilityCriteria":416,"healthyVolunteers":12,"sex":17,"minAge":417,"maxAge":418,"enrollmentInfo":419,"targetDuration":4,"studyType":23,"phases":421,"briefSummary":422,"conditions":423,"keywords":428,"overallStatus":268,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":439},"100610081","feasibility-study-of-a-guided-imagery-therapy-mobile-application-for-functional-abdominal-pain-disorders-in-children-100610081","NCT07222943","Feasibility Study of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children","Open-Labelled Feasibility Study of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children","Inclusion Criteria:\n\n* Texas Children's Pediatrics patients 7 to 12 years old at enrollment\n* A Rome IV Functional Abdominal Pain Disorder as defined by a 2-week abdominal pain and stooling diary\n* Both children and their primary caregivers must be able to read and communicate in English proficiently to understand the intervention's audio therapy sessions and psychometric instruments.\n\nExclusion Criteria:\n\n* Previous abdominal surgeries\n* Co-morbid conditions associated with abdominal pain (e.g., cystic fibrosis)\n* Autism\n* Significant development delay\n* Psychosis\n* Prior experience with cognitive behavioral therapy or guided imagery therapy to treat chronic abdominal pain\n* Alarm symptoms that warrant further medical evaluation (e.g., blood in stool)","7 Years","12 Years",{"count":420,"type":22},36,[25],"Chronic abdominal pain is common among children, and the majority of cases are attributed to functional abdominal pain disorders. One approach to treating these disorders is by using psychological therapies. This clinical trial aims to see how well pre-recorded guided imagery therapy sessions help children's abdominal pain when delivered via a mobile application (app) on a smartphone or tablet.\n\nParticipants will complete a baseline abdominal pain and stooling diary to determine eligibility, as well as other surveys. Eligible participants will be given access to the guided imagery therapy mobile application.\n\nThis intervention asks participants to listen to a 10- to 15-minute GIT session 5 out of 7 days per week for 8 weeks, in addition to their usual care for their abdominal pain. Then, participants will complete another abdominal pain and stooling diary, along with other psychometric surveys, at the end of this intervention period. Participants will also collect another diary and surveys 3 months post-treatment.",[424,28,147,425,426,427,148],"Functional Abdominal Pain Disorders","Gastrointestinal and Digestive Disorder","Abdominal Pain\u002F Discomfort","Pain",[429,343],"abdominal pain","2025-10-28",{"date":432,"type":36},"2025-10-30",{"date":434,"type":22},"2025-12-01",{"date":436,"type":22},"2026-11-30",{"name":438,"class":43},"Baylor College of Medicine",2,{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":446,"eligibilityCriteria":447,"healthyVolunteers":12,"sex":17,"minAge":448,"maxAge":18,"enrollmentInfo":449,"targetDuration":4,"studyType":23,"phases":451,"briefSummary":452,"conditions":453,"keywords":454,"overallStatus":268,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":461,"leadSponsor":463,"locationsCount":44},"100602600","probiotic-mixture-l-rhamnosus-gg-and-l-plantarum-299v-in-pediatric-irritable-bowel-syndrome-100602600","NCT07125625","Probiotic Mixture (L. Rhamnosus GG and L. Plantarum 299V) In Pediatric Irritable Bowel Syndrome","Randomized Double Blind Placebo Controlled Trial on a Probiotic Mixture (L. Rhamnosus GG Plus L. Plantarum 299V) in Pediatric Irritable Bowel Syndrome: Clinical Efficacy and Multiomics Approach","PRIME","Inclusion Criteria:\n\n* Children aged 4-18 years;\n* Irritable Bowel Syndrome according to Rome IV criteria\n* Average daily pain rate of at least 3 out of 10 VAS met during run-in period •-Written informed consent of parent's\u002Flegal tutor and verbal or written assent of the patient based on the minor's maturity\n\nExclusion Criteria:\n\n* Presence of other gastrointestinal diseases (inflammatory bowel disease, pancreatitis, chronic liver disease, eosinophilic esophagitis, peptic ulcer disease, celiac disease, pseudo-obstruction, small bowel bacterial overgrowth, or Hirschsprung's disease);\n* Significant chronic health condition requiring specialty care (e.g., lithiasis, ureteropelvic junction obstruction, sickle cell, cerebral palsy, hepatic, hematopoietic, renal, endocrine, or metabolic diseases) that could potentially impact the child's ability to participate or confound the results of the study.\n* Primary or secondary immunodeficiency;\n* Malnutrition;\n* History of abdominal surgery in the past 3 months.;\n* Chronic or acute infectious diseases (viral, bacterial, parasitic) in progress;\n* Rome IV criteria diagnosis of functional constipation.\n* Use of probiotics\u002Fantibiotics within 4 weeks prior to enrolment;\n* Current pregnancy or breastfeeding;\n* Psychiatric conditions that reduce compliance with the protocol.","4 Years",{"count":450,"type":22},124,[25],"What is this study about? This clinical study aims to investigate whether a specific combination of probiotics-Lactobacillus rhamnosus GG and Lactobacillus plantarum 299V-can help children and adolescents with Irritable Bowel Syndrome (IBS). IBS is a common digestive condition in children, causing abdominal pain, bloating, and changes in bowel habits (either diarrhoea, constipation, or alternating between the two). These symptoms can seriously affect a child's daily life and wellbeing.\n\nThe study is coordinated by the University of Bari, in collaboration with the University of Udine, and led by Prof. Ruggiero Francavilla.\n\nWhy is this study being done? Although probiotics are increasingly used in IBS, solid scientific evidence in children is still limited. This study will assess whether the chosen probiotic mix improves symptoms, bowel habits, and quality of life in young people with IBS. It will also investigate how the probiotics affect gut bacteria (microbiota) and the chemicals produced by the body (metabolomics), to better understand how these changes might help relieve symptoms.\n\nWho can take part? Children and adolescents aged 4 to 18 years with a diagnosis of IBS (based on international Rome IV criteria) who experience abdominal pain on a daily basis.\n\nChildren with other significant medical conditions, recent surgery, or ongoing infections, as well as those taking antibiotics or other probiotics shortly before the study, cannot participate.\n\nHow does the study work? The study is a randomised, double-blind, placebo-controlled trial, meaning that some children will receive the probiotic drops, and others will receive placebo drops (which do not contain probiotics), and neither the participants nor the doctors will know who is receiving which treatment. This is the best way to test whether the probiotics really work.\n\nEach participant will be involved in the study for about 14 weeks, divided into:\n\nA 2-week \"run-in\" period to confirm eligibility.\n\nAn 8-week treatment period (probiotic or placebo).\n\nA 4-week follow-up.\n\nThe probiotics\u002Fplacebo are taken as 20 drops once daily for 8 weeks.\n\nThroughout the study, children and parents will be asked to keep a daily diary of abdominal pain and bowel habits, and to complete validated questionnaires on symptom severity and quality of life. Stool and urine samples will also be collected at different time points to analyse changes in gut bacteria and body metabolism.\n\nWhat are the aims of the study?\n\nPrimary aim:\n\nTo see whether the probiotics reduce abdominal pain by at least 30% compared to the start of the study.\n\nSecondary aims:\n\nTo check if bowel habits improve (stool consistency and frequency).\n\nTo assess improvements in quality of life.\n\nTo analyse whether the probiotics cause positive changes in gut bacteria and metabolic profiles.\n\nTo ensure that the treatment is safe and well-tolerated.\n\nWhat are the possible risks and benefits? The probiotic mixture used in this study has been studied in children before and is generally considered safe. The study includes careful monitoring for any side effects.\n\nParticipants may or may not experience an improvement in symptoms. However, the information gained from the study will help doctors better understand how probiotics work in IBS and may benefit future patients.\n\nWhat are participants' rights? Participation is voluntary, and families may withdraw their child from the study at any time, without affecting the child's medical care. The study has been approved by an independent ethics committee and complies with all European and Italian regulations regarding research in children.\n\nAll personal data and medical information will be treated confidentially and securely, in accordance with privacy laws.\n\nWhere is the study taking place? The study is being conducted at the Paediatric Gastroenterology Unit of the University of Bari Aldo Moro and the Paediatric Unit of the University of Udine. These centres are national referral centres for children with gastrointestinal problems.\n\nWho is funding and organising the study? The study is sponsored and conducted by the University of Bari. The probiotic and placebo products are provided by Dicofarm S.p.A., who also ensures that the placebo and probiotic products look and taste the same to maintain the study's blinding.",[28],[455,456,343],"food supplement","probiotics","2025-08-13",{"date":459,"type":36},"2025-08-15",{"date":405,"type":22},{"date":462,"type":22},"2027-06-30",{"name":464,"class":43},"University of Bari",{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":90,"sex":17,"minAge":18,"maxAge":471,"enrollmentInfo":472,"targetDuration":473,"studyType":55,"phases":4,"briefSummary":474,"conditions":475,"keywords":4,"overallStatus":268,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":4},"100596880","deep-learning-based-confocal-laser-microendoscopy-feature-atlas-construction-and-its-application-in-intelligent-diagnosis-of-irritable-bowel-syndrome-100596880","NCT07051226","Deep Learning-Based Confocal Laser Microendoscopy Feature Atlas Construction and Its Application in Intelligent Diagnosis of Irritable Bowel Syndrome","Inclusion Criteria:\n\n* ①Healthy control group and test group of IBS with clear clinical diagnosis (Rome IV diagnostic criteria). Healthy controls are free of gastrointestinal symptoms, test results (blood count, CRP, ESR, etc.) and colonoscopy abnormalities.Patients with IBS have recurrent abdominal pain (≥1 day per week on average in the past 3 months), with onset ≥6 months before diagnosis, and the abdominal pain is accompanied by at least two of the following three symptoms: pain related to defecation, change in stool frequency, and change in the shape (appearance) of the feces, and other organic or metabolic disorders are excluded.② Age: between 18 and 80 years old.③ Probe-based confocal Laser Endomicroscopy (pCLE) is required, and patients have good compliance. ④ Normal coagulation function, and biopsies can be obtained for pathological examination.⑤ Voluntary signing of informed consent.\n\nExclusion Criteria:\n\n* Fluorescein sodium allergy. ②Contraindications to colonoscopy (pregnant or breastfeeding patients, uncooperative psychiatric patients with severe mental disorders, colonic obstruction) or inadequate bowel preparation (Boston Bowel Preparedness Scale score of \\\u003C2 for any colonic segment).③ Comorbidities with major organ dysfunction (with severe cardiopulmonary disease) or impaired renal function (blood creatinine \\>450umol\u002FL). ④ Other conditions that, in the judgment of the investigator, make it unsuitable for participation in the study (inflammatory bowel disease, infected IBS, having taken nonsteroidal anti inflammatory drugs, corticosteroids or antibiotics within the last year, etc.).","80 Years",{"count":366,"type":22},"1 Day","In this study, the healthy control group and IBS patients are taken as the research subjects, and CLE is applied to image and analyze the enrolled persons respectively, to derive and compare the characteristic microstructural images of the healthy control group with those of the IBS patients, to establish a diagnostic model of IBS by using deep learning and to evaluate the diagnostic efficacy of the model for IBS.Participants will undergo colonoscopy and confocal laser microendoscopy, and IBS patients will undergo targeted biopsy in CLE to observe suspicious lesions and lesion margins, and specimens will undergo HE staining and immunohistochemistry testing.\n\nTranslated with DeepL.com (free version)",[28],"2025-06-26",{"date":478,"type":36},"2025-07-04",{"date":480,"type":22},"2025-07-01",{"date":482,"type":22},"2027-12-31",{"name":484,"class":43},"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University",{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":90,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":494,"conditions":495,"keywords":4,"overallStatus":268,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":4},"100594214","diagnostic-study-for-differentiating-functional-from-organic-diseases-in-patients-with-lower-git-symptoms-100594214","NCT07016529","Diagnostic Study for Differentiating Functional From Organic Diseases in Patients With Lower GIT Symptoms","Diagnostic Utility of Myeloperoxidase for Differentiating Irritable Bowel Syndrome From Inflammatory Bowel Disease in Patients With Lower GIT Symptoms","Inclusion Criteria:\n\n* Adults (≥18 years) presenting with chronic lower gastrointestinal symptoms, such as diarrhea, abdominal pain, or altered bowel habits, for a duration exceeding 6 weeks.\n* Patients with no prior diagnosis of IBD or IBS.\n* Patients willing to provide informed consent and comply with study requirements.\n* Those without recent use of immunosuppressants or anti-inflammatory medications that could affect biomarker levels\n\nExclusion Criteria:\n\n* Patients with a confirmed diagnosis of IBD and currently on treatment.\n* Those with acute gastroenteritis, infectious colitis, or positive stool cultures for pathogens.\n* Patients diagnosed with colorectal cancer, celiac disease, or other known organic GI disorders.\n* Recent antibiotic, NSAID, or corticosteroid use within the past 4 weeks.\n* Pregnant or lactating women.",{"count":493,"type":22},100,"The study is intended to find a new trusted, cost-effective biomarker for differentiating irritable bowel syndrome from inflammatory bowel disease to decrease the use of unnecessary invasive methods in patients with irritable bowel syndrome",[28,496],"Inflammatory Bowel Disease (IBD)","2025-06-04",{"date":499,"type":36},"2025-06-11",{"date":501,"type":22},"2025-06-10",{"date":503,"type":22},"2025-12-20",{"name":505,"class":43},"Sohag University",{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":512,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":17,"minAge":514,"maxAge":515,"enrollmentInfo":516,"targetDuration":4,"studyType":23,"phases":518,"briefSummary":519,"conditions":520,"keywords":525,"overallStatus":268,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":536,"leadSponsor":538,"locationsCount":4},"100588980","phase-2-a-flexible-clinical-trial-to-test-if-freeze-dried-fecal-microbiota-therapy-helps-treat-diarrhea-predominant-irritable-bowel-syndrome-or-prevent-recurring-c-difficile-infections-100588980","NCT06948461","A Flexible Clinical Trial to Test if Freeze-dried Fecal Microbiota Therapy Helps Treat Diarrhea-predominant Irritable Bowel Syndrome or Prevent Recurring C. Difficile Infections.","An Adaptive Basket Trial to Evaluate Efficacy of Lyophilized Fecal Microbiota Therapy in Management of Irritable Bowel Syndrome-diarrhea Predominant or Prevention of Recurrent Clostridioides Difficile Infection","ORAL-LYO-FMT","Inclusion Criteria:\n\n* 19 years of age and older\n* Able to provide informed consent\n* Must have at least one of the 3 following conditions:\n\n  1. Irritable bowel syndrome with diarrhea- predominant (IBS-D) as reported by patients of type 6 or 7 in Bristol stool chart and Rome IV diagnostic criteria:\n\n     1. Recurrent abdominal pain\u002Fdiscomfort\\*\\* at least 3 days\u002Fmonth in last 3 months associated with ≥2 of the following:\n     2. Symptom improvement with defecation;\n     3. Onset associated with change in stool frequency;\n     4. Onset associated with change in stool formation (with this last criterion fulfilled for last 3 months with symptom onset \\> 6 months prior to diagnosis\n  2. Primary or 1 episode recurrent Clostridioides difficile infection which is actively treated with CDI antibiotic (oral vancomycin, oral metronidazole or fidaxomicin) and clinically responding to treatment based on physician assessment at the time of recruitment.\n  3. 2 or more episodes of recurrent Clostridioides difficile infection, which is actively treated with CDI antibiotic (oral vancomycin, oral metronidazole or fidaxomicin) and clinically responding to treatment based on physician assessment at the time of recruitment.\n\nExclusion Criteria:\n\n1. Planned or actively taking other investigational product\n2. Unable to tolerate FMT or take oral medications.\n3. Requiring systemic antibiotic therapy at the time of FMT\n4. Actively taking probiotics \\[Consumption of yogurt is permitted\\]\n5. Severe allergy to any food and\u002For medications\n6. Major open abdominal surgery within the past 60 days\n7. Receipt of chemotherapy or radiation within 8 weeks of screening.\n8. Active small bowel obstruction.\n9. Those who are pregnant or plan to be pregnant within 3 months of the study. This will be determined on history alone at time of study entry and subsequent follow up.\n10. Those who are breastfeeding or plan to breast feed during the trial\n11. Not expected to survive beyond 30 days.\n12. Any current or previous medical or psychosocial condition or behaviours which in the opinion of the investigator may pose risk to the recipients or the study team\n\nExclusion Criteria:\n\n\\-","19 Years","120 Years",{"count":517,"type":22},63,[289],"The goal of this clinical trial is to learn if oral lyophilized fecal microbiota therapy (ORAL-LYO-FMT) helps treat diarrhea-predominant irritable bowel syndrome (IBS-D) and prevent the recurrence of Clostridioides difficile infection (rCDI). The main questions it aims to answer are:\n\n* Does ORAL-LYO-FMT reduce IBS symptoms?\n* Does it prevent rCDI after treatment?\n* What side effects or safety concerns might occur? Researchers will compare ORAL-LYO-FMT to a placebo (a look-alike capsule with no active treatment) to see how well it works.\n\nParticipants will:\n\n* Be randomly assigned to take ORAL-LYO-FMT or placebo for up to 7 weeks\n* Take capsules three times per week (Monday, Wednesday, Friday)\n* Complete health questionnaires and have follow-up visits by phone or in person for up to 6 months The trial also looks at changes in quality of life, mood, and new or ongoing medical conditions over time.",[521,522,523,28,524],"Irritable Bowel Syndrome, Diarrhea-Predominant (IBS-D)","Recurrent Clostridioides Difficile Infection (rCDI)","Fecal Microbiota Therapy (FMT)","Clostridioides Difficile Infection",[261,526,527,528,293,529,530,531],"Irritable bowel syndrome","rCDI","Fecal Microbiota Therapy","Gut Health","CDI","Clostridioides difficile infection, Recurrent","2025-04-21",{"date":534,"type":36},"2025-04-29",{"date":405,"type":22},{"date":537,"type":22},"2026-12",{"name":539,"class":540},"PharmaPlanter Technologies Inc","NETWORK",{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":547,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":549,"targetDuration":4,"studyType":23,"phases":551,"briefSummary":552,"conditions":553,"keywords":554,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":44},"100565812","evaluate-the-effect-of-synbiotics-in-irritable-bowel-syndrome-100565812","NCT06647043","Evaluate the Effect of Synbiotics in Irritable Bowel Syndrome","A Single-arm, Open-label Clinical Trial to Evaluate the Effect of SMT04 Pro in Irritable Bowel Syndrome (IBS)","IBSXtra02","Inclusion Criteria:\n\n* The subject must meet all of the inclusion criteria to participate in this study.\n\n  * Male or female,\n  * Aged from 18 to 70 years old\n  * Meet the criteria of the Rome-III-definition of IBS with diarrhoea or mixed subtypes, or functional diarrhoea: Rome-III-definition: Abdominal pain or abdominal discomfort on minimum of three days per month during the last three months, starting at least six months ago, and a minimum of two of the following criteria:\n\n    * Improvement of symptoms after defecation\n    * Start of symptoms in association with a change in stool frequency\n    * Start of symptoms in association with a change in stool consistency Subtype of IBS-D which requires more than 25% of your stools to be loose and less than 25% hard and lumpy; Subtype of IBS-M which your stools must be both hard and lumpy, as well as loose in consistency at least 25% of the time. Functional diarrhoea: The experience of loose or watery stools without pain occurring in at least 75% of bowel movements for at least three months over the last six months.\n  * Have the latest negative colonoscopy result within five years\n  * Literate and can complete questionnaire\n  * Written informed consent is obtained\n\nExclusion Criteria:\n\n* • Known inflammatory bowel disease, lactose intolerance or other malabsorption syndromes, celiac disease, diabetes mellitus, thyroid disfunction, cancer, immunodeficiency, autoimmune diseases, severe hepatic or renal insufficiency, other explainable causes of abdominal pain, diarrhoea or constipation\n\n  * Known operations involving small intestines and large intestines; or history of appendectomy, hysterectomy, and cholecystectomy in last 6 months\n  * Known severe mental illnesses; unstable type or dose of psychiatric drugs within the last 3 months that will affect their judgement of study participation\n  * Evidence of active infection at the time of inclusion\n  * History of use of prebiotics, probiotics, antibiotic therapy or anti-inflammatory drugs within the last 2 weeks\n  * Known current pregnancy or breast-feeding female",{"count":550,"type":22},20,[25],"Irritable Bowel Syndrome (IBS) is a brain-gut-disorder characterized by a chronic relapsing-remitting nature of symptoms, including abdominal pain and altered bowel habits. Symptoms most likely result from complex interactions between several biological, psychological and social factors.\n\nProbiotic supplements are thought to improve IBS symptoms through manipulation of the gut microbiota. Some studies have suggested that different strains of probiotics may improve abdominal pain and reduce visceral hypersensitivity by modulation of expression of neurotransmitters and receptors involved in the modulation of pain, such as the opioid receptor or the cannabinoid receptor. In addition, probiotics have been shown to reduce intestinal cytokine secretion and improve epithelial barrier function in a mice model of intestinal inflammation.\n\nBifidobacteria and Streptococci strains had previously demonstrated efficacy in achieving symptom improvement in IBS patients. Thus, there is potential for SMT04, a health supplement, to be an option for IBS patients.",[28],[28,555],"Synbiotics","2025-04-06",{"date":558,"type":36},"2025-04-09",{"date":560,"type":36},"2025-02-23",{"date":562,"type":22},"2025-09-30",{"name":564,"class":43},"Universiti Sains Malaysia",{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":4,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":227,"enrollmentInfo":572,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":573,"conditions":574,"keywords":578,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":44},"100586242","gwas-to-identify-predictive-genetic-factors-for-the-success-of-dietary-intervention-in-the-treatment-of-ibs-symptoms-100586242","NCT06912828","GWAS to Identify Predictive Genetic Factors for the Success of Dietary Intervention in the Treatment of IBS Symptoms","Whole Genome Association Study (GWAS) to Identify Predictive Genetic Factors for the Success of Dietary Intervention in the Treatment of Irritable Bowel Syndrome (IBS) Symptoms","Inclusion Criteria:\n\n* Fulfillment of the Rome IV criteria for IBS\n* Provision of written informed consent.\n* Commitment of availability throughout the study period.\n* IBS-SSS \\> 175\n\nExclusion Criteria:\n\n* Any concomitant disease requiring specialized nutrition (e.g. renal failure, diabetes, celiac disease, cerebrovascular disease of the central nervous system, major surgical cavity).\n* Pregnancy.\n* Breastfeeding.",{"count":493,"type":22},"This is a GWAS that aims to identify possible single nucleotide polymorphisms (SNPs) that are associated with the response in a combined dietary pattern low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols and Meditteranean diet (MED-LFD) in a small group of patients with Irritable Bowel Syndrome (IBS).",[28,575,576,577,177],"Genome-wide Association Study","Single Nucleotide Polymorphisms","Mediterranean Diet",[579,580],"diet response","nutrigenetics","2025-03-29",{"date":556,"type":36},{"date":584,"type":36},"2024-09-15",{"date":586,"type":22},"2027-02-15",{"name":588,"class":43},"Attikon Hospital",{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":4,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":596,"targetDuration":4,"studyType":23,"phases":598,"briefSummary":599,"conditions":600,"keywords":603,"overallStatus":268,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":610,"completionDateStruct":612,"leadSponsor":614,"locationsCount":4},"100583086","effect-of-a-low-fodmap-diet-in-ibs-and-functional-constipation-with-bloating-a-randomized-double-blind-trial-100583086","NCT06871748","Effect of a Low FODMAP Diet in IBS and Functional Constipation with Bloating: a Randomized Double-Blind Trial","Effect of a Low FODMAP Diet in Irritable Bowel Syndrome and Functional Constipation with Bloating: a Randomized Double-Blind Controlled Trial with Microbiota, Intestinal Gas, and Metabolomic Analysis","Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosed with Irritable Bowel Syndrome (IBS) or Functional Constipation (FC) based on Rome IV criteria\n* Persistent bloating affecting daily life, with a bloating VAS score ≥4\n* Stable bowel habits with Bristol Stool Form Scale (BSFS) type 3-5\n* History of prior treatment with antispasmodics and\u002For prokinetics (allowed if dose remains stable)\n* Able to comply with dietary intervention and study procedures\n\nExclusion Criteria:\n\n* Prior gastrointestinal surgery (except appendectomy or cholecystectomy)\n* Use of antibiotics, proton pump inhibitors (PPIs), probiotics, NSAIDs, lactulose, or metformin within the past 4 weeks\n* Presence of systemic diseases affecting gut microbiota (e.g., liver cirrhosis, uncontrolled diabetes, end-stage renal disease, obesity, cancer, psychiatric disorders)\n* Inability to consume study meals or follow dietary restrictions",{"count":597,"type":22},34,[25],"This clinical study aims to evaluate the effects of a low FODMAP diet compared to a high FODMAP diet in patients with Irritable Bowel Syndrome (IBS) and Functional Constipation (FC) with predominant bloating. The study is a randomized, double-blind, controlled trial designed to assess whether a diet low in fermentable carbohydrates can improve bloating symptoms, gut microbiota composition, intestinal gas production, and metabolic outputs.\n\nPatients meeting the Rome IV criteria for IBS or FC with persistent bloating will be enrolled and randomly assigned to receive either a low or high FODMAP diet for two weeks. Meals will be standardized to control FODMAPs composition, ensuring that FODMAP content is the primary variable.\n\nThe primary endpoint is the proportion of participants with a ≥30% reduction in bloating severity, measured using the Visual Analog Scale (VAS). Secondary outcomes include changes in global IBS symptoms, abdominal pain, bowel movements, stool consistency, microbiota diversity, hydrogen\u002Fmethane gas production, and metabolomic profiles.\n\nThis study will contribute to the growing body of evidence supporting dietary management in disorders of gut-brain interaction (DGBI), particularly in bloating-predominant IBS and FC, and will provide insights into the mechanisms linking diet, gut microbiota, and symptom improvement.",[28,601,602],"Constipation - Functional","Bloating",[28,604,605,606],"Functional Constipation","FODMAP","Microbiota","2025-03-06",{"date":609,"type":36},"2025-03-12",{"date":611,"type":22},"2025-03-15",{"date":613,"type":22},"2026-07-31",{"name":615,"class":43},"Mahidol University",{"id":617,"slug":618,"hasResults":12,"nctId":619,"briefTitle":620,"officialTitle":620,"acronym":4,"eligibilityCriteria":621,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":622,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":624,"conditions":625,"keywords":626,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":630,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":44},"100571543","prospective-observational-study-of-naturopathic-approaches-to-ibs-100571543","NCT06721624","Prospective Observational Study of Naturopathic Approaches to IBS","Inclusion Criteria:\n\n* Adults (≥18 years of age) who present with a pre-existing IBS diagnosis or IBS- like gastrointestinal symptoms.\n* Pre-existing IBS diagnosis or IBS-like gastrointestinal symptoms must be the primary cause of the visit.\n* An IBS diagnosis must be listed within the top 3 diagnoses for the visit and addressed in the individualized treatment plan.\n\nExclusion Criteria:\n\n\\*Inability to read and write in English.",{"count":623,"type":22},50,"Irritable bowel syndrome (IBS) is a common condition affecting about 4% of people worldwide and can significantly impact quality of life and healthcare costs. While there are medications available, few are consistently effective, leading many people with IBS to explore alternative treatments, including naturopathy. However, research on naturopathic approaches to IBS is limited.\n\nThis study aims to describe how naturopathy is used to treat IBS and to collect preliminary data on changes in IBS symptoms before and after treatment. It will use a prospective, observational design without a control group, focusing on outcomes from individualized naturopathic care provided by licensed practitioners.\n\nAdult patients with diagnosed IBS or IBS-like symptoms will be recruited from naturopathic doctors affiliated with the Gastroenterology Association of Naturopathic Physicians. Participants' IBS symptoms will be assessed using validated tools (IBS-SSS and IBS-AR), and quality of life will be measured using the PROMIS-29 survey. Treatment details and any adverse effects will also be recorded. The main outcome will be the difference in symptoms and quality of life after 12 weeks of treatment. Results will be analyzed with statistical tests (p-value \\\u003C 0.05) and summarized.\n\nThe findings from this pilot study will help fill knowledge gaps and provide a foundation for designing a more rigorous randomized controlled trial in the future.",[28],[30,261,627,628],"naturopathy","naturopathic medicine","2024-12-03",{"date":631,"type":36},"2024-12-06",{"date":633,"type":36},"2024-11-01",{"date":635,"type":22},"2025-11",{"name":637,"class":43},"National University of Natural Medicine",{"id":639,"slug":640,"hasResults":12,"nctId":641,"briefTitle":642,"officialTitle":643,"acronym":4,"eligibilityCriteria":644,"healthyVolunteers":12,"sex":17,"minAge":448,"maxAge":336,"enrollmentInfo":645,"targetDuration":4,"studyType":23,"phases":647,"briefSummary":648,"conditions":649,"keywords":651,"overallStatus":268,"whyStopped":4,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":657,"startDateStruct":658,"completionDateStruct":660,"leadSponsor":662,"locationsCount":664},"100571480","pentabiocel-in-pediatric-ibs-100571480","NCT06720805","Pentabiocel in Pediatric IBS","Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effects of a Multi-strain Probiotic in Pediatric Irritable Bowel Syndrome (PTB_IBS)","Inclusion Criteria:\n\n. IBS diagnosis (all subtypes) according to Rome IV criteria\n\n* 4 -17 years of age\n* endoscopy examination (with bioptic samples) negative for IBD or microscopic colitis\n* negative anti-transglutaminase antibodies\n* capability to follow the protocol\n* Signature of informed consent\n\nExclusion Criteria:\n\n* Presence of chronic, chromosomal, or congenital anomalies, autoimmune diseases, metabolic diseases, or immunodeficiencies.\n* Patients with concomitant conditions that may cognitively impair their understanding of study instructions and their ability to provide informed consent.\n* Current use of non-steroidal anti-inflammatory drugs, corticosteroids, and mast cell stabilizers, use of topical or systemic antibiotics in the past month, continuous use of stimulant laxatives, major abdominal surgery, inflammatory bowel disease, infectious diarrhea, allergic diseases, and other organic or psychiatric disorders.\n* Patients with concomitant organic gastrointestinal diseases (inflammatory bowel disease, celiac disease, cancer) or a major illness such as diabetes or uncontrolled thyroid disease.\n* Patients with a history of intestinal surgery (excluding appendectomy or cholecystectomy).",{"count":646,"type":22},56,[25],"Irritable Bowel Syndrome (IBS) is a common gastrointestinal disorder characterized by chronic abdominal pain and altered bowel habits, including diarrhea, constipation, or a combination of both. It is estimated to affect about 10-20% of the global population, with a higher prevalence among children and adolescents. The pathophysiology of IBS is multifactorial and involves alterations in the gut microbiota, visceral hypersensitivity, and abnormal gastrointestinal motility. Probiotics, defined as live microorganisms that provide health benefits when administered in adequate amounts, have emerged as a potential therapeutic option for IBS due to their ability to modulate the gut microbiota and exert anti-inflammatory and immunomodulatory effects.\n\nSeveral studies have shown the beneficial effects of probiotics in adult IBS patients; however, few studies have been conducted in the pediatric population.\n\nThus, the investigators designed a randomized, double-blind, placebo-controlled, parallel-arm study evaluating the efficacy and safety of a 12-week probiotic treatment with a blend of 5 strains of lactic acid bacteria and bifidobacteria in pediatric patients with Irritative Bowel syndrome.",[28,650],"Pediatrics",[28,652,653,654,655,650],"Bifidobacterium","Visceral hypersensitivity","microbiome","Lactobacillus","2024-12-02",{"date":631,"type":36},{"date":659,"type":22},"2024-12-01",{"date":661,"type":22},"2025-12-31",{"name":663,"class":43},"University of Roma La Sapienza",4,{"id":666,"slug":667,"hasResults":12,"nctId":668,"briefTitle":669,"officialTitle":670,"acronym":671,"eligibilityCriteria":672,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":673,"enrollmentInfo":674,"targetDuration":4,"studyType":23,"phases":676,"briefSummary":677,"conditions":678,"keywords":679,"overallStatus":268,"whyStopped":4,"lastUpdateSubmitDate":683,"lastUpdatePostDateStruct":684,"startDateStruct":686,"completionDateStruct":688,"leadSponsor":690,"locationsCount":4},"100570537","investigating-the-gut-microbiome-and-symptomology-in-ibs-100570537","NCT06708533","Investigating the Gut Microbiome and Symptomology in IBS","Investigating the Gut Microbiome and Symptomology in IBS: Mechanisms and Therapeutic Implications for Symptom Relief Through Prescribed Physical Activity in Clinical Practice","MICROFIT","Inclusion Criteria:\n\n* Be 18-64 years old\n* Have CLINCALLY DIAGNOSED IBS\n* Know your IBS-SUBTYPE (e.g., constipation, diarrhoea, mixed\u002Falternating)\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Organic gastrointestinal conditions (Inflammatory Bowel Disease, Coeliac Disease, Colorectal Cancer)\n* On medication with known influence on gastrointestinal motility (thyroid disease, diabetes mellitus, coeliac disease and neurological disease)\n* Have used antibiotics in the past 3 months\n* Currently using opioid pain medications (except occasional\u002Fnon-daily use of NSAIDs)\n* Regular consumption of pre- and probiotic foods\u002Fsupplements\n* Completing more than 300-minutes of PA per week","64 Years",{"count":675,"type":22},40,[25],"This intervention study explores whether a routine physical activity intervention can help manage or relieve symptoms of Irritable Bowel Syndrome (IBS) in adults who have been clinically diagnosed with IBS. The main questions it aims to answer is:\n\n• Primary Outcome: Does engaging in routine physical activity reduce the severity of IBS symptoms compared to baseline levels?\n\nComparison Group: Researchers will compare the intervention group (receiving the 12-week physical activity program) with a control group (receiving no intervention for 12-weeks).\n\nParticipant Activities and Interventions:\n\n* Complete a 12-week walking programme.\n* Visit the university on 3 occasions (baseline, week-6 and week-12) for biological sample collection and sub-maximal fitness assessments.\n* Complete a series of subjective health related questionnaires.",[28],[680,30,681,682,261],"Physical Activity","Gut Microbiome","Exercise","2024-11-25",{"date":685,"type":36},"2024-11-27",{"date":687,"type":22},"2025-03",{"date":689,"type":22},"2025-12",{"name":691,"class":43},"Nottingham Trent University"]