[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"functional-gastrointestinal-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:functional-gastrointestinal-disorders":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,46,76,103,152,178,209,238,269,297,328,362,384,408],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100531249","gastro-intestinal-biopotential-recorder-by-means-of-surface-electrodes-100531249",false,"NCT06197334","Gastro-intestinal Biopotential Recorder by Means of Surface ELEctrodes","GRELE","Inclusion Criteria for all participants:\n\n* Person age \\> 18 years\n* Person has been fasting for at least 12 hours\n* Person who has received full information on the organization of the research and has not objected to the use of this data.\n* Person affiliated to or beneficiary of a social security plan\n* Person informed about study organization and having signed the informed consent\n\nInclusion Criteria for healthy volunteers :\n\n* Person has no history of chronic gastro-intestinal disease\n* Person has no acute of gastro-intestinal disease\n\nInclusion Criteria for Crohn's disease patients without fibrosis :\n\n* Person is already diagnosed with Crohn's disease\n* Person has underwent during the last 6 months :\n* An MRI showing no fibrosis\n* A blood test for C-reactive protein and fecal calprotectine\n* A questionnaire to asses the Harvey-Bradshaw Index\n\nInclusion Criteria for Crohn's disease patients with fibrosis :\n\n* Person is already diagnosed with Crohn's disease\n* Person has underwent during the last 6 months :\n* An MRI showing fibrosis\n* A blood test for C-reactive protein and fecal calprotectine\n* A questionnaire to asses the Harvey-Bradshaw Index\n\nInclusion Criteria for functional gastrointestinal disorders patients :\n\n* Person is already diagnosed with functional gastrointestinal disorders\n* Person has underwent an evaluation of the Rome IV criteria\n\nExclusion Criteria for all participants:\n\n* Person having a pacemaker\n* Person suffering from a sensory disorder making insensitive to pain on the skin\n* Person suffering from a mental or motor disorders creating uncontroled movements\n* Person being allergic to one or more component of the device\n* Person being allergic to : soy, dairy food, peanuts, wheat, nuts\n* Person having an history of gastro-intestinal surgery\n* Person suffering from injury or erythema on the abdominal skin\n* Person having a contagious potential (bacterial, fungal or viral)\n* Person being in menstruation period\n* Person suffering from urinary incontinence\n* Minor (not emancipated)\n* Person of legal age (subject to a legal protection measure)\n* Adult unable to give consent",true,"ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to compare the gastro-intestinal biopotentials recorded with a homemade device using surface electrodes placed on the abdomen in healthy volunteers, Crohn's disease patients without fibrosis, Crohn's disease patients with fibrosis and in functional gastrointestinal disorders (FGID) patients.\n\nThe main question it aims to answer is:\n\n• Is there any differences in the gastro-intestinal biopotentials between the different populations under study?\n\nIt aims to answer two secondary questions:\n\n* Are the gastro-intestinal biopotentials comparable to the Harvey-Bradshaw Index, MRI and biological data for patients with Crohn's disease?\n* Are the gastro-intestinal biopotentials comparable to Rome IV criteria for functional gastrointestinal disorders patients?\n\nParticipants will undertake two recordings made with the device. The first one will last 1 hour and 30 minutes and will occurs while the participants are fasting. Then, the participants will eat a standardized meal. Finally, the second recording will take place after the meal ingestion and will last 1 hour and 30 minutes while the participants are in postprandial state.",[27,28,29],"Crohn Disease","Functional Gastrointestinal Disorders","Healthy",[31,32],"Medical device","Electrophysiology","RECRUITING","2026-06-19",{"date":36,"type":37},"2026-06-24","ACTUAL",{"date":39,"type":37},"2025-02-18",{"date":41,"type":21},"2027-09-01",{"name":43,"class":44},"Central Hospital, Nancy, France","OTHER",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100585631","phase-2-safety-and-efficacy-of-crofelemer-in-adult-patients-with-short-bowel-syndrome-and-intestinal-failure-sbs-if-without-colon-in-continuity-cic-100585631","NCT06904872","Safety and Efficacy of Crofelemer in Adult Patients With Short Bowel Syndrome and Intestinal Failure (SBS-IF) Without Colon-in-continuity (CIC)","A Phase 2, Placebo-Controlled, Randomized, Double-Blind Study of 2 Doses of Crofelemer for the Treatment of Adult Patients With Short Bowel Syndrome and Intestinal Failure (SBS-IF) Without Colon-in-continuity (CIC)","CRO-SBS-IF","Inclusion Criteria\n\nPatients will be enrolled in the study if they meet all the following criteria:\n\n1. Patients must understand and provide written informed consent before they can participate in the study. They must understand the study procedures and be willing to complete the required assessments;\n2. Male and female patients aged ≥ 18 years;\n3. SBS patients with intestinal failure and without colon-in-continuity who are not eligible or not willing to receive an approved marketed GLP-2;\n4. Patients with history of SBS resulting in intestinal failure caused by a major intestinal resection (e.g., injury, cancer\\*, Crohn's disease, vascular disease, volvulus) without colon-in-continuity (patients with duodenostomy, Jejunostomy or Ileostomy). Intestinal failure will be defined according to the recommendations of the European Society for Clinical Nutrition and Metabolism (ESPEN), i.e., a reduction of gut function below the minimum necessary for the absorption of macronutrients and\u002For water and electrolytes, such that intravenous (IV) supplementation is required to maintain health and\u002For growth. \\*Patients with history of cancer, should be in remission for the last 6 months and with not ongoing anticancer therapy (long-term hormonal therapy is allowed).\n5. Minimum remaining length of 60 cm of small bowel;\n6. At least 6 months elapsed since last surgical bowel resection;\n7. No restorative surgery planned during the entire study period;\n8. Patients with at least 4 continuous months of PS dependency (parenteral nutrition with or without intravenous fluids);\n9. Chronic non-infectious diarrhoea defined as passage of at least 1 loose watery stool per day for more than 4 consecutive weeks.\n10. Patients receiving parenteral support (fluids, electrolytes and\u002For nutrients) for at least three days per week and a minimum of 6 liters of PS per week, to meet caloric, fluid or electrolytes needs;\n11. Patients with Crohn's disease will have to be in clinical remission for ≥ 12 weeks;\n12. Patients must be able to ingest solid or semi-solid foods and drink fluids;\n13. If taken at screening, use of antimotility and antidiarrheal agents (loperamide, diphenoxylate, codeine and other opiates), H2-receptor antagonists, proton pump inhibitors, bile sequestering agents, oral glutamine, diuretics and oral rehydration solutions is required to be at stable average weekly doses for at least 4 weeks prior to screening evaluations;\n14. If female and of child-bearing potential, the patient must use an \"acceptable effective contraceptive measure\" for the entire study duration and for 4 weeks after the last dose. Acceptable birth control methods that result in a failure rate of more than 1% per year include: progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action male or female condom with or without spermicide cap, diaphragm or sponge with spermicide (A combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods) are also considered acceptable). Male patients must agree to use an acceptable form of birth control and to not donate sperm during the study and for 4 weeks after the last dose.\n15. If female and child-bearing potential, the patient must have a negative urine pregnancy test prior the first administration of the investigational product;\n16. Satisfactory general health status as determined by the investigator based on current medical status, medical history and physical examination.\n\nExclusion criteria\n\nPatients cannot be enrolled in the study if they meet any of the following criteria:\n\n1. Diagnosis of celiac disease or active or refractory tropical sprue;\n2. Presence of clinically significant intestinal adhesions and\u002For chronic abdominal pain that can interfere with the conduct of the study;\n3. Patients with current radiological (Radiography and\u002For CT) evidence of bowel dilatation or pseudo-obstruction;\n4. Active Crohn's disease as evaluated by standard procedures employed by the investigator;\n5. Inflammatory bowel disease (IBD) that required immunosuppressant therapy that has been introduced or changed within last 3 months or treatment with biologics within the last 6 months;\n6. Intestinal or other major surgery scheduled within the time frame of the study;\n7. Visible blood in the stool within the last 12 weeks;\n8. Clinical evidence of active radiation enteritis or scleroderma, contributing to the patient's stool volume;\n9. Compromised immune system (e.g., acquired immune deficiency syndrome \\[AIDS\\], severe combined immunodeficiency);\n10. Inadequate hepatic function: alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) and\u002For total bilirubin and\u002For alkaline phosphatases \\> 2 times the patient's average relative values in the last 3 months;\n11. Inadequate renal function: serum creatinine or blood urea nitrogen \\> 2 times the Upper Normal Limit (UNL);\n12. Urine sodium \\\u003C20 mmol\u002Fday;\n13. More than four SBS-related hospital admissions (unless one or more admissions were to rule out line sepsis) within the past 12 months or hospital admission within the last 4 weeks;\n14. Concurrent or past use of infliximab, growth hormone or growth factors such as native glucagon-like peptide-2 (GLP-2) or other biological therapy within the last 12 weeks;\n15. Use of systemic corticosteroids, methotrexate, cyclosporine, tacrolimus, sirolimus, octreotide, intravenous glutamine within the last 4 weeks;\n16. Use of antibiotics within the last week or active infection;\n17. History of alcohol abuse (Drinking more than 12 g\u002Fday of alcohol for women and 24 g\u002Fday of alcohol for men) or drug abuse within the last year;\n18. Pregnant or lactating women;\n19. History of psychiatric illnesses which lead to consider the patient as incapacitated and prevent him\u002Fher to provide informed consent;\n20. History of any other uncontrolled chronic or acute concomitant disease which, in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results;\n21. Patient not capable of understanding or not willing to adhere to the study visit schedules and other protocol requirements;\n22. Participation in any other interventional clinical study within five times the half-life of the investigational medicinal product \u002F relevant metabolites (of the previous clinical study) or 4 weeks (whichever is longer) prior to screening;\n23. Known hypersensitivity\u002Fallergy to ANY component of the IP.",{"count":55,"type":21},18,[57],"PHASE2","A 24-week, randomized, placebo-controlled, double-blind study to evaluate the efficacy, safety and tolerability of crofelemer in patients with Short Bowel Syndrome and Intestinal Failure (SBS-IF) without colon-in-continuity (CIC) requiring parenteral support (PS).\n\nBlinded study drug will be administered orally (or enterally) three times daily (TID) as a novel crofelemer formulation, Crofelemer Powder for Oral Solution, or a matching placebo powder formulation for oral solution.\n\nPatients will be randomized in a 1:1:1 ratio to crofelemer 3 mg\u002Fkg\u002Fdose TID, crofelemer 10 mg\u002Fkg\u002Fdose TID or placebo.",[60,61,62,63,28],"Short Bowel Syndrome","Malabsorption Syndromes","Short Gut Syndrome","Post-Op Complication",[60],"2026-06-05",{"date":67,"type":37},"2026-06-09",{"date":69,"type":37},"2025-05-29",{"date":71,"type":21},"2027-03",{"name":73,"class":74},"Napo Therapeutics, S.p.A.","INDUSTRY",8,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":4},"100639300","functionally-enhanced-limosilactobacillus-reuteri-probiotic-preparation-in-elderly-patients-with-functional-bowel-disorders-100639300","NCT07624656","Functionally Enhanced Limosilactobacillus Reuteri Probiotic Preparation in Elderly Patients With Functional Bowel Disorders","An Exploratory Clinical Study on the Effects of a Functionally Enhanced Limosilactobacillus Reuteri Probiotic Preparation on Intestinal Immunity, Gut Microbiota Balance, and Intestinal Function in Elderly Patients With Functional Bowel Disorders","Inclusion Criteria:\n\n1.Diagnosis and Symptom Presentation: Participants must be diagnosed with functional gastrointestinal disorders (FGID) according to Rome IV criteria, including but not limited to:\n\n1. Functional constipation;\n2. Irritable bowel syndrome (IBS);\n3. Functional abdominal pain syndrome;\n4. Participants must have clear intestinal dysfunction-related symptoms such as abdominal pain, abdominal distension, difficulty in defecation, or changes in bowel habits, with organic gastrointestinal diseases excluded by clinical evaluation.\n\n2.Age and Disease Duration: Participants aged 50-65 years, with relevant symptoms persisting for at least 6 months, and having inadequate response to prior conventional treatment. Conventional treatments include but are not limited to: antidiarrheal agents (e.g., loperamide), gastrointestinal motility regulators (e.g., pinaverium bromide, trimebutine), intestinal microbiota products, or other commonly used drugs to improve diarrhea or regulate bowel function.\n\n3.Symptom Severity Assessment: Participants must have a total score of 10-20 on the functional bowel symptom scoring scale as specified in the study protocol (see Appendix).\n\n4.General Condition and Compliance: Participants must be able to understand the study purpose, provide written informed consent, and comply with the study procedures, including scheduled visits and collection of blood and fecal samples.\n\nExclusion Criteria:\n\n1. History or current presence of organic gastrointestinal diseases, such as gastrointestinal malignancy, inflammatory bowel disease (IBD), intestinal obstruction, or intestinal polyps.\n2. Presence of serious systemic diseases, including severe cardiovascular or cerebrovascular diseases (e.g., myocardial infarction within the past 6 months, New York Heart Association (NYHA) class III-IV heart failure, uncontrolled hypertension), significant liver or kidney dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2× upper limit of normal, estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73m²), or uncontrolled diabetes (HbA1c ≥9%).\n3. Use of antibiotics, probiotics, or other drugs significantly affecting gut microbiota within 4 weeks prior to enrollment, or anticipated need to continue these drugs during the study.\n4. Pregnant or breastfeeding women, or those planning pregnancy during the study period.\n5. Participation in other clinical trials within 3 months prior to enrollment.\n6. Any other health conditions deemed unsuitable for participation by the investigator.","50 Years","65 Years",{"count":86,"type":21},30,[24],"This is a single-center, open-label, single-arm interventional study designed to evaluate the effects of a functionally enhanced Limosilactobacillus reuteri probiotic preparation on intestinal immunity, gut microbiota balance, and intestinal function in elderly patients with functional bowel disorders. Participants aged 50-65 years with functional bowel disorders, including functional constipation, irritable bowel syndrome, or functional abdominal pain syndrome diagnosed according to Rome IV criteria, will receive the probiotic intervention.\n\nThe study will assess changes in senescence-associated secretory phenotype (SASP) expression levels to determine the extent of aging improvement, thereby evaluating the impact on intestinal immune aging. Clinical symptoms, including abdominal pain, abdominal distension, bowel movement frequency, and stool form, will also be recorded. In addition, changes in gut microbiota composition, key functional bacteria abundance, and tryptophan metabolites will be analyzed through fecal metagenomic and metabolomic approaches.\n\nSafety and tolerability will be monitored throughout the study by recording adverse events and assessing routine laboratory parameters, including blood count and serum biochemical markers. This study aims to explore the potential mechanisms by which the probiotic preparation may improve gut immune function and microbiota balance, providing evidence for future clinical applications in elderly patients with functional bowel disorders.",[28],[91,92,28],"Functionally Enhanced Limosilactobacillus reuteri","Probiotic Intervention","NOT_YET_RECRUITING","2026-06-01",{"date":96,"type":37},"2026-06-03",{"date":98,"type":21},"2026-06",{"date":100,"type":21},"2028-12",{"name":102,"class":44},"Maanshan Shiqiye Hospital",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":131,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":45},"100556807","environmental-exposure-to-heavy-metals-nanoparticles-and-emergent-contaminants-and-risk-of-allergic-diseases-100556807","NCT06529913","Environmental Exposure to Heavy Metals, Nanoparticles, and Emergent Contaminants and Risk of Allergic Diseases","Model of diseAses Related to Environmental Exposure to Heavy meTals, nanopaRticles and Emergent Contaminants, Using a dIgital platfOrm of Clinical and Bio-humoral Data: the Way to Susceptibility\u002FRisK BiomArker [MATRIOSKA Study] - The Seed.","MATRIOSKA","Inclusion Criteria:\n\n* adult subjects (over 18 years of age).\n* Subjects suffering from allergic contact dermatitis due to metals.\n* Subjects with systemic allergic syndrome due to metals.\n* Adult healthy subjects.\n* Subjects able to give written informed consent.\n\nExclusion Criteria:\n\n* Subjects under the age of 18years.\n* Pregnant\u002Fbreastfeeding women.\n* Subjects suffering from chronic renal failure requiring replacement treatment.\n* Subjects suffering from other systemic pathologies related to exposure to metals.\n* Subjects suffering from gastrointestinal diseases such as celiac disease, chronic inflammatory intestinal diseases, tumors, other skin diseases.\n* Subjects unable to express written informed consent.",{"count":112,"type":21},280,[24],"The goal of this clinical trial is to collect environmental, bio-humoral, and clinical data derived from patients with allergic contact dermatitis (ACD) and systemic metal allergic syndromes related to the exposure to heavy metals, nanoparticles, and emergent contaminants and from healthy subjects.\n\nThe main question it aims to answer is: are environmental, bio-humoral, and clinical data derived from patients with ACD and systemic metal allergic syndromes, related to the exposure to heavy metals, nanoparticles, and emergent contaminants, different from ones obtained by healthy subjects? Researchers will compare serum and urine concentration of heavy metals and nanoparticles, patch test to metals, within-breath analysis of oscillometry parameters, serum zonulin, and serum levels of protein oxidation products among patients with systemic allergic syndrome (1st study group), patients with ACD (2nd study group) and healthy subjects (3rd study group).\n\nParticipants will undergo:\n\n* measurement of exposure to heavy metals and nanoparticles including nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper, through serum and urine measurement of concentration.\n* Patch test to before mentioned metals.\n* Within-breath analysis of oscillometry parameters.\n* Measurement of serum zonulin (related to gastro-intestinal exposure).\n* Measurement of serum levels of protein oxidation products (as markers of systemic oxidative stress).",[116,117,118,119,120,121,122,28,123,124,125,126,127,128,129,130],"Allergic Contact Dermatitis","Metal Allergy","Food Allergy","Nickel Sensitivity","Nickel; Eczema","Aluminum Allergy","Chromium; Eczema","Respiratory Injury","Pollution; Exposure","Pollution Related Respiratory Disorder","Environmental Exposure","Environment Related Disease","Environmental Illness","Oxidative Stress","Risk Reduction",[117,132,133,134,135,136,137,138,139,140,116,118,28,123,126,141,142],"Nanoparticles","Emergent contaminants","Nickel","Aluminium","Copper","Chromium","Cobalt","Palladium","Titanium","Patch test","Biomarkers","2026-02-23",{"date":145,"type":37},"2026-02-24",{"date":147,"type":37},"2025-01-13",{"date":149,"type":21},"2026-12-31",{"name":151,"class":44},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":17,"minAge":159,"maxAge":18,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":175,"locationsCount":177},"100455558","auricular-vagal-nerve-stimulation-for-hypermobile-ehlers-danlos-syndrome-100455558","NCT05212129","Auricular Vagal Nerve Stimulation for Hypermobile Ehlers-Danlos Syndrome","Hypermobile Ehlers-Danlos Syndrome: Efficacy of Non-invasive Vagal Nerve Stimulation and Effects on Brain-Gut Physiology","Inclusion Criteria:\n\n* Children aged 10-18 years old\n* Children with functional upper GI complaints and clinical suspicion for hEDS or HSD as well as a Beighton score of at least 4\u002F9\n* Children with functional upper GI complaints and clinical suspicion for ANS dysfunction\n* De-identified data from our prior studies (IRB #689519 and IRB #1064187) of patients with functional GI disorders who do NOT meet criteria for hEDS will be used as a comparison group\n* Children who are English-speaking and lack other explanation for symptoms\n* Children willing to participate and consent to this study (for children, have a parent willing to participate)\n\nExclusion Criteria:\n\nA) Exclusion Criteria applying to all participants:\n\n* Medically complex children or those who take a medication or suffer from a disease that can explain symptoms will be excluded from participation in the study.\n* Adult subjects, children or their parents who have significant developmental delay (will be excluded due to difficulties in accurately completing the questionnaires and assessing symptoms)\n* Patients with findings of organic disease such as peptic ulcer disease, H.pylori gastritis, celiac disease, inflammatory bowel disease, allergic disorders, metabolic disorder or any other chronic condition or medication that may cause chronic GI symptoms will be excluded from the study.\n* Patients who are treated with a new drug affecting the central nervous system in the two weeks prior to enrollment will also be excluded.\n* Pregnancy (evaluating MD screens patients as they normally would during a clinic visit (by questioning) and would only perform urine pregnancy test if clinically indicated (absence of menstrual period or other symptoms concerning for pregnancy)\n* Chronic alcohol\u002Fillicit drug use and\u002For smoking.\n\nB) Exclusion Criteria for subjects undergoing pVNS therapy:\n\n* Severe dermatological condition or active infection of external or middle ear\n* Implanted electrical device\n\nC) Exclusion Criteria for subjects undergoing aVNS therapy:\n\n* Hearing impaired\n* Sight impaired without correction\n* Seizure disorder\n\nD) Exclusion Criteria for subjects undergoing gastric motor function sub-study:\n\n* Patients with pacemakers, metal clips used in previous surgery or other device which are not compatible with MRI scanning\n* Claustrophobia or inability to lie still in the scanner\n* Orthodontic braces or permanent retainers\n* Patients who are unable to tolerate noise produced by the MRI\n* Egg allergy or anticipated inability to complete a standardized egg meal\n\nE) Exclusion Criteria for subjects undergoing HepGI Biobank specimen collection sub-study:\n\n* Bleeding disorder for the specific biopsies\n* Recent antibiotic usage for fecal sample\n* Significant anemia or clinical status which will not allow safe blood draw required for blood collection\n* Refusal of blood collection or to provide DNA sample\n* Inability or unwillingness on the individual (or parent\u002Flegal guardian) to provide clinical or family history.","10 Years",{"count":161,"type":21},90,[24],"Hypermobile Ehlers-Danlos Syndrome (hEDS) is a connective tissue disorder characterized by hyperextensible skin, joint hypermobility and additional connective tissue manifestations. For unclear reasons, hEDS is associated with many gastrointestinal (GI) and autonomic nervous system (ANS) complaints such as postural orthostatic tachycardia syndrome (POTS). This study will address the clinical relationship between hEDS\u002FHypermobile Spectrum Disorders and autonomic regulation and see if there is a benefit of two forms of non-invasive vagal nerve stimulation therapies to reduce GI symptoms in hEDS and POTS. The study will also investigate plausible effects of these nerve stimulation therapies on gastric function and autonomic signaling.",[28,165,166,167,168],"Hypermobile Ehlers-Danlos Syndrome","Postural Orthostatic Tachycardia Syndrome","Autonomic Nervous System Disease","Autonomic Nervous System Imbalance","2026-02-11",{"date":171,"type":37},"2026-02-13",{"date":173,"type":37},"2021-04-05",{"date":149,"type":21},{"name":176,"class":44},"Medical College of Wisconsin",1,{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":16,"sex":17,"minAge":185,"maxAge":186,"enrollmentInfo":187,"targetDuration":4,"studyType":189,"phases":4,"briefSummary":190,"conditions":191,"keywords":195,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":208},"100506885","bsgm-to-evaluate-patients-with-gi-symptoms-100506885","NCT05880199","BSGM to Evaluate Patients With GI Symptoms","Body Surface Gastric Mapping (BSGM) to Evaluate Patients With Gastrointestinal (GI) Symptoms","Inclusion Criteria for Cases\n\n1. Males or females age 8 to 25 years.\n2. Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test.\n3. Confirmed diagnosis of a Functional Gastrointestinal and\u002For Motility Disorder OR undergoing one of the following procedures as part of their clinical care at one of the participating centers:\n\n   1. HRVB\n   2. PENFS\n   3. ADM\n   4. Colonic Manometry\n   5. Pyloric Botox\n   6. Pyloric Dilation\n   7. Gastric Scintigraphy\n   8. GES\n   9. gammaCore\n4. Those with a body mass index of \\\u003C 35.\n5. Parental\u002Fguardian permission (informed consent) and if appropriate, child assent.\n\nExclusion Criteria for Cases\n\n1. History of skin allergies or a history of extreme sensitivity to cosmetics or lotions. Currently open wounds, abrasions, infected or inflamed abdominal skin. (Please note, majority of feeding tubes can be accommodated by the array placement.)\n2. Pregnant women.\n3. Those with any condition, where fasting is not recommended by a physician.\n4. Any allergies to foods that may be present in the standardized meal that cannot be accommodated with an acceptable substitute meal.\n5. Those with physical limitations, who are not able to maintain a relaxed reclined position for the study visit duration.\n6. Those with major developmental delay or cognitive impairment, who are not able to report their symptoms\u002Ffeelings in the questionnaires.\n7. Those with GI motility disorders that are limited in the esophagus, and the gastric mapping is restricted to capture relevant data based on the investigator's discretion.\n8. Parents\u002Fguardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.\n\nInclusion Criteria for Controls\n\n1. Males or females age 8 to 25 years.\n2. Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test.\n3. Do not have an active Functional Gastrointestinal disorder (FGID) diagnosis and will not be undergoing any procedures outlined in the recruitment plan in the near future.\n4. Those with a body mass index of \\\u003C 35.\n5. Individuals may include siblings of those with FGIDs.\n6. Parental\u002Fguardian permission (informed consent) and if appropriate, child assent.\n\nExclusion Criteria for Controls\n\n1. History of skin allergies or a history of extreme sensitivity to cosmetics or lotions. Currently open wounds, abrasions, infected or inflamed abdominal skin.\n2. Pregnant women.\n3. Those with any condition, where fasting is not recommended by a physician.\n4. Allergies to foods that may be included in the standardized meal that cannot be accommodated with an acceptable substitute meal.\n5. Those with physical limitations, who are not able to maintain a relaxed reclined position for the study duration.\n6. Those with major developmental delay or cognitive impairment, who are not able to report their symptoms\u002Ffeelings in the questionnaires.\n7. Those with GI motility disorders that are limited in the esophagus, and the gastric mapping is restricted to capture relevant data based on the investigator's discretion.\n8. Parents\u002Fguardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.","8 Years","25 Years",{"count":188,"type":21},685,"OBSERVATIONAL","The goal of this observational study is to learn about gastric myoelectric activity in children with GI symptoms. The main question it aims to answer is which patterns or signals are associated with GI symptoms as measured by a body surface gastric mapping (BSGM) device. Participants will have their stomach activity recorded for up to 4 hours using the BSGM device and log real-time symptoms. Researchers will compare the recordings of healthy children and children with GI symptoms to define abnormal GI patterns.",[192,28,193,194],"Gastrointestinal Motility Disorders in Children","Gastroparesis","Dyspepsia and Other Specified Disorders of Function of Stomach",[196,197,198],"GI motility","gastroparesis","functional dyspepsia","2026-02-06",{"date":201,"type":37},"2026-02-10",{"date":203,"type":37},"2021-10-01",{"date":205,"type":21},"2028-06-30",{"name":207,"class":44},"Children's Hospital of Philadelphia",5,{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":16,"sex":17,"minAge":217,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":22,"phases":221,"briefSummary":222,"conditions":223,"keywords":224,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":177},"100497171","effect-of-fecal-microbiota-transplantation-fmt-in-pediatric-functional-gastrointestinal-disorders-100497171","NCT05753774","Effect of Fecal Microbiota Transplantation (FMT) in Pediatric Functional Gastrointestinal Disorders","Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Functional Gastrointestinal Disorders in Children","FGIDs","Inclusion Criteria:\n\n* The diagnosis and classification of patients with FGIDs were in accordance with the ROME IV criteria for children\n\nExclusion Criteria:\n\n* organic gastrointestinal disease (as established by medical history, blood routine, biochemistry, c-reaction protein, erythrocyte sedimentation rate, and fecal routine examinations.)\n* other chronic disease\n* growth failure","1 Year","15 Years",{"count":220,"type":21},100,[24],"Safety and efficacy of FMT in Pediatric Functional Gastrointestinal Disorders",[28],[225,226,227,228],"Functional Gastrointestinal Disorders;","FMT;","Safety; efficacy","efficacy","2025-09-03",{"date":231,"type":37},"2025-09-10",{"date":233,"type":37},"2022-08-01",{"date":235,"type":21},"2026-08-01",{"name":237,"class":44},"Biao Zou",{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":16,"sex":17,"minAge":246,"maxAge":217,"enrollmentInfo":247,"targetDuration":4,"studyType":22,"phases":249,"briefSummary":250,"conditions":251,"keywords":253,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":177},"100539850","prevalence-of-fgids-and-probiotics-study-100539850","NCT06309199","Prevalence of FGIDs and Probiotics Study","Center of Excellence in Thai Pediatric Gastroenterology, Hepatology and Immunology","PROOF","Inclusion Criteria:\n\n1. Healthy and term (GA 37-41 weeks) infants\n2. Appropriate weight for age\n3. APGAR score more than 8 at 10 minutes of life\n4. Normal physical examination\n5. Mothers have no previous probiotics use\n\nExclusion Criteria:\n\n1. not willing to anticipate in the study\n2. cannot come to follow-up until 1 year of age","3 Days",{"count":248,"type":21},512,[24],"This is a study to evaluate the prevalence of FGIDs in infants using the Thai version of Rome IV diagnostic questionnaire for functional gastrointestinal disorders in infants and evaluate the efficacy of Limosilactobacillus reuteri DSM 17938 to prevent FGIDs in infants.",[28,252],"Infant Conditions",[254,255,256,257,258,259],"functional gastrointestinal disorder","colic","regurgitation","constipation","infant","prevalence","2025-06-28",{"date":262,"type":37},"2025-07-02",{"date":264,"type":37},"2024-03-14",{"date":266,"type":21},"2026-02",{"name":268,"class":44},"Chulalongkorn University",{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":17,"minAge":277,"maxAge":278,"enrollmentInfo":279,"targetDuration":4,"studyType":189,"phases":4,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":177},"100518475","prevalence-and-natural-history-of-functional-gastrointestinal-disorders-among-at-risk-infants-100518475","NCT06031025","Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants.","Prospective Assessment of the Prevalence and Natural History of Gastroesophageal Reflux and Functional Gastro-intestinal Disorders Among At-risk Infants","FUSID","Inclusion Criteria:\n\n* infants with gestational age at birth \\\u003C 31 weeks\n* infants with gestational age at birth \\\u003C 37 weeks and major respiratory or neurologic morbidity\n* infants with history of perinatal asphyxia\n\nExclusion Criteria:\n\n* lack of informed consent\n* diagnosis of congenital or other major gastrointestinal disease (i.e. inflammatory bowel disease, cancer)","3 Months","24 Months",{"count":280,"type":21},71,"The goal of this observational study is to learn about the prevalence and characteristics of functional gastrointestinal disorders (FGID) in at risk infants (former preterm infants and those with birth asphyxia) during the first 2 years of life. The main questions it aims to answer are:\n\n* evaluate the prevalence of symptoms related to gastro-esophageal reflux (GER), of functional gastrointestinal disorders during the first 2 years of life\n* describe growth parameters during follow-up up to the corrected age of 2 years Participants will be assessed clinically and with a structured questionnaire based on the Rome IV criteria to describe FGID.",[28,283,284,285,286,287,288],"Gastroesophageal Reflux","Constipation - Functional","Diarrhea","Dyschezia","Colic, Infantile","Vomiting; Cyclical","2025-03-10",{"date":291,"type":37},"2025-03-11",{"date":293,"type":37},"2022-05-20",{"date":295,"type":21},"2025-09-30",{"name":151,"class":44},{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":304,"enrollmentInfo":305,"targetDuration":4,"studyType":22,"phases":307,"briefSummary":308,"conditions":309,"keywords":310,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":327},"100553606","evolution-of-functional-gastrointestinal-disorders-in-infants-fed-with-a-new-infant-formula-100553606","NCT06488274","Evolution of Functional Gastrointestinal Disorders in Infants Fed With a New Infant Formula","Assessment of the Evolution of functIonal Gastrointestinal Disorders in Infants During Their Dietary Management With a New Infant Formula","Inclusion Criteria:\n\n1. Infants presenting with at least one of the FGIDs below, defined based on adapted Rome IV criteria as follows:\n\n   1.1 Regurgitations: 1.2 Colic: 1.3 Constipation:\n2. Infants born at 35 weeks or more of gestational age\n3. Infants up to 4 months of age\n\nExclusion Criteria:\n\n1. Exclusively or partially breastfed infants (i.e. \\> 2 breast feeds per day) with maternal willingness to continue breastfeeding\n2. Diversified infants or whose parents intend to start diversification within the first 2 weeks of the study\n3. Use of antibiotics at inclusion visit (V0) and within 7 days before the inclusion visit (V0)\n4. The willingness to take additional pre-, probiotics or thickening agents during the study\n5. Known allergy\u002Fintolerance to any of the product ingredients or suspected allergy to cow's milk requiring an eviction diet\n6. Infants presenting with any other situation including the participation in another clinical trial, which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the patient\n\n(non exhaustive list)","4 Months",{"count":306,"type":21},139,[24],"This study aims to assess the evolution of functional gastrointestinal disorders (FGIDs) in infants fed with a new infant formula, using the Gastrointestinal (GI) and gastroesophageal reflux (GER) (GIGER) scale through an interventional, open-label, non-comparative multicenter study.",[28],[311,312,313,314,315,316,317],"Regurgitations","Colic","Constipation","Infant formula","GIGER scale","Nutrition","Infants","2025-01-02",{"date":320,"type":37},"2025-01-06",{"date":322,"type":37},"2024-10-21",{"date":324,"type":21},"2026-04",{"name":326,"class":74},"United Pharmaceuticals",4,{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":16,"sex":17,"minAge":336,"maxAge":18,"enrollmentInfo":337,"targetDuration":4,"studyType":22,"phases":339,"briefSummary":341,"conditions":342,"keywords":345,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":177},"100536756","phase-1-exploring-treatments-for-childrens-abdominal-pain-comparing-trimebutine-and-probiotics-100536756","NCT06268964","Exploring Treatments for Children's Abdominal Pain: Comparing Trimebutine and Probiotics","Comparative Effect of Trimebutine and Probiotics on Functional Abdominal Pain Disorders (FAPD) in Children: Randomized Clinical Trial (RCT)","FAPD_RCT","Inclusion Criteria:\n\n* Pediatric patients from 4 to 18 years old.\n* Meeting the Rome IV criteria for any of the Functional Abdominal Pain Disorders (Functional Dyspepsia, Irritable Bowel Syndrome, Abdominal Migraine or Functional Abdominal Pain Not Otherwise Specified)\n* Having the informed consent signed by the parents or legal guardians of the minor.\n\nExclusion Criteria:\n\n* Patients presenting abdominal pain of organic cause.\n* Immunosuppressed patients.\n* Patients with previous hypersensitivity to the study drug.\n\nElimination Criteria:\n\n* Voluntary withdrawal from the study.\n* Patients not adhering to treatment (less than 80%)\n* Patients participating in another study simultaneously.\n* Patients being treated by another doctor simultaneously.","4 Years",{"count":338,"type":21},82,[340,57],"PHASE1","The goal of this clinical trial is to test the effectiveness of trimebutine and probiotics in treating Functional Abdominal Pain Disorders (FAPD) in a pediatric population. The main questions it aims to answer are: Is trimebutine effective in reducing the symptoms of FAPD in children? Are probiotics effective in reducing the symptoms of FAPD in children? Participants will be randomly assigned to one of three treatment groups (trimebutine\u002Fprobiotics, probiotics\u002Fplacebo, or trimebutine\u002Fplacebo). Undergo measurements for pain and other relevant metrics at the start of the study, after 4 weeks, and after 8 weeks.\n\nResearchers will compare the trimebutine\u002Fprobiotics group to the probiotics\u002Fplacebo and the trimebutine\u002Fplacebo groups to see if there are significant differences in the efficacy of these treatments in reducing symptoms of FAPD in children.",[343,28,344],"Functional Abdominal Pain Syndrome","Irritable Bowel Syndrome Variant of Childhood",[346,347,348,349,350,351,352],"functional abdominal pain","randomized clinical trial","placebo","double-blind","trimebutine","Lactobacillus rhamnosus","pediatrics","2024-08-13",{"date":355,"type":37},"2024-08-16",{"date":357,"type":21},"2024-09-01",{"date":359,"type":21},"2025-06-30",{"name":361,"class":44},"Universidad de Colima",{"id":363,"slug":364,"hasResults":11,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":368,"eligibilityCriteria":369,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":370,"enrollmentInfo":371,"targetDuration":4,"studyType":22,"phases":372,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":177},"100503228","low-fodmap-diet-in-fd-pds-100503228","NCT05832528","Low FODMAP Diet in FD (PDS)","The Effect of a Low FODMAP Diet in Functional Dyspepsia Patients With Meal Related Symptoms on Complaint Pattern and Urinary Histamine Excretion","FFDU","Inclusion Criteria:\n\n1. Patients with Functional dyspepsia\u002F postprandial distress syndrome as per Rome IV diagnostic criteria\n\n   * Symptom characteristics of dyspepsia (upper gastrointestinal symptoms occurring in the last 6 months and meal related (PDS))\n   * Negative endoscopy (maximum 12 months old)\n2. Patients must provide witnessed written informed consent prior to any study procedures being performed\n3. Patients aged between 18 and 70 years inclusive\n4. Male or female patients\n\nExclusion Criteria:\n\n1. Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study\n2. Patients with any major psychiatric disorders (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years\n3. Patients presenting with predominant symptoms of irritable bowel syndrome (IBS) and of gastro-oesophageal reflux disease (GERD)\n4. Patients who changed their diet over the last 3 months or have previously tried the low FODMAP diet are excluded from the study.\n5. Females who are pregnant or lactating are excluded from the study.","70 Years",{"count":86,"type":21},[24],"The goal of this dietary intervention study is to assess the efficacy and mechanisms of a low-FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) diet in functional dyspepsia patients. The main questions it aims to answer are:\n\n* If a low-FODMAP diet can reduce dyspeptic complaints\n* How a low-FODMAP diet can reduce dyspeptic complaints in functional dyspepsia (FD).\n\nParticipants will follow a 6-week during low-FODMAP diet followed by powder reintroduction of 6 FODMAPs and 1 control substance.",[28],"2024-06-28",{"date":377,"type":37},"2024-07-01",{"date":379,"type":37},"2022-10-03",{"date":381,"type":21},"2025-02-15",{"name":383,"class":44},"Universitaire Ziekenhuizen KU Leuven",{"id":385,"slug":386,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":370,"enrollmentInfo":390,"targetDuration":4,"studyType":189,"phases":4,"briefSummary":392,"conditions":393,"keywords":396,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":177},"100532624","capsule-microbiota-sampling-in-ibsfunctional-gastrointestinal-disease-100532624","NCT06215222","Capsule Microbiota Sampling in IBS\u002FFunctional Gastrointestinal Disease","Inclusion Criteria:\n\n* Males or females 18 years of age or older and 70 years of age or younger at the time of the first Screening Visit.\n* American Society of Anesthesiologists (ASA) Physical Status Classification System 1 or 2 (1-A normal healthy patient or 2-A patient with mild systemic disease)\n* For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit. Willingness to use highly effective contraception during the entire study period (e.g.: implants, injectables, oral contraceptives, intra-uterine device or declared abstinence).\n* Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form.\n* Positive for at least one clinical symptoms consistent with SIBO and or IBS and or a Rome Diagnosis of functional GI disorder (Rome IV criteria)\n\nExclusion Criteria:\n\n* History of any of the following:\n\n  * Prior gastric or esophageal surgery, including lap banding or bariatric surgery\n  * Bowel obstruction\n  * Gastric outlet obstruction\n  * Diverticulitis\n  * Inflammatory bowel disease\n  * Ileostomy or colostomy\n  * Gastric or esophageal cancer\n  * Achalasia\n  * Esophageal diverticulum\n* Active Dysphagia or Odynophagia\n* Active medication use for any gastrointestinal conditions\n* Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding\n* Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the investigator, to interfere with the conduct of the study",{"count":391,"type":21},40,"We will sample intestinal microbiota using a microbiome sampling capsule in Healthy, Irritable Bowel Syndrome (IBS), and Functional Gastrointestinal Disease.",[394,29,395,28],"IBS - Irritable Bowel Syndrome","Functional Bloating",[397,398],"microbiome","Small intestine","2024-01-10",{"date":401,"type":37},"2024-01-22",{"date":403,"type":37},"2023-11-16",{"date":405,"type":21},"2026-12-01",{"name":407,"class":44},"Stanford University",{"id":409,"slug":410,"hasResults":11,"nctId":411,"briefTitle":412,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":414,"enrollmentInfo":415,"targetDuration":4,"studyType":22,"phases":417,"briefSummary":418,"conditions":419,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":4},"100451485","sucrase-isomaltase-deficiency-as-a-cause-of-irritable-bowel-syndrome-100451485","NCT05159115","Sucrase-isomaltase Deficiency as a Cause of Irritable Bowel Syndrome","Validation of the 13C-labelled breath test to diagnose sucrase-isomaltase deficiency (n=40)\n\nInclusion Criteria:\n\n* Signed informed consent\n* BMI 18-30 kg\u002Fm2\n* Referred for gastroscopic examination with suspected GI disorder\n\nExclusion Criteria:\n\n• Unwilling or not capable of signing the informed consent\n\nSucrase-isomaltase deficiency as a cause of symptoms in patients with irritable bowel syndrome (n=80)\n\nInclusion Criteria:\n\n* Signed informed consent\n* BMI 18-30 kg\u002Fm2\n* IBS diagnosis according to Rome IV criteria\n\nExclusion Criteria:\n\n* Inflammatory bowel disease, celiac disease or diabetes mellitus\n* Chronic immune diseases affecting the GI-system\n* Unwilling\u002Funable to maintain a stable diet throughout the study period\n* Use of antibiotic treatment for the last 4 weeks\n* Currently on a restrictive diet","90 Years",{"count":416,"type":21},80,[24],"Irritable bowel syndrome (IBS) is a functional disorder causing troublesome symptoms and reduced quality of life. It affects 10-20% of the population, hence creates large costs for society. About 30-40% of all IBS patients do not benefit from current treatment options. Sucrase-isomaltase (SI) deficiency is an unexplored condition, that may explain symptoms in IBS patients who experience no effect from today's treatments. Currently, a duodenal biopsy is the gold standard for the diagnosis of SI deficiency, however the condition is not well investigated. A 13C-labelled breath test holds promise as a non-invasive alternative, but it has not previously been validated.\n\nThis project will address the knowledge gap related to a possible association between SI deficiency and IBS by addressing two research questions that have never been answered before. We aim to:\n\n1. Validate the 13C-labelled breath test as a diagnostic tool by assessing the strength of the association between the breath test and SI activity measured in duodenal biopsies\n2. Use the 13C-labelled breath test in a randomized dietary crossover trial comparing a starch and sucrose reduced diet (SSRD) with the standard low-FODMAP diet in IBS patients, to evaluate whether SI activity is associated with dietary changes according to symptom severity and gut microbiota composition",[420,421,422,423,28],"Irritable Bowel Syndrome","Sucrose Intolerance Due to Sucrase-Isomaltase Deficiency","Carbohydrate; Malabsorption","Sucrase Isomaltase Deficiency","2022-01-18",{"date":426,"type":37},"2022-02-02",{"date":428,"type":21},"2022-03-14",{"date":430,"type":21},"2027-12-31",{"name":432,"class":44},"Lovisenberg Diakonale Hospital"]