[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"functional-gastrointestinal-disorders-fgids\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:functional-gastrointestinal-disorders-fgids":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,79,108,139],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100592960","mechanism-of-fodmap-restriction-on-fgid-patients-100592960",false,"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)","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","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",[27,28,29],"Functional Gastrointestinal Disorders (FGIDs)","Irritable Bowel Syndrome (IBS)","Functional Dyspepsia",[31,32,29,33,34],"Functional Gastrointestinal Disorder","Irritable Bowel Syndrome","FODMAP Restriction","Gentle FODMAP","RECRUITING","2026-05-08",{"date":38,"type":39},"2026-05-11","ACTUAL",{"date":41,"type":39},"2025-07-20",{"date":43,"type":21},"2026-09-30",{"name":45,"class":46},"Universiti Kebangsaan Malaysia Medical Centre","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":57,"maxAge":18,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":47},"100582430","autonomic-reactivity-and-personalized-neurostimulation-100582430","NCT06863207","Autonomic Reactivity and Personalized Neurostimulation","Autonomic Reactivity to Restore a Dysregulated Brain-Gut Axis Via Targeted Therapy","Inclusion Criteria:\n\n* 11 to 18 years of age\n* English speaking\n* meeting Rome IV diagnostic criteria for cyclic vomiting syndrome or functional dyspepsia and willingness to participate and consent\u002Fassent to the study\n* All subjects will have a constellation of chronic symptoms indicative of autonomic dysfunction for minimum 3 months: postural dizziness\u002Flightheadedness, syncope, palpitations, fatigue, sleep disturbance, thermoregulatory abnormalities and cognitive impairment with upright position +\u002F- abnormal autonomic testing if performed per standard of care as per American Autonomic Society consensus criteria.\n\nExclusion Criteria:\n\n* Presence of organic disease that may explain symptoms\n* Requirement for parenteral nutrition\n* Developmental delays precluding accurate symptom report\n* Severe dermatological condition or active infection of external or middle ear\n* Implanted electrical device\n* Severe mental health disorder not controlled by therapy (schizophrenia, bipolar disease, severe depression, post-traumatic distress disorder) and\u002For psychotic features which could influence symptom report or ANS measurements and result in adverse reactions to hypnosis therapy",true,"FEMALE","11 Years",{"count":59,"type":21},120,[24],"Disorders of gut-brain interaction (DGBI) affect up to 25% of U.S. children. Patients often suffer from disabling, multisystem comorbidities that suggest a common root (sleep disturbances, fatigue, anxiety, etc). Yet, DGBI are defined and treated based on GI symptom origin (cyclic vomiting, dyspepsia, irritable bowel) rather than underlying pathophysiology. Many patients manifest comorbidities suggesting an underlying autonomic nervous system (ANS) dysregulation (palpitations, dizziness, cognitive dysfunction). Unfortunately, due to common features of anxiety and visceral hyperreactivity and lack of obvious pathology, children with DGBI are frequently diagnosed with psychosomatic or 'benign, functional disorders' and treated with empiric antidepressants despite lack of scientific support and risks of serious side effects. Little is known about the underlying brain-gut mechanisms linking these comorbidities. A lack of targeted treatment options naturally follows the paucity of mechanistic data. A dysregulated ANS response circuit via brainstem nuclei is linked to visceral hypersensitivity. As the team's prior research has shown, ANS regulation can be non-invasively measured via several validated indices of cardiac vagal tone. Using the novel vagal efficiency (VE) metric, the investigators have demonstrated inefficient vagal regulation in cyclic vomiting syndrome and pain-related DGBI and that low VE predicts response to non-invasive, auricular percutaneous electrical nerve field stimulation (PENFS) therapy. PENFS targets brainstem vagal afferent pathways and, along with brain-gut interventions such as hypnotherapy, are the only therapies currently proven effective for pediatric DGBI. Individualizing neurostimulation based on sensory thresholds while assessing dynamic ANS reactivity offers a path towards personalized medicine using the most effective therapies to date. This proposal will test the feasibility of an ANS tracking software in assessing real-time, autonomic regulation and providing individualized neurostimulation in children with nausea\u002Fvomiting and ANS imbalance.",[27,63,29,64],"Cyclic Vomiting Syndrome","Dysautonomia",[66,67,68,69],"autonomic dysfunction","auricular neurostimulation","gastric motor function","gut-directed hypnotherapy","2026-02-11",{"date":72,"type":39},"2026-02-13",{"date":74,"type":39},"2025-01-24",{"date":76,"type":21},"2029-06",{"name":78,"class":46},"Medical College of Wisconsin",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":55,"sex":17,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":103,"leadSponsor":105,"locationsCount":47},"100617566","effects-of-multi-strain-bacillus-spore-probiotics-on-growth-digestive-function-and-gut-microbiota-in-cesarean-delivered-neonates-100617566","NCT07320287","Effects of Multi-strain Bacillus Spore Probiotics on Growth, Digestive Function, and Gut Microbiota in Cesarean-Delivered Neonates","A Randomized, Blinded, Controlled Trial to Evaluate Effects of Multi-strain Bacillus Spore Probiotic Supplements (LiveSpo PREG-MOM and LiveSpo CONSY) on Growth Metrics, Prevention of Functional Gastrointestinal Disorders, and Modulation of the Gut Microbiota in Cesarean-Delivered Neonates","Inclusion Criteria:\n\n* Healthy term neonates delivered by cesarean section.\n* Infants were born at term, ranging from 38 to 40 weeks' gestation.\n* Birth weight appropriate for gestational age (AGA), defined as between the 10th and 90th percentiles for gestational age (≥P10 and ≤P90).\n* The infant's parent(s) or legal guardian(s) provide written informed consent and agree to comply with study procedures.\n\nExclusion Criteria:\n\nFor the neonate:\n\n* Multiple births (twins, triplets, etc.)\n* Birth weight outside the appropriate-for-gestational-age range: small for gestational age (SGA, \\\u003C P10) or large for gestational age (LGA, \\> P90).\n* Major congenital abnormalities affecting the hematologic, hepatobiliary, cardiovascular, renal\u002Furinary, or gastrointestinal systems; severe inborn errors of metabolism; or suspected primary immunodeficiency.\n* Prior exposure to systemic or enteral antibiotics (oral, IV, or IM) before the baseline assessment.\n* Known allergy or intolerance to any component of the investigational product.\n* Concurrent participation in another interventional clinical trial.\n* The investigators judge the neonate to be unsuitable for participation.\n* Parent(s) or legal guardian(s) who do not comply with study requirements or refuse to sign the informed consent.\n\nFor the mother:\n\n* Mother diagnosed with a serious or unstable medical condition involving the hepatobiliary, renal\u002Furinary, cardiovascular, respiratory, endocrine\u002Fmetabolic, or psychiatric systems.\n* Mother who intends to use, or is prescribed, any other probiotic\u002Fprebiotic product for herself or the infant during the study period.","0 Days","1 Day",{"count":89,"type":21},180,[24],"Infants born by cesarean section commonly show early weight loss and slower recovery of birth weight, together with characteristic patterns of gut microbiota dysbiosis marked by reduced Bifidobacterium and Bacteroides and increased Proteobacteria. This early microbial alteration has been associated with functional gastrointestinal disorders (FGIDs), including colic, regurgitation, and changes in stool frequency and consistency, which may in turn affect early growth and overall gastrointestinal functioning. Probiotic supplementation is considered a safe and feasible strategy to support microbial restoration and improve digestive function during the first months of life.\n\nIn this study, researchers propose that daily supplementation with multi-strain Bacillus spore probiotics may help support healthy early growth, reduce functional gastrointestinal symptoms, and promote a more balanced gut microbiota in cesarean-delivered infants.\n\nThe objective of this study is to evaluate the safety and efficacy of two oral probiotic formulations, LiveSpo PREG-MOM and LiveSpo CONSY, containing multi-strain B. subtilis ANA46, B. clausii ANA39, and B. coagulans ANA40 at respective 3 and 4 billion colony-forming units (CFU)\u002F5 mL ampoule, administered 1 ampoule daily, during the first 90 days of life. The study examines effects on growth, digestive symptoms, immune markers, and microbial composition.\n\nStudy Design: This randomized, blind, controlled clinical trial will enroll 180 healthy full-term cesarean-born infants at Hanoi Obstetrics and Gynecology Hospital.\n\nIntervention Description: Participants will be randomly assigned to three groups (n = 60 each). All groups will receive one 5-mL ampoule daily for 90 days: LiveSpo PREG-MOM, LiveSpo CONSY, or placebo. Stool samples will be collected at several follow-up time points to assess digestive health and microbial development. All products will be provided in blinded and coded packaging to maintain objectivity.\n\nStudy Duration: 12 months",[27,93],"Weight Loss",[95,96,97],"Cesarean-born Infants","Gut Dysbiosis","Bacillus spore","NOT_YET_RECRUITING","2026-01-06",{"date":101,"type":39},"2026-01-07",{"date":101,"type":21},{"date":104,"type":21},"2027-01-07",{"name":106,"class":107},"Anabio R&D","INDUSTRY",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":126,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":138},"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":118,"type":21},36,[24],"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.",[122,28,27,123,124,125,29],"Functional Abdominal Pain Disorders","Gastrointestinal and Digestive Disorder","Abdominal Pain\u002F Discomfort","Pain",[127,128],"abdominal pain","irritable bowel syndrome","2025-10-28",{"date":131,"type":39},"2025-10-30",{"date":133,"type":21},"2025-12-01",{"date":135,"type":21},"2026-11-30",{"name":137,"class":46},"Baylor College of Medicine",2,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":55,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":47},"100568886","a-heart-rate-variability-hrv-biofeedback-training-in-functional-gastrointestinal-disorders-fgid-100568886","NCT06687057","A Heart Rate Variability (HRV) Biofeedback Training in Functional Gastrointestinal Disorders (FGID)","A Heart Rate Variability (HRV) Biofeedback Training to Reduce Symptomatology Associated With Functional Gastrointestinal Disorders (FGID) in College Students.","BF_FDGI","Inclusion Criteria:\n\n* presence of clinically significant anxiety symptoms (DASS-21 \\> 4)\n* presence of symptoms related to Functional Gastrointestinal Disorders (in English, known as Functional Gastrointestinal Disorders (FGIDs)) (IBS-SSS \\> 75);\n* obtaining informed consent to participate in the study;\n* Absence of organic gastrointestinal diseases: thus, they will be excluded if with a current or previous diagnosis of intestinal disease (e.g., ulcerative colitis);\n* absence of clinical conditions including neurological disorders (previous head trauma, degenerative neurological disorders, stroke, etc.) and cardiovascular disorders (hypertension, cardiac arrhythmias, etc.).\n\nExclusion Criteria:\n\n* absence of clinically significant anxiety symptoms (DASS-21\\\u003C 4);\n* absence of symptoms related to Functional Gastrointestinal Disorders (in English, known as Functional Gastrointestinal Disorders (FGIDs)) (IBS-SSS \\\u003C 75);\n* lack of obtaining Informed Consent to participate in the study;\n* presence of organic gastrointestinal diseases: therefore, they will be excluded if with a current or previous diagnosis of intestinal disease (e.g., ulcerative colitis).\n* presence of clinical conditions including neurological disorders (previous head trauma, degenerative neurological disorders, stroke, etc.) and cardiovascular disorders (hypertension, cardiac arrhythmias, etc.).",{"count":148,"type":21},40,[24],"Functional Gastrointestinal Disorders (FGIDs) are conditions characterized by chronic gastrointestinal symptoms without evidence of pathology. These disorders are believed to result from alterations in gut-brain communication. The most common subtypes are Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), often accompanied by chronic pain, anxiety, and depression. The role of stress in the manifestation of FGIDs is notable, with stress-related distress affecting the nerve pathways that connect gut and brain. Recent interest has focused on the use of Heart Rate Biofeedback (HRV). High levels of stress are associated with reduced HRV, which is common in patients with FGID. HRV biofeedback has been shown to be effective in improving parasympathetic tone and reducing sympathetic tone. The present study aims to evaluate the effectiveness of this approach in reducing stress and symptoms associated with FGIDs in college students.\n\nThe project involves online screening to recruit participants, who will then be randomized to receive either the true HRV biofeedback treatment or a placebo condition. Pre- and post-treatment assessments include psychological questionnaires, physiological recordings, and a three-month follow-up. The treatment is expected to improve HRV, thereby reducing anxiety and gastrointestinal symptoms.",[27],"2025-08-19",{"date":154,"type":39},"2025-08-24",{"date":156,"type":39},"2024-12-01",{"date":158,"type":21},"2026-01-31",{"name":160,"class":46},"Fondazione Don Carlo Gnocchi Onlus"]