[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565269":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":45,"centralContacts":49,"locations":57,"responsibleParty":76,"collaborators":80,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":32,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":59,"whyStopped":32,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Duke University","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Psyllium (0.7 g\u002Fyear of age per day) given with fructans","ACTIVE_COMPARATOR","Participants will receive Psyllium (0.7 g\u002Fyear of age per day) given with fructans (daily dose 0.5 g\u002Fkg up to 19 grams)",[13,14],"Drug: Psyllium (0.7 g\u002Fyear of age per day)","Other: fructans",{"label":16,"type":10,"description":17,"interventionNames":18},"Psyllium (0.5 g\u002Fyear of age per day) given with fructans","Participants will receive Psyllium (0.5 g\u002Fyear of age per day) given with fructans (daily dose 0.5 g\u002Fkg up to 19 grams)",[19,14],"Drug: Psyllium (0.5 g\u002Fyear of age per day)",{"label":21,"type":22,"description":23,"interventionNames":24},"Placebo (0.7 g\u002Fyear of age glucose) given with fructans","PLACEBO_COMPARATOR","Participants will receive Placebo (0.7 g\u002Fyear of age glucose) given with fructans (daily dose 0.5 g\u002Fkg up to 19 grams).",[25,14],"Drug: Placebo",[27,33,37,41],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Psyllium (0.7 g\u002Fyear of age per day)","Psyllium (0.7 g\u002Fyear of age per day) (Konsyl Pharmaceuticals, Easton, MD)",[9],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Psyllium (0.5 g\u002Fyear of age per day)","Psyllium (0.5 g\u002Fyear of age per day) (Konsyl Pharmaceuticals, Easton, MD)",[16],{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"Placebo","Placebo (0.7 g\u002Fyear of age glucose) (Staleydex 333; Tate \\& Lyle, Staley, London, UK)",[21],{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":32},"fructans","Daily dose 0.5 g\u002Fkg up to 19 grams, Orafti Synergy1",[21,16,9],[46],{"name":47,"affiliation":5,"role":48},"Bruno Chumpitazi, MD, MPH","PRINCIPAL_INVESTIGATOR",[50,54],{"name":47,"role":51,"phone":52,"phoneExt":32,"email":53},"CONTACT","919-660-1227","bruno.chumpitazi@duke.edu",{"name":55,"role":51,"phone":52,"phoneExt":32,"email":56},"Annette Babu","annette.babu@duke.edu",[58],{"facility":5,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"RECRUITING","Durham","North Carolina","27705","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-78.89862,35.99403,{"lat":69,"lon":68},[72,74],{"name":55,"role":51,"phone":73,"phoneExt":32,"email":56},"9196601227",{"name":75,"role":48,"phone":32,"phoneExt":32,"email":32},"Bruno Chumpitazi",{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"SPONSOR_INVESTIGATOR","Dr Bruno Chumpitazi, M.D.","Instructor Temporary in the Department of Pediatrics, Pediatrics, Gastroenterology, Hepatology and Nutrition",[81],{"name":82,"class":83},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100565269","phase-2-psyllium-in-pediatric-ibs-100565269",false,"NCT06639984","Psyllium in Pediatric IBS","Assessing Psyllium Given With Meals for Fructan Sensitivity in Children With Irritable Bowel Syndrome","Psyllium","Inclusion Criteria:\n\n* Children between the ages of 12-17 years meeting pediatric Rome IV criteria for IBS\n\nExclusion Criteria:\n\n* Children who have had previous bowel surgery, have documented GI disorders (e.g., ulcerative colitis), or a serious chronic medical condition (e.g., diabetes)\n* weight and\u002For height are \\> or \\< 2 SD for age\n* have chronic conditions with GI symptoms (e.g., cystic fibrosis)\n* have been on antibiotics or probiotics within 3 months (because of potential alterations to the GI microbiome0\n* girls who are pregnant (tested with urine beta-human chorionic gonadotropin at the initial visit)","ALL","12 Years","17 Years",{"count":96,"type":97},110,"ESTIMATED","INTERVENTIONAL",[100],"PHASE2","The goal of this clinical trial is to learn if a fiber (psyllium) can change the way bacteria use fructans (a type of sugar) and whether psyllium can help decrease childhood irritable bowel syndrome (IBS) symptoms when eating fructans. The main questions it aims to answer are:\n\nAim 1: The effect of psyllium at two doses given with a fructan meal on microbial fructan fermentation (intracolonic pH; H2 gas production; gut microbiome composition; fecal short-chain fatty acids, lactate, glycomics).\n\nAim 2: Determine the impact of psyllium given with a fructan meal on fructan-induced GI symptoms.\n\nParticipants will first be asked to eat a specific diet over two three-day periods to determine if fructans worsen their IBS symptoms. Those with worsening symptoms with fructans will be asked to participate in the second part of the study. This includes two weeks of baseline (no change in diet) and two weeks of eating a specific diet with fructans with either psyllium or glucose. Participants will be asked to complete pain and stool diaries, submit stool specimens, swallow a pill to capture gut acid levels, and give breath samples.",[103],"Irritable Bowel Syndrome",[105],"Abdominal Pain","2026-05-21",{"date":108,"type":109},"2026-05-26","ACTUAL",{"date":111,"type":109},"2025-02-20",{"date":113,"type":97},"2027-09-30",{"name":78,"class":6},1]