[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583086":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":39,"locations":24,"responsibleParty":47,"collaborators":24,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":24,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":24,"enrollmentInfo":59,"targetDuration":24,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":74,"whyStopped":24,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":24},{"fullName":5,"class":6},"Mahidol University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Low FODMAP Diet","EXPERIMENTAL","Participants will follow a low FODMAP diet for two weeks, consuming standardized meals with minimal fermentable carbohydrates. Meals match the high FODMAP diet in appearance to maintain blinding.",[13],"Other: Low FODMAP Diet",{"label":15,"type":16,"description":17,"interventionNames":18},"High FODMAP Diet","ACTIVE_COMPARATOR","Participants will follow a high FODMAP diet for two weeks, consuming standardized meals with high fermentable carbohydrates. Meals match the low FODMAP diet in appearance to maintain blinding.",[19],"Other: High FODMAP Diet",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"A standardized diet containing low levels of fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs), designed to reduce bloating and gastrointestinal symptoms. Meals are pre-prepared, calorie-matched, and visually identical to those in the high FODMAP group to maintain blinding. Participants will consume three main meals and one snack daily for two weeks, with adherence monitored through food diaries and photos.",[9],null,{"type":6,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"A standardized diet containing high levels of fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) to assess its impact on bloating and gastrointestinal symptoms. Meals are calorie-matched and visually identical to those in the low FODMAP group to maintain blinding. Participants will consume three main meals and one snack daily for two weeks, with adherence tracked through food diaries and photos.",[15],[29,33,36],{"name":30,"affiliation":31,"role":32},"Monthira Maneerattanaporn, MD","Mahidol University Faculty of Medicine Siriraj Hospital","STUDY_DIRECTOR",{"name":34,"affiliation":31,"role":35},"Tanawat Geeratragool, MD","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":31,"role":38},"Somchai Leelakusolvong, MD","STUDY_CHAIR",[40,44],{"name":30,"role":41,"phone":42,"phoneExt":24,"email":43},"CONTACT","662419777","monthira.man@mahidol.ac.th",{"name":34,"role":41,"phone":45,"phoneExt":24,"email":46},"66823430096","tanawat.grtg@gmail.com",{"type":35,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Watcharasak Chotiyaputta","Associate Professor","100583086","effect-of-a-low-fodmap-diet-in-ibs-and-functional-constipation-with-bloating-a-randomized-double-blind-trial-100583086",false,"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","ALL","18 Years",{"count":60,"type":61},34,"ESTIMATED","INTERVENTIONAL",[64],"NA","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.",[67,68,69],"Irritable Bowel Syndrome (IBS)","Constipation - Functional","Bloating",[67,71,72,73],"Functional Constipation","FODMAP","Microbiota","NOT_YET_RECRUITING","2025-03-06",{"date":77,"type":78},"2025-03-12","ACTUAL",{"date":80,"type":61},"2025-03-15",{"date":82,"type":61},"2026-07-31",{"name":5,"class":6}]