[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503228":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":19,"locations":20,"responsibleParty":44,"collaborators":19,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":19,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":19,"overallStatus":23,"whyStopped":19,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"FD patient","EXPERIMENTAL","Low-FODMAP diet in patients with FD for 6 weeks.",[13],"Other: Low-FODMAP diet",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Low-FODMAP diet","6-week Low-FODMAP diet in patients with functional dyspepsia",[9],null,[21],{"facility":22,"status":23,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"KU Leuven","RECRUITING","Leuven","Vlaams-Brabant","3000","Belgium","BE",{"type":30,"coordinates":31},"Point",[32,33],4.70093,50.87959,{"lat":33,"lon":32},[36,41],{"name":37,"role":38,"phone":39,"phoneExt":19,"email":40},"Jan Tack, PhD, MD","CONTACT","0032163332211","jan.tack@kuleuven.be",{"name":42,"role":43,"phone":19,"phoneExt":19,"email":19},"Bert Broeders, MD","SUB_INVESTIGATOR",{"type":45,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100503228","low-fodmap-diet-in-fd-pds-100503228",false,"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.","ALL","18 Years","70 Years",{"count":58,"type":59},30,"ESTIMATED","INTERVENTIONAL",[62],"NA","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.",[65],"Functional Gastrointestinal Disorders","2024-06-28",{"date":68,"type":69},"2024-07-01","ACTUAL",{"date":71,"type":69},"2022-10-03",{"date":73,"type":59},"2025-02-15",{"name":5,"class":6},1]