[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605652":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":11,"locations":22,"responsibleParty":41,"collaborators":10,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":45,"sex":51,"minAge":52,"maxAge":10,"enrollmentInfo":53,"targetDuration":10,"studyType":56,"phases":10,"briefSummary":57,"conditions":58,"keywords":10,"overallStatus":62,"whyStopped":10,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":10},"Functional dyspepsia patients",null,[12,18],{"name":13,"role":14,"phone":15,"phoneExt":16,"email":17},"Jan Tack, MD","CONTACT","16 34 42 25","+32","jan.tack@kuleuven.be",{"name":19,"role":14,"phone":20,"phoneExt":16,"email":21},"Janne Scheepers, MPharm","16 32 89 61","janne.scheepers@kuleuven.be",[23],{"facility":24,"status":10,"city":25,"state":10,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"UZ Leuven","Leuven","3000","Belgium","BE",{"type":30,"coordinates":31},"Point",[32,33],4.70093,50.87959,{"lat":33,"lon":32},[36,38,39],{"name":13,"role":14,"phone":15,"phoneExt":37,"email":17},"32",{"name":19,"role":14,"phone":20,"phoneExt":16,"email":21},{"name":13,"role":40,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":42,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100605652","postprandial-distress-itopride-cohort-trial-100605652",false,"NCT07165301","Postprandial Distress Itopride Cohort Trial","Prospective Cohort Study of Functional Dyspepsia\u002FPostprandial Distress Syndrome Patients Treated With Itopride","PASSPORT","Inclusion Criteria:\n\n* Patient diagnosed with functional dyspepsia as per physician clinical criteria\n* Patient must sign an informed consent document before the initiation of any study-related procedures indicating that he or she understands the purpose and procedures required for the study and is willing to participate in the study.\n* Patient must speak Dutch or French\n\nExclusion Criteria:\n\n* Patient with other clinical diagnosis than functional dyspepsia that can explain their gastrointestinal symptoms.\n* Patient has any of the following surgical history:\n\n  * Any abdominal surgery within the 3 months prior to screening;\n  * Subject has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, cholecystectomy, or polypectomy more than 3 months earlier are allowed).\n* Patient has an unstable cardiac, pulmonary, renal, hepatic, metabolic, or hematologic condition.\n* Patient has a history of active malignancy within 3 years before screening (except squamous and basal cell carcinomas and cervical carcinoma in situ).\n* Patient has received an investigational drug or used an investigational medical device within 30 days prior to randomization, or is currently enrolled in an investigational study.\n* In case of psychotropic drug use: patient NOT on stable doses of antidepressants (i.e., for the 3 months prior to pre-screening) will not be allowed to participate in the study. Habitual use of benzodiazepines is permitted.\n* Patient is pregnant or breastfeeding.\n* Patient has any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.","ALL","18 Years",{"count":54,"type":55},200,"ESTIMATED","OBSERVATIONAL","Functional Dyspepsia (FD) is a common gastrointestinal disorder affecting about 7.2% of the population, characterized by gastroduodenal symptoms without an identifiable organic cause. It is divided into two subtypes based on the Rome IV criteria: (i) Postprandial Distress Syndrome (PDS): Meal-related symptoms like postprandial fullness and early satiation.; (ii) Epigastric Pain Syndrome (EPS): Meal-unrelated symptoms like epigastric pain or burning.\n\nTreatment options are limited, but prokinetics are commonly used, targeting suspected motility issues. A meta-analysis showed prokinetics reduce symptoms. Itopride, a D2 antagonist and acetylcholinesterase inhibitor, has shown potential efficacy, especially in Asian populations.\n\nAs Itopride became available in Belgium since 2023, there is a lack of real-life outcome data in Western patients with functional dyspepsia\u002Fpostprandial distress syndrome who receive treatment in standard clinical practice. Hence, the aim of this pragmatic observational study is to follow up a cohort of functional dyspepsia\u002Fpostprandial distress syndrome patients in whom itopride treatment is started as part of routine clinical practice.",[59,60,61],"Postprandial Distress Syndrome","Functional Dyspepsia","Epigastric Pain Syndrome","NOT_YET_RECRUITING","2025-09-02",{"date":65,"type":66},"2025-09-10","ACTUAL",{"date":68,"type":55},"2025-10",{"date":70,"type":55},"2026-07-31",{"name":5,"class":6},1]