[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"epigastric-pain-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:epigastric-pain-syndrome":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,84],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":4},"100640497","cognitive-behavioral-therapy-for-functional-dyspepsia-epigastric-pain-syndrome-and-postprandial-distress-syndrome-subtypes-100640497",false,"NCT07577089","Cognitive Behavioral Therapy for Functional Dyspepsia (Epigastric Pain Syndrome and Postprandial Distress Syndrome Subtypes)","Multimodal Phenotyping of Functional Dyspepsia: Controlled Trial on Response to Cognitive-Behavioral Therapy in Subtypes of Epigastric Pain Syndrome and Postprandial Discomfort Syndrome","FD-CBT","Inclusion Criteria:\n\n* Age 18-65 years\n* Diagnosis of Functional Dyspepsia according to Rome IV criteria\n* Classification as Epigastric Pain Syndrome (EPS) or Postprandial Distress Syndrome (PDS)\n* Active symptoms within the last month\n* Willingness to participate in Cognitive Behavioral Therapy and provide biological samples for research\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Presence of structural gastrointestinal disease (e.g., peptic ulcer, malignancy)\n* History of major abdominal surgery affecting the stomach or small intestine\n* Severe psychiatric disorders (e.g., psychosis, bipolar disorder) interfering with participation\n* Current participation in other interventional clinical trials\n* Use of medications that may confound study outcomes (e.g., chronic corticosteroids, immunosuppressants)\n* Pregnancy or breastfeeding","ALL","18 Years","65 Years",{"count":21,"type":22},90,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to learn whether adding Cognitive Behavioral Therapy (CBT) to standard medical treatment can improve symptoms in adults with Functional Dyspepsia. The study includes adults aged 18 to 65 years diagnosed with Functional Dyspepsia, classified as Epigastric Pain Syndrome or Postprandial Distress Syndrome.\n\nThe main questions it aims to answer are:\n\nDoes Cognitive Behavioral Therapy added to standard treatment reduce gastrointestinal symptoms compared with standard treatment alone? Do patients with Postprandial Distress Syndrome and Epigastric Pain Syndrome respond differently to Cognitive Behavioral Therapy? Researchers will compare optimized standard medical treatment alone to optimized standard treatment combined with Cognitive Behavioral Therapy to see if the addition of CBT leads to greater symptom improvement and better quality of life.\n\nParticipants will:\n\nBe randomly assigned to receive either standard medical treatment alone or standard treatment plus Cognitive Behavioral Therapy Take part in clinical visits and complete questionnaires about gastrointestinal symptoms, psychological well-being, and quality of life Provide blood, saliva, and stool samples at several time points over a 12-month follow-up period",[28,29,30],"Functional Dyspepsia","Epigastric Pain Syndrome","Postprandial Distress Syndrome",[28,32,29,30,33,34,35,36,37,38,39,40],"Cognitive Behavioral Therapy","Gut-Brain Axis","Microbiota","Randomized Controlled Trial","Disorders of Gut-Brain Interaction","Gastrointestinal Symptoms","Inflammation","Biomarkers","Precision Medicine","NOT_YET_RECRUITING","2026-05-05",{"date":44,"type":45},"2026-05-11","ACTUAL",{"date":47,"type":22},"2026-04",{"date":49,"type":22},"2028-12",{"name":51,"class":52},"Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis","OTHER",{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":17,"minAge":18,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":23,"phases":64,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100637154","phase-4-effect-of-digestive-enzymes-as-add-on-therapy-on-patients-with-functional-dyspepsia-100637154","NCT07578402","Effect of Digestive Enzymes as Add on Therapy on Patients With Functional Dyspepsia.","Effect of Digestive Enzymes as Add on Therapy on Patients With Functional Dyspepsia - A Randomised, Open Label Trial","Inclusion Criteria:\n\n* Age 18 years or more\n* Patients with FD diagnosed according to ROME IV criteria\n\nExclusion Criteria:\n\n* Structural lesion in endoscopy and positive H. pylori status\n* History of malignancy, liver and biliary tract disease, diabetes mellitus, chronic kidney disease, thyroid disorders\n* Psychiatric disorders\n* Previous history gastrointestinal surgery\n* Any history of hypersensitivity, adverse effect, or ineffectiveness with digestive enzyme\n* Pregnancy and breastfeeding.",true,"70 Years",{"count":63,"type":22},120,[65],"PHASE4","The goal of this clinical trial is to assess the effect of digestive enzymes in improving dyspeptic symptoms in patients with functional dyspepsia. It will also assess about the safety of drug by recording the patient reported adverse events. The main questions it aims to answer are:\n\nDoes drug digestive enzymes has any effect on patients with functional dyspepsia? What medical problems do participants have when taking drug digestive enzymes? Researcher will compare drug digestive enzymes to a control group taking standard first line treatment only.\n\nParticipants will:\n\nTake drug digestive enzymes 325 milligrams 3 times daily, every day for 4 weeks along with standard first line treatment. A second group will be taken as control arm who will be kept on standard first line treatment only for 4 weeks. They will visit the hospital 2 weekly, and their symptoms will be assessed by a 5-point Likert Scale at baseline, week 2 and 4. Additionally, patient reported adverse events will be documented.",[68,69,29,70],"Dyspepsia","Functioanl Dyspepsia","Epigastric Fullness",[68,72,73,74,75],"Post parendial distress syndrome (PPDS)","Epigastric pain syndrome (EPS)","Functional dyspepsia (FD)","Disorder of gut brain interaction (DGBI)",{"date":44,"type":45},{"date":78,"type":22},"2026-05-15",{"date":80,"type":22},"2027-02-28",{"name":82,"class":52},"Rakibul Mostafa",1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":83},"100605652","postprandial-distress-itopride-cohort-trial-100605652","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.",{"count":93,"type":22},200,"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.",[30,28,29],"2025-09-02",{"date":99,"type":45},"2025-09-10",{"date":101,"type":22},"2025-10",{"date":103,"type":22},"2026-07-31",{"name":105,"class":52},"Universitaire Ziekenhuizen KU Leuven"]