[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-prandial-distress-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-prandial-distress-syndrome":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100627519","phase-4-comparing-acotiamide-and-itopride-for-the-management-of-indigestion-100627519",false,"NCT07449689","Comparing Acotiamide and Itopride for the Management of Indigestion","A Double-Blind Superiority Randomized Controlled Trial Comparing Acotiamide vs Itopride for Functional Dyspepsia Management","Inclusion Criteria\n\n* Patients experiencing bothersome post-prandial fullness or bothersome early satiation at least three days a week.\n* Symptom onset must have occurred six months prior to diagnosis, and symptoms must have been present for at least the past three months.\n* No evidence of organic, systemic, or metabolic disease based on clinical investigations and endoscopy.\n* Patients with co-existing symptoms of Epigastric Pain Syndrome (EPS) are included only if the symptoms causing the most distress are meal-related.\n* Individuals who have already tested negative for H. pylori (separate tests will not be conducted for the study).\n\nExclusion Criteria\n\n* Patients with an identifiable organic disease that can explain their symptoms, such as peptic ulcer, GERD, or chronic pancreatitis.\n* Patients with a history of gastrointestinal surgery.\n* History of malignancy in the past five years.\n* Patients having major psychiatric or depressive disorders.\n* Patients with a history of drug or alcohol abuse.\n* Patients with advanced chronic kidney disease.\n* Patients with uncontrolled diabetes (HbA1c \\>8).\n* Patients with uncontrolled hypertension.\n* Patients diagnosed with Irritable Bowel Syndrome.\n* Pregnant or lactating women.\n* Patients who have used antibiotics, opioids, or any other medication that -affects gastrointestinal function in the past 4 weeks.\n* H. pylori positive patients.\n* Patients who cannot fill out scales or record their symptoms.","ALL","18 Years","70 Years",{"count":20,"type":21},368,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This study is a randomized, double-blinded trial that will compare the effectiveness of two medications, acotiamide and itopride, in treating Functional Dyspepsia. Functional Dyspepsia causes uncomfortable symptoms arising from the gastro-duodenal region, such as fullness after meals, early satiation, stomach pain, and burning.\n\nThe primary aim of this trial is to determine whether acotiamide is superior to itopride-specifically by a margin of 15%-at improving these meal-related digestive symptoms.\n\nParticipants will be involved in the study for a total of 5 weeks. The study begins with a 7-day baseline period where participants will track their symptoms daily.\n\nFollowing the baseline period, participants will be randomly assigned to receive either 100mg of acotiamide three times a day or 50mg of itopride three times a day.\n\nThe treatment phase will last for 4 weeks, during which participants will take the medication before meals on an empty stomach.\n\nParticipants will continue to track their symptoms daily and will complete questionnaires about their overall treatment effect and quality of life at follow-up visits.",[27,28],"Functioanl Dyspepsia","Post Prandial Distress Syndrome",[30,31,32,33,34],"Functional Dyspepsia","Acotiamide","Itopride","Post-Prandial Distress Syndrome","Gastroprokinetic","NOT_YET_RECRUITING","2026-03-05",{"date":38,"type":39},"2026-03-06","ACTUAL",{"date":41,"type":21},"2026-04",{"date":43,"type":21},"2027-05",{"name":45,"class":46},"Aga Khan University","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":74,"locationsCount":76},"100484368","exposure-based-cbt-for-avoidantrestrictive-food-intake-in-functional-dyspepsia-100484368","NCT05587127","Exposure-Based CBT for Avoidant\u002FRestrictive Food Intake in Functional Dyspepsia","A Randomized Controlled Trial of Exposure-Based Cognitive Behavioral Treatment for Avoidant\u002FRestrictive Food Intake in Functional Dyspepsia","Inclusion Criteria\n\n* Age at least 18 years at screening visit\n* Rome IV Functional Dyspepsia post-prandial distress type (with or without epigastric pain syndrome)\n* Negative upper endoscopy or upper radiographic GI series to rule out structural\u002Forganic cause for FD\n* Avoidant\u002FRestrictive Food Intake Disorder (ARFID) diagnosis (by the Structured Clinical Interview for DSM-5; SCID-5 at Screening visit)\n* ≥5% weight loss from weight after functional dyspepsia symptom onset (at Screening visit)\n* Stable for outpatient care (based on the American Psychiatric Association Practice Guideline for the Treatment of Patients with Eating Disorders)\n* No previous history of CBT for functional dyspepsia or ARFID\n* Computer\u002Finternet webcam access\n* Fluency in English\n* Stable dose for 30 days if on any medication\n\nExclusion Criteria\n\n* Inability to provide informed consent\n* Presence of other conditions that could explain the patient's symptoms by chart:\n\nPyloric or intestinal obstruction (by EGD, UGI, or Abdominal CT) Active H.pylori infection (by CLO test or stool antigen test) Active inflammatory bowel disease Eosinophilic gastroenteritis or eosinophilic esophagitis Acute renal failure Chronic renal failure (serum creatinine \\>3 mg\u002FdL) and\u002For on hemodialysis or peritoneal dialysis Acute liver failure Any acute gastrointestinal process Any plausible structural or metabolic causes Heartburn as predominant symptom History of peptic ulcer\n\n* Symptom resolution with antisecretory therapy (PPI use for other reasons that did not resolve FD symptoms will be allowed)\n* History of gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection)\n* History of any serious medical condition (e.g., cancer)\n* Use of narcotic analgesics greater than three days per week\n* Current pregnancy or breastfeeding within the last 8 weeks\n* Uncontrolled diabetes (indicated by HbA1c ≥7%) by chart\n* Intellectual disability by history\n* Current substance\u002Falcohol use disorder within the past month\n* Current\u002Fhistory of psychosis (by Mini-International Neuropsychiatric Interview (MINI-Screen)\n* Current mania (by Mini-International Neuropsychiatric Interview (MINI-Screen) (defined as any manic episodes within the past 12 months)\n* Active suicidal ideation (by MINI-Screen)\n* Psychiatric disorder that would warrant independent attention (by Mini-International - Neuropsychiatric Interview (MINI-Screen))\n* Current enteral or parenteral feeding\n* Plans to initiate another psychotherapy or pregnancy in the concurrent study period",{"count":55,"type":21},50,[57],"NA","Randomized controlled trial of an exposure-based behavioral treatment (CBT) in adults with functional dyspepsia who meet criteria for avoidant\u002Frestrictive food intake disorder (ARFID) with weight loss.",[60,61,62,63,64,30,65,66],"Avoidant\u002FRestrictive Food Intake Disorder","Dyspepsia","Feeding and Eating Disorders","Cognitive Behavioral Therapy","Appetite Regulation","Post-prandial Distress Syndrome","Behavioral Medicine","RECRUITING","2025-09-22",{"date":70,"type":39},"2025-09-25",{"date":72,"type":39},"2022-11-30",{"date":43,"type":21},{"name":75,"class":46},"Massachusetts General Hospital",1]