[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"functional-dyspepsia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:functional-dyspepsia":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,35,0,25,[9,43,75,105,140,174,199,232,260,289,318,340,369,389,418,440,454,484,508,529,556,578,598,618,643],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100581731","prokinetics-and-body-surface-gastric-mapping-in-dyspeptic-patients-baseline-and-treatment-effects-100581731",false,"NCT06854120","Prokinetics and Body Surface Gastric Mapping in Dyspeptic Patients: Baseline and Treatment Effects","Body Surface Gastric Mapping in Patients With Dyspeptic Symptoms: Recordings at Baseline and on Medical Therapy","Inclusion Criteria:\n\n* Patients 18 years of age and older\n* Diagnosis of gastroparesis and\u002For functional dyspepsia\n* Being prescribed a prokinetic agent or symptom modulator for their clinical care\n* Able to undergo BSGM recording both before and during treatment\n* Able to give informed consent for undergoing a baseline BSGM recording and an additional recording while on treatment\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Prior surgery on esophagus, stomach (appendectomy and cholecystectomy are allowed)\n* History of skin allergies or a history of extreme sensitivity to cosmetics or lotions\n* Pregnant women\n* No vulnerable groups such as prisoners, individuals with known cognitive impairment, or institutionalized individuals be involved","ALL","18 Years",{"count":20,"type":21},125,"ESTIMATED","OBSERVATIONAL","Functional dyspepsia and gastroparesis are common stomach disorders with symptoms like early satiety, nausea, and abdominal pain, and are often evaluated with gastric emptying tests, although the correlation with symptoms is weak. Prokinetic agents (e.g., metoclopramide, erythromycin) and symptom modulators (e.g., nortriptyline, mirtazapine) are commonly used, but selecting the right medication can be difficult, as it's often based on symptoms rather than the underlying gastric issues. Body Surface Gastric Mapping (BSGM) using the Gastric Alimetry device is a novel, non-invasive tool to assess gastric myoelectrical activity and symptoms. This study aims to perform two BSGM recordings-one before and one after medical therapy-to understand how medications affect gastric function and identify baseline BSGM factors that could predict responses to treatment, potentially guiding tailored therapies based on individual gastric dysfunction.",[25,26],"Gastroparesis","Functional Dyspepsia",[25,26,28,29],"Gastric Motility","Body Surface Gastric Mapping","RECRUITING","2026-06-08",{"date":33,"type":34},"2026-06-11","ACTUAL",{"date":36,"type":34},"2025-02-26",{"date":38,"type":21},"2028-08-26",{"name":40,"class":41},"University of Auckland, New Zealand","OTHER",3,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100592960","mechanism-of-fodmap-restriction-on-fgid-patients-100592960","NCT07000227","Mechanism of FODMAP Restriction on FGID Patients","Mechanism of FODMAP Restriction on Gut Microbiota and Gut Barrier Function in Functional Gastrointestinal Disorder Patients : A Randomised Controlled Trial","BRIDGE","Inclusion Criteria:\n\n* Aged 18 and above\n* Able to provide informed consent\n* Those with pre-existing irritable bowel syndrome (IBS) or functional dyspepsia (FD) or both screened by gastroenterologists\n* Meet the ROME III- Asian criteria for FGID\n* Able to communicate in Malay or English language\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* History declared by the participant of pre-existing gastrointestinal disorder, including but not limited to Inflammatory Bowel Disease, Coeliac Disease, Pancreatitis, Gallstone disease (biliary colic, cholecystitis), Diverticulitis\n* Cancer of any kind\n* Patients with reported history of previous resection of any part of the GI tract other than appendix or gall bladder, intestinal stoma\n* Habitual use of opiate analgesics likely to alter bowel function e.g. morphine\n* Use of antibiotics in the preceding two weeks and\u002For in the past one month\n* Consumption of probiotics, prebiotics or fibre supplements in the past one month\n* Enteral feeding or texture modified diet patients\n* Those with cognitive impairment or severe mental disorder (Alzheimer's, schizophrenia, bipolar disorder. etc)\n* Shift workers (e.g. Nurse, doctors)",{"count":52,"type":21},60,"INTERVENTIONAL",[55],"NA","Brief Summary :\n\nThe goal of this clinical trial is to investigate the effects of differing FODMAP diets on gut microbiota, gut barrier function, symptom severity, quality of life, and psychological status in FGID patients. The main question it aims to answer is :\n\nHow does diets with differing FODMAP content affect the gut microbiota, gut barrier function, symptom severity, psychological status and quality of life in patients with FGID ? Researchers will compare low FODMAP diet, Gentle FODMAP diet and Traditional Dietary Advice (NICE guidelines) to see which diet is more suitable and effective for Malaysian FGID patients.\n\nParticipants will :\n\nBe given either low FODMAP diet, Gentle FODMAP diet or Traditional Dietary Advice intervention and will be required to follow the intervention for two weeks.\n\nBe required to provide stool and blood samples during baseline and intervention Record 4 day food diary and complete assessing questionnaires during baseline and intervention",[58,59,26],"Functional Gastrointestinal Disorders (FGIDs)","Irritable Bowel Syndrome (IBS)",[61,62,26,63,64],"Functional Gastrointestinal Disorder","Irritable Bowel Syndrome","FODMAP Restriction","Gentle FODMAP","2026-05-08",{"date":67,"type":34},"2026-05-11",{"date":69,"type":34},"2025-07-20",{"date":71,"type":21},"2026-09-30",{"name":73,"class":41},"Universiti Kebangsaan Malaysia Medical Centre",1,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":53,"phases":83,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100639939","ncws-or-ibsfd-in-relatives-of-cd-patients-100639939","NCT07584473","NCWS or IBS\u002FFD in Relatives of CD Patients","Inclusion criteria\n\n* CD patient's relatives\n* \\>18 years old\n* reporting IBS\u002FFD-like and extraintestinal (EI) symptoms\n\nExclusion criteria\n\n* self-exclusion of wheat from the diet and refuse to reintroduce it for diagnostic purposes;\n* drug and\u002For alcohol (\\>30 g\u002Fday for men and \\>20 g\u002Fday for women) abuse;\n* treatment with steroids and\u002For non-steroidal anti-inflammatory drugs in the 2 weeks before duodenal biopsy;\n* pregnancy or breastfeeding;\n* diagnosis of chronic inflammatory bowel disease or other organic pathologies affecting the digestive system \\[e.g., IgE-mediated Wheat Allergy (WA), microscopic colitis, diverticulitis, segmental colitis associated with diverticulosis, etc.\\], neurological diseases, major psychiatric disorders, infectious diseases, immunological deficiencies, and impairments limiting physical activity.",{"count":82,"type":21},600,[55],"Over 50% of non-celiac wheat sensitivity (NCWS) patients are HLA DQ2\u002FDQ8 positive and often have a Celiac Disease (CD) family history. Studies have identified a subgroup of NCWS patients whose clinical and immunological features are closer to CD than to irritable bowel syndrome\u002Ffunctional dyspepsia (IBS\u002FFD) ('inflammatory subgroup'). The investigators hypothesized that among CD patient's relatives, there might be a high number of NCWS subjects, who hypothetically belong to the 'inflammatory subgroup'. Therefore, the aim of this multi-step project is to identify the prevalence of both self-reported NCWS and IBS\u002FFD not related to wheat ingestion among CD patient's relatives (parents, grandparents, siblings and sons).",[86,87,26,88],"Non Celiac Wheat Sensitivity","IBS (Irritable Bowel Syndrome)","Celiac Disease",[90,91,92,93,94],"non celiac wheat sensitivity","irritable bowel syndrome","functional dyspepsia","celiac disease","Relatives","2026-05-07",{"date":97,"type":34},"2026-05-13",{"date":99,"type":34},"2026-04-01",{"date":101,"type":21},"2028-04-30",{"name":103,"class":41},"University of Palermo",2,{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":53,"phases":116,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":4},"100640497","cognitive-behavioral-therapy-for-functional-dyspepsia-epigastric-pain-syndrome-and-postprandial-distress-syndrome-subtypes-100640497","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","65 Years",{"count":115,"type":21},90,[55],"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",[26,119,120],"Epigastric Pain Syndrome","Postprandial Distress Syndrome",[26,122,119,120,123,124,125,126,127,128,129,130],"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":67,"type":34},{"date":135,"type":21},"2026-04",{"date":137,"type":21},"2028-12",{"name":139,"class":41},"Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis",{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":53,"phases":149,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":74},"100593576","phase-2-effect-of-amitriptyline-and-trifluoperazine-on-patients-with-functional-dyspepsia-100593576","NCT07008235","Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia","Inclusion Criteria:\n\n* Age 18 years or more\n* Patients with symptoms of dyspepsia for duration consisted with ROME IV criteria\n* Patients who are willing to sign informed written consent\n\nExclusion Criteria:\n\n* Structural lesion in Upper GI endoscopy and\u002For positive CLO test\n* Patients scoring 1 or 2 on the 5-point Likert scale for all four dyspepsia symptoms\n* History of malignancy, significant liver and biliary tract disease, hypertension, diabetes mellitus, chronic kidney disease, thyroid disorder, major psychiatric disorders\n* Previous history of gastrointestinal surgery\n* Patients those have to take any drug for other medical condition that may cause dyspepsia, can interfere or whose co-prescription is contraindicated with amitriptyline or trifluoperazine\n* Any patient with ongoing treatment with antidepressants or antipsychotics\n* Any history of hypersensitivity, adverse effect, or ineffectiveness with amitriptyline or trifluoperazine\n* Patients for whom Amitriptyline and Trifluoperazine are contraindicated\n* Elderly patients\\> 60 years\n* Pregnancy and breastfeeding","60 Years",{"count":148,"type":21},120,[150,151],"PHASE2","PHASE3","The goal of this clinical trial is to assess and compare the effect of amitriptyline and trifluoperazine in improving dyspeptic symptoms in patients with functional dyspepsia. It will also assess about the safety of drugs amitriptyline and trifluoperazine by recording the patient reported adverse events. The main questions it aims to answer are:\n\nDoes drug amitriptyline and trifluoperazine has any effect on patients with functional dyspepsia? What medical problems do participants have when taking drug amitriptyline and trifluoperazine? Researcher will compare drug amitriptyline and trifluoperazine to a control group taking standard first line treatment only.\n\nParticipants will:\n\nTake drug amitriptyline 10 milligrams at night or trifluoperazine 1 milligrams twice daily every day for 8 weeks along with standard first line treatment. A third group will be taken as control arm who will be kept on standard first line treatment only for 8 weeks. After that all three groups will be kept only on standard first line treatment for an additional 4 weeks. They will visit the hospital 4 weekly, and their symptoms will be assessed by a 5-point Likert Scale at baseline, week 4, 8, and 12. Additionally, patient reported adverse events will be documented.",[26],[26,155,156,157,158,159,160,161,162,163,164,165],"Amitriptyline","Trifluoperazine","Neuromodulator","DGBI","Disorders of Gut Brain Interaction","ROME IV","5-point Likert Scale","Tricyclic antidepressant","Phenothiazine","Antipsychotic","Dyspepsia","2026-05-04",{"date":95,"type":34},{"date":169,"type":34},"2025-07-01",{"date":171,"type":21},"2026-06",{"name":173,"class":41},"Md. Moktadirul Hoque Shuvo",{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":181,"sex":17,"minAge":182,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":53,"phases":185,"briefSummary":186,"conditions":187,"keywords":188,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":74},"100399536","clinical-trial-for-the-evaluation-of-the-efficacy-and-safety-of-edl-on-dyspepsia-100399536","NCT04482478","Clinical Trial for the Evaluation of the Efficacy and Safety of EDL on Dyspepsia","A 12 Week, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of EDL on Dyspepsia","Inclusion Criteria:\n\n1. Those over the age of 19\n2. Those diagnosed with functional dyspepsia (Rome IV\\*)\n\n   \\* One or more of the following symptoms are diagnosed when there is no organic cause in the test including the upper gastrointestinal endoscopy(if symptoms begin 6 months prior to Visit 1, and the symptoms are present in the past 3 months).\n   * Othersome postprandial fullness\n   * Unpleasant early satiation\n   * Unpleasant epigastric pain\n   * Unpleasant epigastric burning\n3. A person who has 4 or more of the 10 symptoms in the GIS (Gastrointestinal Symptom) questionnaire and has a total score of 12 or more (5-point Likert scale)\n4. When there is no organic disease in the gastroscopy performed at Visit 1 (however, it can be replaced by the test results within 3 months from Visit 1)\n5. A person who consented to participate in this clinical trial and signed a Informed consent form before the trail began.\n\nExclusion Criteria:\n\n1. Persons who are currently being treated with severe cardiovascular system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, nervous system, musculoskeletal system, mental, infectious diseases, and malignant tumors (however, considering the condition of the subjects, subjects can participate in the test according to investigator's judgment.)\n2. Persons with a history of peptic ulcer and reflux esophagitis within 6 months of Visit 1\n3. Those who have gastrointestinal surgery (except appendectomy and hemorrhoidectomy)\n4. Persons with a history of malignancy of the digestive system\n5. Those who have taken H2 receptor blockers, anticholinergic agents (muscarinic receptor antagonists), gastrin receptor antagonists, prostaglandin preparations, proton pump inhibitors, gastric mucosal protective agents, other drugs intended to treat gastritis, gastric health-related health functional food within 2 weeks of Visit 1\n6. Those who need to constantly take medications that can cause gastritis, such as adrenal cortical hormones, nonsteroidal anti-inflammatory drugs, and aspirin during the human application test {However, low-dose aspirin for cardiovascular disease prevention (100 mg\u002Fday or less) permit}\n7. In the Drinking Habit Questionnaire, those who had an average alcohol intake of 14 units or more for men and or more 7 units for women per week for the past month.\n8. Uncontrolled hypertension persons (systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 100 mmHg or higher, measurement criteria after 10 minutes of stability in human subjects)\n9. Persons with uncontrolled diabetes (fasting blood sugar is over 180 mg\u002FdL)\n10. Those whose Creatinine is more than twice the normal upper limit of the study institution\n11. Those whose AST(GOT) or ALT(GPT) is more than 3 times the normal upper limit of the study institution\n12. Persons who are sensitive or allergic to investigational product for this clinical trial\n13. Pregnant, lactating or planning to become pregnant within 3 months\n14. Those who participated in other clinical trials within 3 months of Visit 1 or plan to participate in other clinical trials after the start of this clinical trials.\n15. A person who determines that the Investigator is inappropriate for clinical trials\n16. Employee of Department of Digestive Internal Medicine, Seoul National University Bundang Hospital",true,"19 Years",{"count":184,"type":21},100,[55],"This clinical trial was designed to evaluate the functional and safety effects on dyspeptic symptoms compared to the placebo when ingested with EDL (Extract of Dolichos lablab Linne) in adults who complain of dyspeptic symptoms.",[26],[26,189],"GSRS","2026-04-23",{"date":192,"type":34},"2026-04-28",{"date":194,"type":34},"2020-07-01",{"date":196,"type":21},"2026-12-30",{"name":198,"class":41},"Seoul National University Bundang Hospital",{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":208,"conditions":209,"keywords":210,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":74},"100634389","psychoemotional-status-and-functional-gastrointestinal-disorders-100634389","NCT07539051","Psychoemotional Status and Functional Gastrointestinal Disorders","Assessment of the Influence of Psychoemotional Status on the Clinical Course of Functional Disorders of the Stomach and Intestine","Inclusion Criteria:\n\n* Age 18 years and older\n* Diagnosis of irritable bowel syndrome and\u002For functional dyspepsia according to Rome IV criteria\n* Written informed consent for participation in the study\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Clinical presentation not meeting Rome IV criteria\n* Inflammatory bowel disease\n* Pregnancy or lactation\n* Malignant neoplasms of any localization\n* History of gastrointestinal surgery",{"count":207,"type":21},150,"This prospective cohort study will evaluate the influence of psychoemotional status on the clinical course and quality of life of adult patients with functional dyspepsia and\u002For irritable bowel syndrome diagnosed according to Rome IV criteria. The study aims to assess the contribution of affective and somatoform disorders to quality of life and symptom burden in these patients. In participants with functional dyspepsia, the association of Helicobacter pylori status with psychoemotional status and quality of life will also be evaluated. Patients will complete validated questionnaires assessing quality of life, depression, anxiety, and somatization at baseline and again during follow-up after treatment. Clinical symptoms, pain severity, stool characteristics, and H. pylori status will also be assessed as applicable.",[26,62],[211,212,213,214,215,216,217,218,219,220,221,222],"Psychoemotional Status","Quality of Life","Anxiety","Depression","Somatization","PHQ-9","GAD-7","PHQ-15","SF-36","Helicobacter pylori","Rome IV","Gut-Brain Interaction","2026-04-13",{"date":225,"type":34},"2026-04-20",{"date":227,"type":21},"2026-05-01",{"date":229,"type":21},"2028-05-01",{"name":231,"class":41},"Center of New Medical Technologies",{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":239,"enrollmentInfo":240,"targetDuration":4,"studyType":53,"phases":242,"briefSummary":243,"conditions":244,"keywords":246,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":259},"100631123","efficacy-evaluation-of-electroacupuncture-in-the-treatment-of-functional-dyspepsia-100631123","NCT07496580","Efficacy Evaluation of Electroacupuncture in the Treatment of Functional Dyspepsia","Efficacy Evaluation of Electroacupuncture in the Treatment of Functional Dyspepsia: A Multicenter Clinical Trial Study","Inclusion Criteria:\n\n* Participants who meet the Rome IV diagnostic criteria for functional dyspepsia (FD).\n* Age 18 to 80 years, male or female.\n* Chinese patients with a normal upper gastrointestinal endoscopy within the past 1 year, or judged by a gastroenterologist with more than 3 years of clinical experience to have no structural disease that explains the symptoms.\n* Willing and able to provide written informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Functional dyspepsia symptoms caused by severe or malignant diseases (e.g., liver cirrhosis, heart failure, or gastrointestinal tumors).\n* Helicobacter pylori infection, defined as a positive urea breath test or positive Hp test on endoscopy.\n* History of gastrointestinal surgery (except minimally invasive procedures such as laparoscopy).\n* Presence of a permanent or temporary cardiac pacemaker or use of external\u002Ftemporary pacing support.\n* Use of medications that may affect dyspepsia symptoms within 2 weeks prior to enrollment, including antisecretory drugs, antacids, prokinetic agents, digestive enzymes, nonsteroidal anti-inflammatory drugs, antidepressants, or traditional Chinese medicine for FD.\n* Conditions that may make participation difficult, such as severe mental or physical illness, dementia, or illiteracy.\n* Severe coagulation disorders.\n* Acupuncture treatment for gastrointestinal diseases within the past 1 month.\n* Participation in another clinical trial within the past 2 months.\n* Drug abuse or alcohol abuse.\n* Pregnant or breastfeeding women.","80 Years",{"count":241,"type":21},105,[55],"Functional dyspepsia (FD) is a common disorder that causes stomach discomfort, such as fullness or pain after eating, without any visible structural disease. Acupuncture is often used to manage these symptoms. This study aims to evaluate the safety and effectiveness of electroacupuncture-a form of acupuncture that uses gentle electrical stimulation-for treating functional dyspepsia. Specifically, the trial will compare the benefits of applying electroacupuncture to points on the abdomen (local points) versus points on the arms and legs (distal points), alongside a control group receiving a sham (inactive) treatment. The goal is to determine the most effective acupuncture strategy for improving patients' digestive symptoms and overall quality of life.",[26,245],"Electroacupuncture",[92,247,248,249],"electroacupuncture","Local Acupoints","Distal Acupoints","2026-03-22",{"date":252,"type":34},"2026-03-27",{"date":254,"type":21},"2026-03-01",{"date":256,"type":21},"2027-12-31",{"name":258,"class":41},"The Third Affiliated hospital of Zhejiang Chinese Medical University",4,{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":53,"phases":269,"briefSummary":270,"conditions":271,"keywords":274,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":74},"100626984","auricular-stimulation-for-functional-dyspepsia-with-insomnia-efficacy-and-mechanisms-100626984","NCT07442734","Auricular Stimulation for Functional Dyspepsia With Insomnia: Efficacy and Mechanisms","Study on the Efficacy and Mechanism of Auricular Stimulation for Functional Dyspepsia With Insomnia Based on Brain Function: A Single-center, Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Meet the diagnostic criteria for functional dyspepsia and sleep disorders (25,26)\n* Pittsburgh Sleep Quality Index score ≥7\n* Right-handed, aged 18 years or above\n* Have not taken the following medications for at least 2 weeks prior to enrollment: antibiotics (oral, intramuscular, or intravenous), microbiota-related products (probiotics, prebiotics, and synbiotics, etc.), or any drugs affecting gastrointestinal flora, any drugs or supplements that improve sleep quality or suppress neural activity in the brain, medications related to functional dyspepsia treatment, or other related therapies\n* Agree to voluntarily participate in this study and sign the informed consent form\n\nExclusion Criteria:\n\n1. Secondary insomnia caused by drugs or other diseases\n2. Comorbidity with other psychiatric disorders, or severe heart, liver, kidney, or other systemic diseases\n3. Previously received this treatment method or participated in other clinical trials within the past 6 months\n4. Presence of contraindications to auricular therapy, such as allergy to skin preparation or damage at the auricular application site\n5. Pregnant or breastfeeding women\n6. History of cranial organic lesions, cranial surgery, or severe trauma",{"count":268,"type":21},176,[55],"Functional dyspepsia (FD) is a chronic disorder of gut-brain interaction characterized by bothersome upper abdominal symptoms arising from the gastroduodenal region. Diagnosis is made after clinical evaluation has excluded structural disease that could explain symptoms (e.g., upper gastrointestinal endoscopy). According to Rome IV criteria, FD is categorized into postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS), with symptom overlap commonly observed. FD is prevalent worldwide and is associated with substantial impairment in health-related quality of life and a significant socioeconomic burden.\n\nSleep disturbance, anxiety, and depression are frequent in FD and are associated with symptom severity and recurrence. Current management-such as prokinetic agents, acid-suppressive therapy, and psychotropic medications when indicated-can be limited by variable efficacy, adverse effects, and concerns regarding long-term use. The pathophysiology of FD is multifactorial and incompletely understood; increasing evidence highlights dysregulation of the brain-gut axis and autonomic nervous system function (12,13). Auricular vagus nerve-related stimulation may influence brainstem neurotransmission, gastric tone\u002Fmotility, and mood (14), suggesting a potentially safe, non-pharmacological approach for FD with comorbid sleep problems. However, the mechanistic links among autonomic regulation, gut microbiota\u002Fshort-chain fatty acids, and FD remain uncertain.\n\nThis study aims to evaluate the clinical efficacy and safety of auricular acupoint stimulation in FD patients with sleep disorders and to explore underlying mechanisms using brain-function assessments together with autonomic and gastrointestinal-related measures.",[26,272,273],"Insomnia","Brain and Nervous System",[275,26,276,277,278,279],"Auricular Acupressure","insomnia","clinical efficacy","Effect mechanism study","Brain functional areas","2026-02-24",{"date":282,"type":34},"2026-03-02",{"date":284,"type":34},"2025-10-30",{"date":286,"type":21},"2026-10-01",{"name":288,"class":41},"The First Affiliated Hospital of Zhejiang Chinese Medical University",{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":181,"sex":296,"minAge":297,"maxAge":18,"enrollmentInfo":298,"targetDuration":4,"studyType":53,"phases":299,"briefSummary":300,"conditions":301,"keywords":304,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":74},"100582430","autonomic-reactivity-and-personalized-neurostimulation-100582430","NCT06863207","Autonomic Reactivity and Personalized Neurostimulation","Autonomic Reactivity to Restore a Dysregulated Brain-Gut Axis Via Targeted Therapy","Inclusion Criteria:\n\n* 11 to 18 years of age\n* English speaking\n* meeting Rome IV diagnostic criteria for cyclic vomiting syndrome or functional dyspepsia and willingness to participate and consent\u002Fassent to the study\n* All subjects will have a constellation of chronic symptoms indicative of autonomic dysfunction for minimum 3 months: postural dizziness\u002Flightheadedness, syncope, palpitations, fatigue, sleep disturbance, thermoregulatory abnormalities and cognitive impairment with upright position +\u002F- abnormal autonomic testing if performed per standard of care as per American Autonomic Society consensus criteria.\n\nExclusion Criteria:\n\n* Presence of organic disease that may explain symptoms\n* Requirement for parenteral nutrition\n* Developmental delays precluding accurate symptom report\n* Severe dermatological condition or active infection of external or middle ear\n* Implanted electrical device\n* Severe mental health disorder not controlled by therapy (schizophrenia, bipolar disease, severe depression, post-traumatic distress disorder) and\u002For psychotic features which could influence symptom report or ANS measurements and result in adverse reactions to hypnosis therapy","FEMALE","11 Years",{"count":148,"type":21},[55],"Disorders of gut-brain interaction (DGBI) affect up to 25% of U.S. children. Patients often suffer from disabling, multisystem comorbidities that suggest a common root (sleep disturbances, fatigue, anxiety, etc). Yet, DGBI are defined and treated based on GI symptom origin (cyclic vomiting, dyspepsia, irritable bowel) rather than underlying pathophysiology. Many patients manifest comorbidities suggesting an underlying autonomic nervous system (ANS) dysregulation (palpitations, dizziness, cognitive dysfunction). Unfortunately, due to common features of anxiety and visceral hyperreactivity and lack of obvious pathology, children with DGBI are frequently diagnosed with psychosomatic or 'benign, functional disorders' and treated with empiric antidepressants despite lack of scientific support and risks of serious side effects. Little is known about the underlying brain-gut mechanisms linking these comorbidities. A lack of targeted treatment options naturally follows the paucity of mechanistic data. A dysregulated ANS response circuit via brainstem nuclei is linked to visceral hypersensitivity. As the team's prior research has shown, ANS regulation can be non-invasively measured via several validated indices of cardiac vagal tone. Using the novel vagal efficiency (VE) metric, the investigators have demonstrated inefficient vagal regulation in cyclic vomiting syndrome and pain-related DGBI and that low VE predicts response to non-invasive, auricular percutaneous electrical nerve field stimulation (PENFS) therapy. PENFS targets brainstem vagal afferent pathways and, along with brain-gut interventions such as hypnotherapy, are the only therapies currently proven effective for pediatric DGBI. Individualizing neurostimulation based on sensory thresholds while assessing dynamic ANS reactivity offers a path towards personalized medicine using the most effective therapies to date. This proposal will test the feasibility of an ANS tracking software in assessing real-time, autonomic regulation and providing individualized neurostimulation in children with nausea\u002Fvomiting and ANS imbalance.",[58,302,26,303],"Cyclic Vomiting Syndrome","Dysautonomia",[305,306,307,308],"autonomic dysfunction","auricular neurostimulation","gastric motor function","gut-directed hypnotherapy","2026-02-11",{"date":311,"type":34},"2026-02-13",{"date":313,"type":34},"2025-01-24",{"date":315,"type":21},"2029-06",{"name":317,"class":41},"Medical College of Wisconsin",{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":325,"enrollmentInfo":326,"targetDuration":4,"studyType":53,"phases":328,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":74},"100503541","functional-dyspepsia-treatment-using-virtual-reality-100503541","NCT05836597","Functional Dyspepsia Treatment Using Virtual Reality","Effectiveness and Safety of Virtual Reality for the Treatment of Functional Dyspepsia","Inclusion Criteria:\n\n* Symptoms of dyspepsia thought to represent functional dyspepsia, meeting Rome IV criteria\n* Had an upper endoscopy and assessment for Helicobacter pylori; if a patient is found to have H. pylori, treatment with confirmed eradication (by stool antigen test or urea breath test) will be required before the patient is eligible for study inclusion.\n* Patients will be considered for the study if they have undergone a complete history and physical examination during a previously scheduled consultation\u002Fevaluation visit with a gastroenterologist in the Mayo Clinic Florida General GI or Motility clinic.\n\nExclusion Criteria:\n\n* Symptoms are thought to represent an organic disorder (e.g., peptic ulcer disease, hepatitis, pancreatitis, inflammatory bowel disease, type I diabetes, a known malignancy, radiation-induced injury, an active infection, vasculitis, celiac disease), or patients have known uncontrolled GERD, esophagitis, eosinophilic esophagitis, or untreated H. pylori.\n* Patients with gastroparesis or cyclic vomiting syndrome.\n* Patients with prior surgery to the esophagus, stomach or duodenum.\n* Patients taking opioids.\n* Patients with motion sickness, vertigo, or a seizure disorder\n* IBS symptoms are not predominant.","75 Years",{"count":327,"type":21},30,[55],"The purpose of this study is to evaluate the effectiveness of using virtual reality to treat gastrointestinal symptoms related to functional dyspepsia.",[26],"2026-01-21",{"date":333,"type":34},"2026-01-22",{"date":335,"type":34},"2024-04-01",{"date":337,"type":21},"2026-12",{"name":339,"class":41},"Mayo Clinic",{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":346,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":17,"minAge":348,"maxAge":349,"enrollmentInfo":350,"targetDuration":4,"studyType":53,"phases":352,"briefSummary":353,"conditions":354,"keywords":355,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":74},"100246267","phase-3-ketotifen-for-children-with-functional-dyspepsia-in-association-with-duodenal-eosinophilia-100246267","NCT02484248","Ketotifen for Children With Functional Dyspepsia in Association With Duodenal Eosinophilia","Double-blind, Placebo-controlled, Cross-over Trial of Ketotifen in Children and Adolescents With Functional Dyspepsia in Association With Duodenal Eosinophilia","Ketotifen","Inclusion Criteria:\n\n1. between the ages of 8 and 17 years, inclusive\n2. abdominal pain of at least 8 weeks duration and fulfilling symptom-based criteria for functional dyspepsia(5);\n3. previous endoscopy with biopsies demonstrating \\>20 eosinophils\u002Fhigh powered field on duodenal mucosal biopsies;\n4. previous treatment with acid-reduction therapy and montelukast with a level 3 (as defined below)or lesser response;\n5. evidence of written parental permission (consent) and subject assent;\n6. Negative pregnancy screening for females of child bearing potential.\n\nExclusion Criteria:\n\n1. previous treatment with ketotifen;\n2. treatment with oral corticosteroids or oral cromolyn sodium in the 6 months prior to enrollment;\n3. any prior history of diabetes mellitus, cancer, chronic cardiac disease, respiratory disease, or renal disease requiring routine medical care;\n4. Pregnant\u002Fplanning to become pregnant;\n5. Post-menarche females unwilling to use highly-efficacious contraception to prevent pregnancy;\n6. Epilepsy or history of seizures;\n7. Liver disease or elevation of liver enzymes;\n8. Use of oral hypoglycemic medications, antipsychotics, benzodiazepines, tricyclic antidepressants, barbiturates, or opioids;\n9. Allergy to ketotifen or other products in capsule\n10. Refusal of Urine pregnancy test in post-menarchal females.","8 Years","17 Years",{"count":351,"type":21},40,[151],"Acid reduction remains the most common treatment prescribed empirically by pediatric gastroenterologists for children with functional dyspepsia (FD). When acid reduction therapy fails to provide patients with a therapeutic effect, ketotifen and cromolyn, mast cell stabilizers, represent an attractive potential therapy given data implicating mast cells in the generation of dyspeptic symptoms. Although there have been no adult or pediatric studies on the use of mast cell stabilizers in patients with FD, benefit has been demonstrated in adults with IBS and children with eosinophilic gastroenteritis. Additionally, previous studies show mucosal eosinophilia is highly correlated with functional dyspepsia. Our usual current treatment pathway for functional dyspepsia in association with duodenal mucosal eosinophilia is as follows: acid-reducing medication\u002Fmontelukast → addition of H1 antagonist → addition of budesonide → addition of oral cromolyn. If ketotifen is effective, it offers the advantage of being able to replace both the H1 antagonist and the oral cromolyn at a substantially reduced cost (approximately 10% of the cost of cromolyn alone). This study aims to introduce ketotifen earlier in the treatment pathway to examine its efficacy on children with functional dyspepsia in association with duodenal eosinophilia.",[26],[356,357,358,359,92],"pediatric","eosinophilia","duodenal","ketotifen","2026-01-08",{"date":362,"type":34},"2026-01-09",{"date":364,"type":34},"2015-08",{"date":366,"type":21},"2027-04-01",{"name":368,"class":41},"Craig A. Friesen, MD",{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":375,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":113,"enrollmentInfo":377,"targetDuration":4,"studyType":53,"phases":378,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":386,"locationsCount":4},"100614162","probiotics-in-functional-dyspepsia-100614162","NCT07276009","Probiotics in Functional Dyspepsia","The Effect of Multi-strain Probiotic Formulation on Gastrointestinal Symptoms, Quality of Life and Mental Health in Patients With Functional Dyspepsia: a Randomized Dietary Trial","ProPepsis","Inclusion Criteria:\n\n1. Age 18-65 years\n2. Diagnosis of Functional Dyspepsia based on Rome IV criteria, with symptoms present for at least 3 months, and symptom onset at least 6 months before diagnosis, including:\n\n   * Postprandial fullness\n   * Early satiation\n   * Epigastric pain or burning\n   * (with no evidence of structural disease explaining symptoms)\n3. Moderate to severe symptom severity at baseline, as defined by a validated scale (e.g., NDI or global symptom score)\n4. Normal upper GI endoscopy within the last 12 months (or at screening), excluding structural disease (e.g., peptic ulcer, malignancy)\n5. Negative for H. pylori (either previously treated successfully or tested negative within study screening)\n6. Ability and willingness to provide informed consent and comply with study procedures\n7. Stable medication use, if any, for at least 4 weeks before screening (e.g., PPIs, antidepressants, laxatives)\n\nExclusion Criteria:\n\n1. Evidence of structural GI disease (e.g., peptic ulcer, gastric cancer, celiac disease) on recent or screening endoscopy\n2. History of gastrointestinal surgery affecting stomach or small intestine (except appendectomy or cholecystectomy)\n3. Positive test for H. pylori during screening (or untreated known infection)\n4. Current or recent use (within 4 weeks) of antibiotics, pre-, pro- or postbiotics, unless part of study protocol\n5. Use of medications affecting GI motility (e.g., prokinetics, opioids, anticholinergics) within 2-4 weeks before enrollment\n6. Overlap with other functional GI disorders (except IBS) if they are the dominant complaint, unless your protocol allows overlap\n7. Clinically significant psychiatric illness (e.g., major depression, schizophrenia) that may interfere with symptom reporting or adherence\n8. Severe systemic or metabolic disease (e.g., uncontrolled diabetes, renal or hepatic failure)\n9. Pregnancy or lactation, or intention to become pregnant during the study period\n10. Participation in another clinical trial within the past 3 months\n11. Known allergy or intolerance to study product components",{"count":52,"type":21},[55],"The goal of this clinical trial is to learn whether a multi-strain probiotic can reduce digestive symptoms and improve quality of life in adults with functional dyspepsia. The main questions it aims to answer are:\n\n* Does the probiotic reduce symptoms such as fullness after meals, bloating, stomach discomfort, and early satiation?\n* Does the probiotic improve emotional well-being, including stress, anxiety, and mood? Researchers will compare the probiotic to a placebo (a look-alike capsule with no active ingredients) to see if the probiotic truly helps adults with functional dyspepsia.\n\nParticipants will:\n\n* Take one capsule of the probiotic or placebo once daily before meals for 60 days\n* Complete questionnaires about their digestive symptoms at the start, 1 month, and 2 months\n* Complete surveys on stress, anxiety, depression, and quality of life at the start and 2 months\n* Attend scheduled study visits for checkups and assessments",[26],"2026-01-07",{"date":360,"type":34},{"date":384,"type":21},"2026-01-05",{"date":227,"type":21},{"name":387,"class":388},"Nordic Biotic Sp. z o.o.","INDUSTRY",{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":53,"phases":399,"briefSummary":400,"conditions":401,"keywords":402,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":411,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":74},"100609309","probiotic-and-ginger-supplement-for-symptoms-and-quality-of-life-in-functional-dyspepsia-subtile-100609309","NCT07212907","Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)","Effect of a Combination of Spore-forming Probiotics (Bacillus Coagulans MY01 and Bacillus Subtilis MY02) and Ginger Extract on Symptoms and Quality of Life in Patients With Functional Dyspepsia","SUBTILE","Inclusion Criteria:\n\n* Adults (male or female) aged ≥18 years.\n* Diagnosis of functional dyspepsia (FD) according to Rome IV criteria, with normal upper endoscopy including negative Helicobacter pylori test. Rome IV criteria define FD as the presence of one or more of the following symptoms: bothersome postprandial fullness, early satiety, epigastric pain, or epigastric burning, occurring at least 3 days per week during the last 3 months, with symptom onset at least 6 months prior to diagnosis.\n* PAGI-SYM total score \\>1 at baseline.\n* Ability to comply with study requirements and provide signed written informed consent before any study-related procedures.\n* Ability to complete the patient diary and questionnaires, in the investigator's opinion (sufficient reading and language comprehension).\n* For women of childbearing potential : Negative urine pregnancy test immediately before starting study product ; Agreement to use an approved method of contraception for the duration of the study, unless meeting criteria for menopause (≥12 months of spontaneous amenorrhea). Women of childbearing potential are defined as all women physiologically capable of becoming pregnant, including those whose career, lifestyle, or sexual orientation normally precludes heterosexual intercourse.\n* Affiliation with a national health insurance or social security system.\n\nExclusion Criteria:\n\n* Use within 2 weeks prior to baseline of treatments that could interfere with study evaluation, including Bacillus coagulans MY01, Bacillus subtilis MY02, ginger, peppermint, or antibiotics.\n* Known allergy or hypersensitivity to any component of the investigational product.\n* Contraindication or specific warning related to the investigational product, including use of anticoagulants.\n* Use of immunosuppressive therapy within the last 3 months.\n* Use of medications affecting gastrointestinal motility or sensitivity, including opioids, GLP-1 analogs, neuroleptics, antiemetics, or anticholinergics. (Stable antidepressant therapy allowed.)\n* Significant changes in diet or physical activity within 2 weeks prior to baseline or anticipated during the study period.\n* Active somatic or psychiatric disorder that could explain dyspeptic symptoms (e.g., active cancer, inflammatory disease). Stable use of one antidepressant is allowed for psychiatric indication.\n* Active Helicobacter pylori infection.\n* Predominant symptoms of gastroesophageal reflux disease (GERD) or irritable bowel syndrome (IBS).\n* Functional diarrhea or functional constipation as defined by Rome IV criteria.\n* History of abdominal surgery within the past year, except appendectomy, cholecystectomy, inguinal hernia repair, or splenectomy.\n* Pregnant or breastfeeding women.\n* Individuals under legal guardianship or curatorship.\n* Participation in another interventional clinical trial and receipt of an investigational product within 30 days prior to baseline.\n* Any acute or chronic medical or psychiatric condition that, in the investigator's judgment, could interfere with study assessments, including but not limited to severe hepatic or renal insufficiency, immunodeficiency, or substance abuse (alcohol or drugs).\n* Any personal condition or circumstance that, in the investigator's judgment, would make full participation in the study unlikely or impossible.",{"count":398,"type":21},198,[55],"Functional dyspepsia (FD) is a frequent functional gastrointestinal disorder characterized by bothersome postprandial fullness, early satiety, epigastric pain, or burning, in the absence of any structural or metabolic cause. It significantly impairs quality of life and has limited therapeutic options, as conventional treatments such as proton pump inhibitors often show modest efficacy and may cause side effects with long-term use.\n\nThe gut and duodenal microbiota may play a role in FD. Spore-forming probiotics such as Bacillus coagulans MY01 and Bacillus subtilis MY02 have shown beneficial effects on FD symptoms in a randomized controlled trial. Ginger (Zingiber officinale) has a long history of traditional use as a gastroprotective agent and is supported by clinical and non-clinical data for improving gastric motility and related symptoms.\n\nThis study (SUBTILE, STO-253) is a prospective, interventional, multicenter trial conducted in France. It will evaluate the effect of a dietary supplement containing Bacillus coagulans MY01, Bacillus subtilis MY02, and ginger extract (50 mg, 20% gingerols) on FD symptoms and quality of life.\n\nA total of 198 adult patients diagnosed with FD according to Rome IV criteria and with a normal upper endoscopy will be recruited in primary care and gastroenterology practices. Participants will take one capsule of the study product daily for 8 weeks.\n\nThe primary outcome is the change in the Patient Assessment of Gastrointestinal Symptom Severity (PAGI-SYM) total score between baseline and Week 8.\n\nSecondary outcomes include changes in quality of life (PAGI-QoL), treatment adherence, use of concomitant medications, evolution of lower gastrointestinal symptoms, patient and physician global impressions of change (PGI-C, CGI-I), and satisfaction (Likert scales). An exploratory objective will assess psychological impact using the Hospital Anxiety and Depression Scale (HADS).\n\nThe study includes two site visits (baseline and end of study) and one telephone follow-up at Day 28. Safety and tolerability will be monitored through active reporting of adverse events.\n\nThe trial aims to provide new evidence on the role of probiotics combined with ginger extract as a non-pharmacological strategy to improve digestive comfort and quality of life in patients with functional dyspepsia.",[26],[26,403,404,405,406,407,408,409,410,119],"Bacillus coagulans MY01","Bacillus subtilis MY02","Ginger extract","Symbiosys Stomalex","Gut microbiota","Quality of life","Gastrointestinal symptoms","Spore-forming probiotics",{"date":381,"type":34},{"date":413,"type":34},"2025-12-22",{"date":415,"type":21},"2027-01",{"name":417,"class":388},"Biocodex",{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":239,"enrollmentInfo":425,"targetDuration":4,"studyType":53,"phases":427,"briefSummary":429,"conditions":430,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":74},"100607356","phase-4-efficacy-of-bacillus-coagulans-in-alleviating-anxiety-and-depression-in-patients-with-functional-dyspepsia-100607356","NCT07187492","Efficacy of Bacillus Coagulans in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia","Efficacy of Bacillus Coagulans in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia：A Prospective, Double-Blind, Randomized, Placebo-Controlled Clinical Trial","Inclusion Criteria:\n\n* Patients diagnosed with functional dyspepsia (FD) according to the Rome IV criteria.\n* Aged 18 to 80 years, regardless of gender.\n* Hospital Anxiety and Depression Scale (HADS) score between 8 and 14.\n\nExclusion Criteria:\n\n* Use of probiotics or antibiotics within one month prior to the trial.\n* Use of psychoactive medications (including hypnotics, sedatives, anxiolytics, or antidepressants) within one month prior to the trial.\n* Use of hormones, immunosuppressants, or cytotoxic agents within one month prior to the trial.\n* Participation in any other clinical trial within one month prior to the study.\n* Positive test for Helicobacter pylori (Hp) infection.\n* Long-term use of traditional Chinese herbal medicine.\n* Pregnancy or lactation.\n* History of drug abuse.\n* Comorbidities such as irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD), functional constipation (FC), or other significant conditions that may interfere with the trial-including severe hepatic, renal, respiratory, or autoimmune disorders; bleeding diatheses; psychiatric diseases; endocrine disorders; etc.\n* History of major surgery or diagnosis of diabetes mellitus.\n* Refusal to provide written informed consent.",{"count":426,"type":21},180,[428],"PHASE4","Objective: This study aims to evaluate the effectiveness of Bacillus coagulans in improving anxiety and depression in patients diagnosed with functional dyspepsia according to the Rome IV criteria.\n\nMethods: This trial plans to enroll 180 patients (90 per group). The study will employ a double-blind design. For patients diagnosed with FD according to the Rome IV criteria, in addition to conventional treatment (treated with Mosapride Citrate Tablets (Guangdong Anno Guocai) for Postmeal Discomfort Syndrome (PDS) and Esomeprazole Enteric Coated Tablets (Shijiazhuang Longze Pharmaceutical Guocai) for Upper Abdominal Pain Syndrome (EPS)), the experimental group was treated with Bacillus coagulans, while the control group received a placebo with the same appearance and odor.\n\nThe treatment intervention will last for 4 weeks. The main indicator of this experiment is the improvement of the Hospital Anxiety and Depression Scale (HADS score) after 4 weeks of treatment. The secondary indicators are the improvement rate of the overall treatment effectiveness evaluation questionnaire (OTE questionnaire), the improvement of the global overall symptom score (GOS score), the improvement of the simplified Nipin scale (SF-NDI), and the improvement of the Pittsburgh Sleep Index (PSQI) after 4 weeks of treatment. Upon completion of the trial, the patients' conditions will be re-evaluated, and treatment plans will be adjusted accordingly.",[26,431,214,213],"Probiotics","2025-12-29",{"date":384,"type":34},{"date":435,"type":34},"2025-09-20",{"date":437,"type":21},"2027-05-31",{"name":439,"class":41},"Xijing Hospital of Digestive Diseases",{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":239,"enrollmentInfo":446,"targetDuration":4,"studyType":53,"phases":447,"briefSummary":448,"conditions":449,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":452,"leadSponsor":453,"locationsCount":74},"100607002","phase-4-efficacy-of-clostridium-butyricum-in-alleviating-anxiety-and-depression-in-patients-with-functional-dyspepsia-100607002","NCT07182890","Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia","Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia：A Prospective, Double-Blind, Randomized, Placebo-Controlled Clinical Trial",{"count":426,"type":21},[428],"Objective: This study aims to evaluate the effectiveness of Clostridium butyricum in improving anxiety and depression in patients diagnosed with functional dyspepsia according to the Rome IV criteria.\n\nMethods: This trial plans to enroll 180 patients (90 per group). The study will employ a double-blind design. For patients diagnosed with FD according to the Rome IV criteria, in addition to conventional treatment (treated with Mosapride Citrate Tablets (Guangdong Anno Guocai) for Postmeal Discomfort Syndrome (PDS) and Esomeprazole Enteric Coated Tablets (Shijiazhuang Longze Pharmaceutical Guocai) for Upper Abdominal Pain Syndrome (EPS)), the experimental group was treated with Clostridium butyricum, while the control group received a placebo with the same appearance and odor.\n\nThe treatment intervention will last for 4 weeks. The main indicator of this experiment is the improvement of the Hospital Anxiety and Depression Scale (HADS score) after 4 weeks of treatment. The secondary indicators are the improvement rate of the overall treatment effectiveness evaluation questionnaire (OTE questionnaire), the improvement of the global overall symptom score (GOS score), the improvement of the simplified Nipin scale (SF-NDI), and the improvement of the Pittsburgh Sleep Index (PSQI) after 4 weeks of treatment. Upon completion of the trial, the patients' conditions will be re-evaluated, and treatment plans will be adjusted accordingly.",[26,431,214,213],{"date":384,"type":34},{"date":435,"type":34},{"date":437,"type":21},{"name":439,"class":41},{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":460,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":17,"minAge":348,"maxAge":349,"enrollmentInfo":462,"targetDuration":4,"studyType":53,"phases":464,"briefSummary":465,"conditions":466,"keywords":469,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":74},"100617473","pain-in-pediatric-patients---internet-interventions-for-disorders-of-gut-brain-interaction-100617473","NCT07319078","Pain in Pediatric Patients - Internet Interventions for Disorders of Gut-brain Interaction","Internet-delivered Psychological Interventions for Pediatric Disorders of Gut-brain Interaction - a Randomised Controlled Study","PIPPI","Inclusion Criteria:\n\n* Age 8-17 years\n* Basic somatic work-up completed (CRP\u002FESR, TGA, complete blood count, fecal calprotectin)\n* Confirmed DGBI diagnosis: IBS, functional abdominal pain, or functional dyspepsia (according to Rome IV criteria)\n* Any constipation must be treated according to current clinical guidelines, with stable laxative dosing for at least one month prior to referral\n* In cases of celiac disease, the participant must have followed a gluten-free diet for at least six months and TGA values must have normalized\n* For participants with a neuropsychiatric diagnosis treated with medication, at least two months must have passed since the last dose adjustment\n* At least one parent and the child\u002Fadolescent must be fluent in Swedish and willing to participate in both the educational program and treatment (regardless of randomization outcome), complete homework assignments, and respond to questionnaires\n\nExclusion Criteria:\n\n* Other organic disease that better explains the gastrointestinal symptoms\n* At referral assessment, psychiatric symptoms or psychosocial problems - such as severe bullying, high school absenteeism, or difficult family circumstances - are judged to be more prominent than the gastrointestinal problems and require more extensive, multiprofessional care than what the study can offer\n* Participants who have already completed gut-directed hypnotherapy or CBT",{"count":463,"type":21},200,[55],"Many children and adolescents often experience long-lasting stomach pain. In many cases, this is due to disorders of gut-brain interaction (DGBI), such as irritable bowel syndrome (IBS), functional abdominal pain, and functional dyspepsia. These conditions are caused by disrupted communication between the brain and the gut. They are linked to significant suffering, reduced quality of life, and higher school absenteeism. Psychological treatments such as cognitive behavioral therapy (CBT) have shown good effect, but waiting times within healthcare are often long. Therefore, there is a need for more accessible and cost-effective treatment alternatives.\n\nThe goal of this clinical trial is to explore whether gut-directed hypnotherapy, already used successfully in the Netherlands, can be implemented as a new treatment option in Swedish healthcare. In addition, the study will compare gut-directed hypnotherapy with internet-based CBT (iCBT) to learn which digital treatment works best for children and adolescents with DGBI.\n\nParticipants will:\n\nBe children or adolescents between 8 and 17 years old.\n\nFirst take part in a 4-week online education program called the \"gut-school,\" which explains the stomach, the brain, and how symptoms can be managed.\n\nIf symptoms remain after the gut-school, be randomly assigned to one of two digital treatments:\n\niCBT (internet-based cognitive behavioral therapy). 10 week long.\n\nGut-directed hypnotherapy, delivered as audio recordings to be used at home. 12 week long.\n\nAnswer online survey questions before, during, and after treatment so researchers can follow their progress.\n\nThese two treatments have never been directly compared. By comparing them, researchers hope to learn not only which treatment works best overall, but also which treatment is most suitable for different participants. The long-term aim is to make gut-directed hypnotherapy, already successful in the Netherlands, available as a treatment option in Sweden.",[467,468,26],"Irritable Bowel Disease","Functional Abdominal Pain - Not Otherwise Specified (FAP-NOS)",[308,470,471,472,473,91,474],"patient education","disorder of gut-brain intercation","cognitive behavioral therapy","functional abdominal pain","randomised controlled trial","2025-12-19",{"date":477,"type":34},"2026-01-06",{"date":479,"type":34},"2025-12-01",{"date":481,"type":21},"2030-03",{"name":483,"class":41},"Karolinska Institutet",{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":4,"eligibilityCriteria":490,"healthyVolunteers":181,"sex":17,"minAge":18,"maxAge":325,"enrollmentInfo":491,"targetDuration":493,"studyType":22,"phases":4,"briefSummary":494,"conditions":495,"keywords":497,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":74},"100612186","correlation-study-of-atrophic-gastritis-and-dyspepsia-symptoms-100612186","NCT07250308","Correlation Study of Atrophic Gastritis and Dyspepsia Symptoms","A Prospective Observational Study on the Correlation Between Pathologically Confirmed Chronic Atrophic Gastritis and Functional Dyspepsia Symptoms","Inclusion Criteria:\n\n1. Age 18-75 years\n2. Recent gastroscopic examination (within 1 year) suggesting chronic atrophic gastritis\n3. Underwent standardized pathological examination (5-point gastric mucosa biopsy according to the \"Updated Sydney System\" including antrum, body, and angle)\n4. Signed informed consent\n\nExclusion Criteria:\n\n1. Gastric cancer or suspected malignant lesions\n2. Concomitant significant other gastrointestinal diseases (e.g., ulcer, Barrett's esophagus, etc.)\n3. Autoimmune gastritis\n4. Unable to complete questionnaire survey",{"count":492,"type":21},315,"1 Day","Background:\n\nDyspepsia is a common gastrointestinal complaint globally, affecting approximately 21.8% of the population. Among patients presenting with dyspeptic symptoms, over 80% are diagnosed with functional dyspepsia (FD), while approximately 16% are found to have chronic atrophic gastritis (CAG). CAG represents an important precancerous condition in the gastric cancer cascade, yet the relationship between pathologically confirmed CAG and dyspeptic symptoms remains poorly understood. The significant symptom overlap between CAG and FD creates diagnostic challenges in clinical practice.\n\nStudy Objectives:\n\nThe primary objective is to determine whether there are significant differences in the prevalence and severity of dyspeptic symptoms (including epigastric pain, burning sensation, early satiety, and postprandial fullness) between patients with pathologically confirmed CAG and those without CAG (non-CAG group) among individuals who present with endoscopic features suggestive of atrophic gastritis.\n\nSecondary objectives include: (1) analyzing the independent effects of various covariates (Helicobacter pylori infection, dietary habits, sleep quality, psychological factors) on dyspeptic symptoms; (2) developing a symptom-based predictive model for pathological CAG; and (3) conducting exploratory serum metabolomics analysis to identify potential biomarkers and metabolic pathways associated with FD symptoms.\n\nStudy Design:\n\nThis is a single-center, prospective, observational study conducted at the Third Affiliated Hospital of Zhejiang Chinese Medical University. The study will enroll approximately 258-315 adult patients (aged 18-75 years) who undergo endoscopy showing features suggestive of CAG within the past year. All participants will undergo standardized 5-point gastric mucosal biopsy according to the Updated Sydney System. Based on histopathological results, patients will be classified into pathological CAG group (presence of gastric mucosal atrophy) or non-CAG group (absence of atrophy). The study aims to recruit at least 80 pathologically confirmed non-CAG patients for comparison.\n\nStudy Procedures:\n\nAfter obtaining informed consent, all enrolled patients will complete a comprehensive assessment at baseline including: demographic information, medical history, endoscopy and pathology results, Gastrointestinal Symptom Scale (GOSS) questionnaire using a 7-point Likert scale, H. pylori infection status (serology), dietary habits assessment, Pittsburgh Sleep Quality Index (PSQI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), and perceived stress evaluation. A subset of participants will provide fasting blood samples for non-targeted metabolomics analysis using liquid chromatography-mass spectrometry (LC-MS) to identify metabolites related to amino acids, organic acids, lipids, and neurotransmitter precursors. This is a non-interventional study with all data and sample collection completed at enrollment without long-term follow-up.\n\nPrimary Outcome:\n\nThe primary outcome is the difference between pathological CAG and non-CAG groups in the prevalence and severity of dyspeptic symptoms, particularly cardinal FD symptoms (epigastric pain, burning, early satiety, postprandial fullness), assessed using the GOSS scale. A symptom score ≥4 on any cardinal symptom will define the presence of clinically significant FD symptoms.\n\nExpected Duration:\n\nThe study is expected to last 24 months, including preparation, patient recruitment with data collection, and final statistical analysis and reporting phases.\n\nSignificance:\n\nThis study will provide evidence-based insights into the relationship between pathologically confirmed CAG and dyspeptic symptoms, potentially improving symptom management strategies and patient counseling. The metabolomics component may reveal novel biomarkers and pathways underlying symptom generation, laying groundwork for future mechanistic studies and personalized therapeutic approaches. Results will inform clinical practice and serve as preliminary data for larger-scale investigations.",[26,496],"Chronic Atrophic Gastritis (CAG)",[498,499],"Serumomics","symptom","2025-11-24",{"date":502,"type":34},"2025-11-26",{"date":504,"type":34},"2025-10-01",{"date":506,"type":21},"2026-08-31",{"name":258,"class":41},{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":512,"acronym":513,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":113,"enrollmentInfo":515,"targetDuration":4,"studyType":53,"phases":517,"briefSummary":518,"conditions":519,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":74},"100543825","synergistic-gut-brain-axis-modulation-via-vagal-stimulation-and-support-therapy-in-functional-dyspepsia-100543825","NCT06360900","Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Support Therapy in Functional Dyspepsia","CONVERGE","Inclusion Criteria:\n\nAge 18-65 years old (inclusive)\n\n* Ability to give written consent and participate in behavioral intervention in English\n* Willingness to attend weekly treatment sessions over live video, daily self-administered transcutaneous auricular vagus nerve stimulation (taVNS) sessions, and engage in homework during treatment\n* Avoidance of alcohol, nicotine, and caffeine for 24 hours prior to study session\n* Diagnosis according to the Rome IV criteria for both epigastric pain syndrome and postprandial distress syndrome subtypes\n* Stable medical treatment for functional dyspepsia (FD) during 1 month before the study and during the study period\n\nExclusion Criteria:\n\n* Previous receipt of cognitive behavioral therapy (CBT) for gastrointestinal symptoms\n* Enteral or parenteral feeding\n* Previous gastrointestinal surgery, electrolyte disturbances, kidney dysfunction, renal insufficiency, or iron overload disorders\n* Estimated Glomerular Filtration Rate (eGFR) \\\u003C 60\n* Medications that affect gastrointestinal motility in addition to medications or products containing tetrahydrocannabinol (THC) will be stopped at least 7 days prior to the start of the study and for the duration of the study. However, anti-depressants (SSRI's, TCA's) may be allowed in order to reduce the risk of worsening neuropsychiatric disease, though it will be up to the study team and the Principal Investigator whether subjects on anti-depressants will be able to participate in the study\n* Intellectual disability by history\n* Diabetes, mitochondrial disease, severe autonomic dysfunction, and small fiber polyneuropathy\n* No active clinical acupuncture therapy\n* Illicit drugs or opioid usage\n* History of arrhythmias\n* Current pregnancy\u002Fbreastfeeding\n* Contraindications for magnetic resonance imaging (MRI) (implanted ferromagnetic objects, claustrophobia)\n* Weight \\> 450 lbs. (limit of the MRI table)\n* Allergy to pineapple (used in the test meal during MRI)\n* Any other condition interfering with study requirements, according to the Investigator",{"count":516,"type":21},80,[55],"The study aims at evaluating physiological and patient-reported outcomes for a dual intervention approach including a stimulation device and support therapy in patients with functional dyspepsia.",[26],"2025-11-04",{"date":522,"type":34},"2025-11-06",{"date":524,"type":34},"2025-10-29",{"date":526,"type":21},"2029-03",{"name":528,"class":41},"Spaulding Rehabilitation Hospital",{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":17,"minAge":536,"maxAge":537,"enrollmentInfo":538,"targetDuration":4,"studyType":53,"phases":540,"briefSummary":541,"conditions":542,"keywords":547,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":551,"completionDateStruct":552,"leadSponsor":554,"locationsCount":104},"100610081","feasibility-study-of-a-guided-imagery-therapy-mobile-application-for-functional-abdominal-pain-disorders-in-children-100610081","NCT07222943","Feasibility Study of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children","Open-Labelled Feasibility Study of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children","Inclusion Criteria:\n\n* Texas Children's Pediatrics patients 7 to 12 years old at enrollment\n* A Rome IV Functional Abdominal Pain Disorder as defined by a 2-week abdominal pain and stooling diary\n* Both children and their primary caregivers must be able to read and communicate in English proficiently to understand the intervention's audio therapy sessions and psychometric instruments.\n\nExclusion Criteria:\n\n* Previous abdominal surgeries\n* Co-morbid conditions associated with abdominal pain (e.g., cystic fibrosis)\n* Autism\n* Significant development delay\n* Psychosis\n* Prior experience with cognitive behavioral therapy or guided imagery therapy to treat chronic abdominal pain\n* Alarm symptoms that warrant further medical evaluation (e.g., blood in stool)","7 Years","12 Years",{"count":539,"type":21},36,[55],"Chronic abdominal pain is common among children, and the majority of cases are attributed to functional abdominal pain disorders. One approach to treating these disorders is by using psychological therapies. This clinical trial aims to see how well pre-recorded guided imagery therapy sessions help children's abdominal pain when delivered via a mobile application (app) on a smartphone or tablet.\n\nParticipants will complete a baseline abdominal pain and stooling diary to determine eligibility, as well as other surveys. Eligible participants will be given access to the guided imagery therapy mobile application.\n\nThis intervention asks participants to listen to a 10- to 15-minute GIT session 5 out of 7 days per week for 8 weeks, in addition to their usual care for their abdominal pain. Then, participants will complete another abdominal pain and stooling diary, along with other psychometric surveys, at the end of this intervention period. Participants will also collect another diary and surveys 3 months post-treatment.",[543,59,58,544,545,546,26],"Functional Abdominal Pain Disorders","Gastrointestinal and Digestive Disorder","Abdominal Pain\u002F Discomfort","Pain",[548,91],"abdominal pain","2025-10-28",{"date":284,"type":34},{"date":479,"type":21},{"date":553,"type":21},"2026-11-30",{"name":555,"class":41},"Baylor College of Medicine",{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":4,"eligibilityCriteria":562,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":563,"enrollmentInfo":564,"targetDuration":4,"studyType":53,"phases":566,"briefSummary":567,"conditions":568,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":74},"100609110","press-needle-on-body-acupuncture-points-and-auricular-acupuncture-points-on-functional-dyspepsia-100609110","NCT07210294","Press Needle on Body Acupuncture Points and Auricular Acupuncture Points on Functional Dyspepsia","The Effect of Press Needle on Body Acupuncture Points and Auricular Acupuncture Points on Functional Dyspepsia","Inclusion Criteria:\n\n* Male or female aged 18-59 years\n* Patients with functional dyspepsia\n* Esophagogastroduodenoscopy (EGD) results show no significant structural abnormalities or no structural abnormalities.\n* Willing to participate in the research until completion and sign a letter of consent for medical action (informed consent).\n\nExclusion Criteria:\n\n* At the acupuncture point location there is inflammation, malignancy, and scar tissue.\n* Deformity of the earlobe.\n* History of allergies to stainless steel and plaster.\n* Medical emergencies, impaired consciousness, pregnancy, history of diabetes mellitus, and history of keloid formation.\n* History of digestive tract cancer, history of hepatobiliary cancer, history of chronic kidney failure stage 4 and 5, history of hyperthyroidism or hypothyroidism.","59 Years",{"count":565,"type":21},38,[55],"The aim of this study was to prove that press needle (PN) and medication are more effective in reducing symptoms and improving quality of life in people with functional dyspepsia compared to sham press needle (Sham PN) and medication.\n\nThe main questions this study aims to answer are:\n\n* Does the press needle and medication group reduce symptoms in people with functional dyspepsia as assessed by the Short Form-Leeds Dyspepsia Questionnaire (SF-LDQ) compared to the sham press-needle and medication group on days 7 and 14, compared to before therapy?\n* Does the press-needle and medication group improve quality of life in people with functional dyspepsia as assessed by the Short-Form Nepean Dyspepsia Index (SF-NDI) compared to the sham press-needle and medication group on days 7 and 14, compared to before therapy?\n\nA total of 38 participants were randomly allocated into two groups, either PN or Sham PN needle groups\n\nParticipants will:\n\n* Receive PN or Sham PN for 14 days and replaced on day 7.\n* Complete the SF-LDQ and SF-NDI questionnaires before therapy, on day 7, and day 14.",[26],"2025-09-29",{"date":571,"type":34},"2025-10-07",{"date":573,"type":34},"2025-08-28",{"date":575,"type":21},"2026-07-06",{"name":577,"class":41},"Indonesia University",{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":181,"sex":296,"minAge":18,"maxAge":325,"enrollmentInfo":584,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":585,"conditions":586,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":591,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":596,"locationsCount":74},"100608067","bio-electrical-impedance-analysis-in-patients-with-functional-dyspepsia-100608067","NCT07196735","Bio-electrical Impedance Analysis in Patients With Functional Dyspepsia","Inclusion Criteria:\n\n* Women aged 18 - 75 years\n* Fulfilling the ROME IV criteria for functional dyspepsia (for FD patients)\n* FD unexplained by upper GI endoscopy during the past 12 months (mild gastritis allowed) (for FD patients).\n\nExclusion Criteria:\n\n* Clinical suspicion of an organic disorder different from FD (patients can be included when this disorder had been excluded);\n* Abnormality on upper GI endoscopy other than mild gastritis (for FD patients).\n* Known reflux oesophagitis Los Angeles grade C or D, known Barrett oesophagus, peptic stricture.\n* H pylori infection, unless treated at least 6 months before;\n* Known inflammatory bowel disorder;\n* Known major intestinal motility disorder;\n* Alcohol (defined as more than 14 U per week) or other substance abuse;\n* Active psychiatric disorder;\n* Known systemic or auto-immune disorder with implication for the GI system;\n* Prior abdominal surgery (with the exception of cholecystectomy or ap-pendectomy);\n* Any prior diagnosis of cancer other than basocellular carcinoma;\n* Current chemotherapy;\n* History of gastro-enteritis in the past 12 weeks;\n* Dietary supplements unless taken at a stable dose for more than 12 weeks;\n* Treatment with neuromodulators (one neuromodulator taken at a sta-ble dose for more than 12 weeks is allowed);\n* Treatment with PPI's during the past 8 weeks\n* Pregnancy.",{"count":351,"type":21},"The primary objective of this study is to compare the BIA parameters, including Phase Angle, Fat Free Mass and Fat Mass, between women with functional dyspepsia and healthy women. All woman will undergo a bio-electrical impedance monitoring for this.",[26,587,588,589,590],"BIA","Fat Free Mass","Fat Mass","Phase Angle",{"date":592,"type":34},"2025-10-03",{"date":594,"type":34},"2025-09-18",{"date":337,"type":21},{"name":597,"class":41},"Universitair Ziekenhuis Brussel",{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":604,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":606,"targetDuration":4,"studyType":53,"phases":607,"briefSummary":608,"conditions":609,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":613,"completionDateStruct":614,"leadSponsor":616,"locationsCount":74},"100608183","phase-4-the-effects-of-stw-5-ii-on-duodenal-mucosa-and-symptoms-in-functional-dyspepsia-100608183","NCT07198243","The Effects of STW 5-II on Duodenal Mucosa and Symptoms in Functional Dyspepsia","Prospective Randomized Controlled Proof-of-concept Trial to Investigate the Effects of STW 5-II on Duodenal Mucosa and Symptoms in Functional Dyspepsia","DESTINY","Inclusion Criteria:\n\n* Patients ≥18 years newly to be treated with an FD\u002FPDS diagnosis (Rome IV clinical criteria).\n* Newly to be treated patients are defined as patients currently not on any ongoing treatment for FD (including OTC medication) for the last 2 weeks. Medications such as PPI or others that may affect GI function and symptom should be stopped prior the trial (min 4 weeks). See list of forbidden medication.\n* Male or female using contraception or postmenopausal\n* Witnessed written informed consent\n* Capable to understand and comply with the study requirements\n\nExclusion Criteria:\n\nInclusion criteria:\n\n* Patients ≥18 years newly to be treated with an FD\u002FPDS diagnosis (Rome IV clinical criteria).\n* Newly to be treated patients are defined as patients currently not on any ongoing treatment for FD (including OTC medication) for the last 2 weeks. Medications such as PPI or others that may affect GI function and symptom should be stopped prior the trial (min 4 weeks). See list of forbidden medication.\n* Male or female using contraception or postmenopausal\n* Witnessed written informed consent\n* Capable to understand and comply with the study requirements\n\nExclusion criteria:\n\n* Major active somatic or psychiatric condition that may explain dyspeptic symptoms (stable dose of single antidepressant allowed for psychiatric indication, no limitation for other indications) Predominant symptoms of gastro-esophageal reflux disease (GERD) or irritable bowel syndrome (IBS)\n* Chronic ppi use. No PPI use for at least the prior 4 weeks before entering the trial- History of major abdominal surgery (except for appendectomy, cholecystectomy or splenectomy)\n* History or presence of diabetes mellitus type 1 \\& type 2, coeliac disease or inflammatory bowel disease\n* Active malignancy\n* Known HIV, HBV or HCV infection\n* Significant alcohol use (\\>10 units\u002Fweeks)\n* Females pregnant or lactating\n* Hypersensitivity against ingredients of STW 5-II or placebo (see annex)\n* Abnormal baseline laboratory blood values",{"count":184,"type":21},[428],"The goal of this clinical trial is to find out whether a herbal medicine called STW 5-II can help improve gut health and symptoms in adults recently diagnosed with functional dyspepsia (FD)-a condition that causes frequent stomach discomfort, especially after eating.\n\nThe main questions it aims to answer are:\n\nCan STW 5-II reduce certain immune cells (eosinophils) in the gut lining? Can it improve symptoms like severe postprandial fullness, bloating, epigastric pain, and improve quality of life?\n\nResearchers will compare STW 5-II to a placebo to see if it helps reduce gut inflammation and ease symptoms.\n\nParticipants will:\n\nTake either STW 5-II or a placebo for 8 weeks Provide small samples of gut tissue (via endoscopy) Answer questions about their symptoms and daily life An optional 4-week treatment with STW 5-II will follow for all participants.",[26],"2025-09-25",{"date":612,"type":34},"2025-09-30",{"date":612,"type":21},{"date":615,"type":21},"2028-12-01",{"name":617,"class":41},"Universitaire Ziekenhuizen KU Leuven",{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":623,"acronym":4,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":625,"targetDuration":4,"studyType":53,"phases":627,"briefSummary":628,"conditions":629,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":635,"lastUpdatePostDateStruct":636,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":74},"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":626,"type":21},50,[55],"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.",[630,165,631,122,632,26,633,634],"Avoidant\u002FRestrictive Food Intake Disorder","Feeding and Eating Disorders","Appetite Regulation","Post-prandial Distress Syndrome","Behavioral Medicine","2025-09-22",{"date":610,"type":34},{"date":638,"type":34},"2022-11-30",{"date":640,"type":21},"2027-05",{"name":642,"class":41},"Massachusetts General Hospital",{"id":644,"slug":645,"hasResults":12,"nctId":646,"briefTitle":647,"officialTitle":648,"acronym":649,"eligibilityCriteria":650,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":651,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":652,"conditions":653,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":654,"lastUpdatePostDateStruct":655,"startDateStruct":657,"completionDateStruct":659,"leadSponsor":661,"locationsCount":74},"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":463,"type":21},"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.",[120,26,119],"2025-09-02",{"date":656,"type":34},"2025-09-10",{"date":658,"type":21},"2025-10",{"date":660,"type":21},"2026-07-31",{"name":617,"class":41}]