[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"postprandial-distress-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:postprandial-distress-syndrome":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,53,78,100,123],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":4},"100640497","cognitive-behavioral-therapy-for-functional-dyspepsia-epigastric-pain-syndrome-and-postprandial-distress-syndrome-subtypes-100640497",false,"NCT07577089","Cognitive Behavioral Therapy for Functional Dyspepsia (Epigastric Pain Syndrome and Postprandial Distress Syndrome Subtypes)","Multimodal Phenotyping of Functional Dyspepsia: Controlled Trial on Response to Cognitive-Behavioral Therapy in Subtypes of Epigastric Pain Syndrome and Postprandial Discomfort Syndrome","FD-CBT","Inclusion Criteria:\n\n* Age 18-65 years\n* Diagnosis of Functional Dyspepsia according to Rome IV criteria\n* Classification as Epigastric Pain Syndrome (EPS) or Postprandial Distress Syndrome (PDS)\n* Active symptoms within the last month\n* Willingness to participate in Cognitive Behavioral Therapy and provide biological samples for research\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Presence of structural gastrointestinal disease (e.g., peptic ulcer, malignancy)\n* History of major abdominal surgery affecting the stomach or small intestine\n* Severe psychiatric disorders (e.g., psychosis, bipolar disorder) interfering with participation\n* Current participation in other interventional clinical trials\n* Use of medications that may confound study outcomes (e.g., chronic corticosteroids, immunosuppressants)\n* Pregnancy or breastfeeding","ALL","18 Years","65 Years",{"count":21,"type":22},90,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to learn whether adding Cognitive Behavioral Therapy (CBT) to standard medical treatment can improve symptoms in adults with Functional Dyspepsia. The study includes adults aged 18 to 65 years diagnosed with Functional Dyspepsia, classified as Epigastric Pain Syndrome or Postprandial Distress Syndrome.\n\nThe main questions it aims to answer are:\n\nDoes Cognitive Behavioral Therapy added to standard treatment reduce gastrointestinal symptoms compared with standard treatment alone? Do patients with Postprandial Distress Syndrome and Epigastric Pain Syndrome respond differently to Cognitive Behavioral Therapy? Researchers will compare optimized standard medical treatment alone to optimized standard treatment combined with Cognitive Behavioral Therapy to see if the addition of CBT leads to greater symptom improvement and better quality of life.\n\nParticipants will:\n\nBe randomly assigned to receive either standard medical treatment alone or standard treatment plus Cognitive Behavioral Therapy Take part in clinical visits and complete questionnaires about gastrointestinal symptoms, psychological well-being, and quality of life Provide blood, saliva, and stool samples at several time points over a 12-month follow-up period",[28,29,30],"Functional Dyspepsia","Epigastric Pain Syndrome","Postprandial Distress Syndrome",[28,32,29,30,33,34,35,36,37,38,39,40],"Cognitive Behavioral Therapy","Gut-Brain Axis","Microbiota","Randomized Controlled Trial","Disorders of Gut-Brain Interaction","Gastrointestinal Symptoms","Inflammation","Biomarkers","Precision Medicine","NOT_YET_RECRUITING","2026-05-05",{"date":44,"type":45},"2026-05-11","ACTUAL",{"date":47,"type":22},"2026-04",{"date":49,"type":22},"2028-12",{"name":51,"class":52},"Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis","OTHER",{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100569593","phase-3-a-study-of-lianxiaxiaopi-granules-in-the-treatment-of-postprandial-distress-syndrome-100569593","NCT06696261","A Study of Lianxiaxiaopi Granules in the Treatment of Postprandial Distress Syndrome","A Multicenter, Randomized, Double-blind, Placebo Parallel-controlled Phase III Clinical Trial on the Efficacy and Safety of Lianxiaxiaopi Granules in the Treatment of Postprandial Distress Syndrome (Intermingled Cold and Heat).","Inclusion Criteria:\n\n1. Age 18 to 65 years old (including boundary value), gender is not limited;\n2. meet the diagnostic criteria for postprandial distress syndrome (Rome IV.);\n3. Meet the syndrome differentiation standards of Traditional Chinese Medicine for cold and heat miscellaneous syndromes;\n4. NRS score of at least one symptom of postprandial distress syndrome (postprandial fullness, discomfort, early satiety) in the screening period and baseline period≥ 4 points; and did not have moderate\u002Fsevere epigastric pain syndrome (mid-epigastric burning sensation and mid-upper quadrant pain both \\\u003C 4 points);\n5. Those who did not have organic abnormal changes in the results of gastroscopy (including no abnormalities in gastroscopy, chronic non-atrophic gastritis\u002Fchronic superficial gastritis with erythema grade I and\u002For erosion that was flat and only grade I);\n6. Negative Helicobacter pylori test in 13C\u002F14C breath test during the screening period;\n7. Voluntarily participate in clinical trials, sign informed consent, and understand and comply with research procedures.\n\nExclusion Criteria:\n\n1. Those who have undergone Helicobacter pylori eradication treatment within 6 months before screening;\n2. Gastric mucosal erythema grade II or above, erosion is bulge or grade II or above, or accompanied by bleeding, bile reflux, ≥ 3 inflammatory polyps and other manifestations, or combined with pathological diagnosis of chronic atrophic gastritis, hyperplastic polyps, glandular polyps, etc.; or those who have been clearly diagnosed with dyspepsia caused by organic diseases of the digestive system, such as digestive tract tumors, hepatobiliary and pancreatic diseases, inflammatory bowel diseases, etc.; or those who have other diseases that affect the evaluation of dyspepsia-related symptoms in the past, such as reflux esophagitis, peptic ulcer, gastrointestinal bleeding, intestinal obstruction, etc.;\n3. Those who have been diagnosed with systemic diseases that seriously affect the function of the digestive tract, such as hyperthyroidism or hypothyroidism, diabetes, chronic renal insufficiency, connective tissue diseases, etc.;\n4. Patients with severe cardiovascular and cerebrovascular, liver, lung, kidney, blood or systemic diseases that affect their survival; or patients with severe mental illness in the past, such as moderate or severe depression\u002Fanxiety\u002Fbipolar disorder, etc.;\n5. Those who have a history of major abdominal surgery in the past, which may affect gastrointestinal function (except for appendectomy, cesarean section, endoscopic colon polyp resection and other surgeries that do not affect digestive function);\n6. Patients with abnormal liver function (ALT or AST \\>1.5 times the upper limit of normal) or abnormal renal function test (Cr\\> upper limit of normal);\n7. Glycosylated hemoglobin ≥ 6.5% or fasting blood glucose ≥7mmol\u002FL during the screening period;\n8. Use of drugs or treatments that may have an impact on the effectiveness assessment of the trial drug within 2 weeks before screening (such as acid\u002Fantacids, gastrointestinal motility drugs, digestive enzymes, gastric mucosal protectors, antiemetics, antispasmodics, macrolide antimicrobials, azole antifungals, non-steroidal anti-inflammatory drugs, glucocorticoids, anti-anxiety and depressants, analgesics, sedatives; as well as traditional Chinese medicine decoctions, proprietary Chinese medicines and acupuncture treatments for the treatment of functional dyspepsia, etc.);\n9. Pregnant and lactating women, who have a birth plan within one month after enrollment and the end of the trial;\n10. Those who suspect or have a history of alcohol or drug abuse;\n11. Participated in other clinical trials within 1 month before screening;\n12. Those who are suspected or known to be allergic to the ingredients of this medicine;\n13. According to the judgment of the investigator, it is not suitable to participate in this study.",{"count":61,"type":22},342,[63],"PHASE3","The goal of this clinical trial is evaluating the efficacy and safety of Lianxiaxiaopi Granules in participant population. The main questions it aims to answer are:\n\n1. Based on the Response rate of postprandial distress syndrome participants, evaluate whether the efficacy of Lianxiaxiaopi Granules is superior to placebo.\n2. Evaluate the efficacy of Lianxiaxiaopi Granules in improving symptom of postprandial distress syndrome.\n3. Evaluating the safety of Lianxiaxiaopi Granules in postprandial distress syndrome participants.",[30],"RECRUITING","2026-01-15",{"date":69,"type":45},"2026-01-20",{"date":71,"type":45},"2025-02-27",{"date":73,"type":22},"2026-12-31",{"name":75,"class":76},"Tasly Pharmaceutical Group Co., Ltd","INDUSTRY",18,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":4},"100606341","phase-3-acotiamide-vs-itopride-in-postprandial-distress-syndrome-100606341","NCT07174297","Acotiamide vs Itopride in Postprandial Distress Syndrome","To Compare the Efficacy and Safety of Acotiamide Versus Itopride in Patient With Post Prandial Distress Syndrome Type of Functional Dyspepsia","Inclusion Criteria:\n\n* Subjects to provide written informed consent prior to any study procedures being performed\n* Subjects with age 18-70 both male and female\n* Diagnosed with FD (PDS) by using ROME IV criteria\n* Subjects naive to acotiamide and Itopride for last 2 weeks\n* Subjects must have a normal endoscopy result within the 6 months\n\nExclusion Criteria:\n\n* Without predominant symptoms of ulcer and GERD based on history \\& endoscopy, IBS based on history \\& Rome IV criteria and Chronic idiopathic nausea based on history only\n* Subjects taking drugs that affect gut motility, gut sensitivity, SSRI and\u002For acid secretion who are unable to discontinue these drugs before initiating the intervention\n* Subjects with chronic medical disorders potentially contributing to PDS such as chronic pancreatitis, hypothyroidism, CKD and CLD identified through clinical history, physical examination, or previous medical records\n* Subjects with Type I or Type II diabetes\n* Pregnant \\& lactating mothers","70 Years",{"count":87,"type":22},152,[63],"The goal of this study is to \"To compare the efficacy and safety of Acotiamide versus Itopride in patient with post prandial distress syndrome type of functional dyspepsia\"",[30],"2025-09-18",{"date":93,"type":45},"2025-09-23",{"date":95,"type":22},"2025-10-30",{"date":97,"type":22},"2027-04-30",{"name":99,"class":76},"Getz Pharma",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"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":109,"type":22},200,"OBSERVATIONAL","Functional Dyspepsia (FD) is a common gastrointestinal disorder affecting about 7.2% of the population, characterized by gastroduodenal symptoms without an identifiable organic cause. It is divided into two subtypes based on the Rome IV criteria: (i) Postprandial Distress Syndrome (PDS): Meal-related symptoms like postprandial fullness and early satiation.; (ii) Epigastric Pain Syndrome (EPS): Meal-unrelated symptoms like epigastric pain or burning.\n\nTreatment options are limited, but prokinetics are commonly used, targeting suspected motility issues. A meta-analysis showed prokinetics reduce symptoms. Itopride, a D2 antagonist and acetylcholinesterase inhibitor, has shown potential efficacy, especially in Asian populations.\n\nAs Itopride became available in Belgium since 2023, there is a lack of real-life outcome data in Western patients with functional dyspepsia\u002Fpostprandial distress syndrome who receive treatment in standard clinical practice. Hence, the aim of this pragmatic observational study is to follow up a cohort of functional dyspepsia\u002Fpostprandial distress syndrome patients in whom itopride treatment is started as part of routine clinical practice.",[30,28,29],"2025-09-02",{"date":115,"type":45},"2025-09-10",{"date":117,"type":22},"2025-10",{"date":119,"type":22},"2026-07-31",{"name":121,"class":52},"Universitaire Ziekenhuizen KU Leuven",1,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":23,"phases":133,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":122},"100553175","phase-3-primary-care-dyspepsia-rikkunshito-100553175","NCT06482671","Primary Care dySpEpsia rikkuNshiTo","A Randomized Controlled Trial of Rikkunshito (TJ-43) in Functional Dyspepsia Patients Recruited From Primary Care","PRESENT","Inclusion Criteria:\n\n1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n2. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.\n3. Male or female\n4. 18 years old or older\n5. Newly to be treated FD diagnosis\n6. Capable to understand and comply with the study requirements\n\nExclusion Criteria:\n\n* 1\\. Participant has a history of diabetes mellitus type 1, type 2 (including therapy), eosinophilic esophagitis, coeliac disease or inflammatory bowel disease, major abdominal surgery (except for appendectomy, cholecystectomy or splenectomy).\n\n  2\\. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol 3. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial 4. If applicable: Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive 5. Patients with predominant symtoms of gastro-oesophageal reflux disease (GERD) or irritable bowel syndrome (IBS) 6. Patients with any active somatic or psychiatric condition that may explain dyspeptic symptoms (stable dose of single antidepressant allowed for psychiatric indication, no limitation for other indications) or severe depression using PHQ-7 (score of 20-27) 7. Patients already on PPI therapy20 or using a PPI in the last 2 weeks prior to enrolment 8. Patients with active malignancy (including therapy) 9. Known HIV, HBV, or HCV infection (including therapy) 10. Significant alcohol use (more than 10 units a week) 11. Known allergy to Rikkunshito or any of its ingredients 12. Patients with overweight (BMI\\>26)",{"count":132,"type":22},100,[63],"Dyspepsia refers to chronic or recurrent upper gastrointestinal (GI) symptoms originating from the gastroduodenal region with a significant impact on patients' lives. Functional dyspepsia comprises the diagnostic categories of epigastric pain syndrome (EPS) with epigastric pain or burning and postprandial distress syndrome (PDS) with meal-related fullness or early satiation, which are unexplained after routine investigation including upper GI endoscopy 2. Despite the common occurrence of FD in up to 15% of the general population, the underlying pathophysiology remains unclear and no treatments of proven efficacy are available in Europe for this condition.\n\nOur group has demonstrated increased duodenal mucosal permeability and low-grade inflammation in FD patients, correlating with meal-related symptoms. The causes of the barrier defect and immune activation are unknown but candidates include psychological stress, luminal food components, (bile) acid and microbiota. The symptoms most closely associated with increased eosinophil counts in the duodenum are early satiation and postprandial fullness, which are typical PDS symptoms, and which are also associated with impaired gastric accommodation to meal ingestion and delayed gastric emptying.\n\nPreviously the efficacy of the Kampo medicine Rikkunshito (TJ-43) has been shown in FD. The exact mode of action remains to be determined. Previous studies have provided mechanistic evidence that rikkunshito is able to improve gastric accommodation, improve food intake and enhance circulating levels of the orexigenic gut peptide ghrelin.\n\nThe aim of this study is to evaluate the efficacy of Rikkunshito in comparison to placebo in PDS patients recruited from primary care in Belgium, and to evaluate whether this is associated with changes in duodenal mucosal low-grade inflammation.",[136,30],"Dyspepsia and Other Specified Disorders of Function of Stomach","2025-07-18",{"date":139,"type":45},"2025-07-23",{"date":141,"type":45},"2024-10-01",{"date":143,"type":22},"2026-10-01",{"name":121,"class":52}]