[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dyspepsia-and-other-specified-disorders-of-function-of-stomach\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dyspepsia-and-other-specified-disorders-of-function-of-stomach":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,77,100],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100606416","phase-2-holy-basil-in-the-treatment-of-dyspepsia-100606416",false,"NCT07175272","Holy Basil in The Treatment of Dyspepsia","Evaluation of The Effect of Holy Basil in The Treatment of Patients With Dyspepsia","Inclusion Criteria:\n\n* Participants aged 18 years and older.\n* Presence of dyspeptic symptoms, assessed by the Leeds Dyspepsia Questionnaire with a score of at least 5 or higher.\n\nExclusion Criteria:\n\n* Presence of Helicobacter pylori infection.\n* Diagnosis of peptic ulcer or erosive esophagitis Los Angeles Classification grade B or greater.\n* Use of acid-suppressant therapy including proton pump inhibitors (PPIs) or histamine-2 receptor antagonists (H2RAs) that cannot be discontinued at least 2 weeks prior enrolment and during the study period.\n* Use of mucosal protective agents, such as rebamipide, sucralfate, or irsogladine that cannot be discontinued at least 4 weeks prior enrolment and during the study period.\n* History of gastric cancer or duodenal cancer.\n* Previous upper gastrointestinal surgery.\n* Current pregnancy or lactation.\n* Known allergic to the medicine.","ALL","18 Years",{"count":19,"type":20},27,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","The goal of this clinical trial is to evaluate whether holy basil extract can reduce gastric inflammation and improve symptoms in adult patients with dyspepsia.\n\nThe main questions it aims to answer are:\n\n* Does holy basil extract reduce gastric mucosal inflammation as measured by histopathology?\n* Does holy basil extract improve dyspeptic symptoms, endoscopic findings, gastric pH, duodenal eosinophil counts, and systemic inflammation (serum IL-6)?\n\nParticipants will:\n\n* Take 300 mg of holy basil extract orally once daily for 28 days\n* Complete symptom questionnaires and diaries during treatment\n* Undergo upper endoscopy with biopsy and intragastric pH monitoring before and after treatment\n* Provide blood samples for inflammatory marker measurement\n* Be monitored for safety and adverse events",[27],"Dyspepsia and Other Specified Disorders of Function of Stomach",[29,30,31],"Dyspepsia","Gastritis","Holy basil","RECRUITING","2026-03-23",{"date":35,"type":36},"2026-03-24","ACTUAL",{"date":38,"type":36},"2026-02-13",{"date":40,"type":20},"2026-12",{"name":42,"class":43},"Mahidol University","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100506885","bsgm-to-evaluate-patients-with-gi-symptoms-100506885","NCT05880199","BSGM to Evaluate Patients With GI Symptoms","Body Surface Gastric Mapping (BSGM) to Evaluate Patients With Gastrointestinal (GI) Symptoms","Inclusion Criteria for Cases\n\n1. Males or females age 8 to 25 years.\n2. Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test.\n3. Confirmed diagnosis of a Functional Gastrointestinal and\u002For Motility Disorder OR undergoing one of the following procedures as part of their clinical care at one of the participating centers:\n\n   1. HRVB\n   2. PENFS\n   3. ADM\n   4. Colonic Manometry\n   5. Pyloric Botox\n   6. Pyloric Dilation\n   7. Gastric Scintigraphy\n   8. GES\n   9. gammaCore\n4. Those with a body mass index of \\\u003C 35.\n5. Parental\u002Fguardian permission (informed consent) and if appropriate, child assent.\n\nExclusion Criteria for Cases\n\n1. History of skin allergies or a history of extreme sensitivity to cosmetics or lotions. Currently open wounds, abrasions, infected or inflamed abdominal skin. (Please note, majority of feeding tubes can be accommodated by the array placement.)\n2. Pregnant women.\n3. Those with any condition, where fasting is not recommended by a physician.\n4. Any allergies to foods that may be present in the standardized meal that cannot be accommodated with an acceptable substitute meal.\n5. Those with physical limitations, who are not able to maintain a relaxed reclined position for the study visit duration.\n6. Those with major developmental delay or cognitive impairment, who are not able to report their symptoms\u002Ffeelings in the questionnaires.\n7. Those with GI motility disorders that are limited in the esophagus, and the gastric mapping is restricted to capture relevant data based on the investigator's discretion.\n8. Parents\u002Fguardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.\n\nInclusion Criteria for Controls\n\n1. Males or females age 8 to 25 years.\n2. Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test.\n3. Do not have an active Functional Gastrointestinal disorder (FGID) diagnosis and will not be undergoing any procedures outlined in the recruitment plan in the near future.\n4. Those with a body mass index of \\\u003C 35.\n5. Individuals may include siblings of those with FGIDs.\n6. Parental\u002Fguardian permission (informed consent) and if appropriate, child assent.\n\nExclusion Criteria for Controls\n\n1. History of skin allergies or a history of extreme sensitivity to cosmetics or lotions. Currently open wounds, abrasions, infected or inflamed abdominal skin.\n2. Pregnant women.\n3. Those with any condition, where fasting is not recommended by a physician.\n4. Allergies to foods that may be included in the standardized meal that cannot be accommodated with an acceptable substitute meal.\n5. Those with physical limitations, who are not able to maintain a relaxed reclined position for the study duration.\n6. Those with major developmental delay or cognitive impairment, who are not able to report their symptoms\u002Ffeelings in the questionnaires.\n7. Those with GI motility disorders that are limited in the esophagus, and the gastric mapping is restricted to capture relevant data based on the investigator's discretion.\n8. Parents\u002Fguardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.",true,"8 Years","25 Years",{"count":56,"type":20},685,"OBSERVATIONAL","The goal of this observational study is to learn about gastric myoelectric activity in children with GI symptoms. The main question it aims to answer is which patterns or signals are associated with GI symptoms as measured by a body surface gastric mapping (BSGM) device. Participants will have their stomach activity recorded for up to 4 hours using the BSGM device and log real-time symptoms. Researchers will compare the recordings of healthy children and children with GI symptoms to define abnormal GI patterns.",[60,61,62,27],"Gastrointestinal Motility Disorders in Children","Functional Gastrointestinal Disorders","Gastroparesis",[64,65,66],"GI motility","gastroparesis","functional dyspepsia","2026-02-06",{"date":69,"type":36},"2026-02-10",{"date":71,"type":36},"2021-10-01",{"date":73,"type":20},"2028-06-30",{"name":75,"class":43},"Children's Hospital of Philadelphia",5,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":44},"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":86,"type":20},100,[24],"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.",[27,90],"Postprandial Distress Syndrome","2025-07-18",{"date":93,"type":36},"2025-07-23",{"date":95,"type":36},"2024-10-01",{"date":97,"type":20},"2026-10-01",{"name":99,"class":43},"Universitaire Ziekenhuizen KU Leuven",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":109,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":44},"100506699","pea-in-functional-dyspepsia-100506699","NCT05877781","PEA in Functional Dyspepsia","THE EFFECT OF DIETARY SUPPLEMENTATION WITH PALMITOYLETHANOLAMIDE ON GASTROINTESTINAL SYMPTOMS IN FUNCTIONAL DYSPEPSIA PATIENTS.","Inclusion Criteria:\n\n* Patients with functional dyspepsia as diagnosed by the Rome IV criteria.\n* Subjects must provide witnessed written informed consent prior to any study procedures being performed.\n* Subjects aged 18-70 years old.\n* Male or female subjects.\n* Subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements.\n* Women of child-bearing potential agree to apply a highly effective method of birth control during the entire duration of the trial. Highly effective birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.\n\nExclusion Criteria:\n\n* Presence of a history of gastrointestinal surgery other than appendectomy and cholecystectomy.\n* Organic gastro-intestinal disease\n* Major psychiatric disorder such as major depression\n* Presence of coeliac disease, lupus, scleroderma and other systemic auto-immune disease.\n* Patients with eosinophilic esophagitis\n* Presence of diabetes mellitus\n* Active H. Pylori infection or \\\u003C 6 months after eradication\n* Predominant IBS (based on the Rome IV questionnaire)\n* Predominant GERD (based on the Rome IV questionnaire)\n* Patients taking prohibited medication\n* Females who are pregnant or lactating\n* Patients not capable to understand or be compliant with the study.","70 Years",{"count":86,"type":20},[110],"NA","The goal of this placebo controlled randomized double blind interventional study is to assess the effect of palmitoylethanolamide supplementation in patients with functional dyspepsia The main questions it aims to answer are:\n\n* The efficacy of PEA on functional dyspepsia symptoms measured using the LPDS questionnaire\n* The effect of PEA on duodenal mucosal permeability.\n\nParticipants will receive an 8-week during treatment with PEA 3x400 mg per day or placebo 3 times per day.",[27],"2024-06-28",{"date":115,"type":36},"2024-07-01",{"date":117,"type":36},"2021-11-29",{"date":119,"type":20},"2025-03-01",{"name":99,"class":43}]