[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592972":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":40,"centralContacts":41,"locations":51,"responsibleParty":77,"collaborators":40,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":40,"enrollmentInfo":89,"targetDuration":40,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":54,"whyStopped":40,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"University Medical Center Ho Chi Minh City (UMC)","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Gelsectan Monotherapy","EXPERIMENTAL","Participants receive Gelsectan alone, administered as 2 capsules in the morning and 2 capsules in the evening during the first month; then 1 capsule in the morning and 1 in the evening during the second month.",[13],"Device: Gelsectan",{"label":15,"type":10,"description":16,"interventionNames":17},"Gelsectan + Antispasmodic","Participants receive Gelsectan as above, combined with a standard dose of an antispasmodic agent for 8 weeks.",[13,18],"Drug: Antispasmodic Agent",{"label":20,"type":21,"description":22,"interventionNames":23},"Antispasmodic Only","ACTIVE_COMPARATOR","Participants receive only an antispasmodic agent (without Gelsectan) for a total duration of 8 weeks.",[18],[25,33],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","Gelsectan","Gelsectan is a medical device containing xyloglucan, pea protein, and tannins, administered orally. Dosage: 2 capsules BID during Month 1, followed by 1 capsule BID during Month 2.",[15,9],[31,32],"Xyloglucan","XG-PPT-XOS",{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","Antispasmodic Agent","An oral antispasmodic medication, prescribed according to standard clinical practice for IBS-D.",[20,15],[39],"Antispasmodic drug",null,[42,47],{"name":43,"role":44,"phone":45,"phoneExt":40,"email":46},"Assoc. Professor. Thong Duy Vo, M.D. Ph.D.","CONTACT","+84 932039888","thong.vd@umc.edu.vn",{"name":48,"role":44,"phone":49,"phoneExt":40,"email":50},"Qui Huu Nguyen, M.D.","+84 975560142","qui.nh@umc.edu.vn",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"University Medical Center Ho Chi Minh City","RECRUITING","Ho Chi Minh City","District 5","700000","Vietnam","VN",{"type":61,"coordinates":62},"Point",[63,64],106.62965,10.82302,{"lat":64,"lon":63},[67,68,69,71,74,75],{"name":43,"role":44,"phone":45,"phoneExt":40,"email":46},{"name":48,"role":44,"phone":49,"phoneExt":40,"email":50},{"name":43,"role":70,"phone":40,"phoneExt":40,"email":40},"PRINCIPAL_INVESTIGATOR",{"name":72,"role":73,"phone":40,"phoneExt":40,"email":40},"Huong Tu Lam, M.D.","SUB_INVESTIGATOR",{"name":48,"role":73,"phone":40,"phoneExt":40,"email":40},{"name":76,"role":73,"phone":40,"phoneExt":40,"email":40},"Thuy Thanh Thi Trinh, M.D.",{"type":78,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100592972","evaluation-of-the-efficacy-and-safety-of-gelsectan-in-the-treatment-of-diarrhea-predominant-irritable-bowel-syndrome-100592972",false,"NCT07000383","Evaluation of the Efficacy and Safety of Gelsectan in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome","Evaluation of the Efficacy and Safety of Gelsectan in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome at University Medical Center Ho Chi Minh City, Vietnam: a Randomized, Open-label Clinical Trial","GELIBS","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of IBS-D based on the Rome IV criteria,8 including:\n\n  * Recurrent abdominal pain occurring at least one day per week in the last three months, associated with at least two of the following: related to defecation, associated with a change in stool frequency, or associated with a change in stool form. These criteria must have been present during the last three months, with symptom onset at least six months prior to diagnosis;\n  * More than 25% of bowel movements with stool types 6 or 7 and less than 25% with stool types 1 or 2 according to the Bristol Stool Form Scale.\n* Signed informed consent for study participation\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Known allergy to any component of the study medication\n* Diagnosed with diabetes mellitus\n* Patients with severe comorbidities or psychiatric disorders that impair their ability to complete questionnaires or attend follow-up visits","ALL","18 Years",{"count":90,"type":91},90,"ESTIMATED","INTERVENTIONAL",[94],"NA","This clinical study aims to investigate the effectiveness and safety of Gelsectan, a treatment containing xyloglucan, in adults diagnosed with diarrhea-predominant irritable bowel syndrome (IBS-D) in Vietnam. IBS-D is a common digestive disorder that causes frequent diarrhea along with abdominal pain and bloating, significantly affecting patients' daily life and wellbeing.\n\nThe main goal of the study is to determine whether Gelsectan can reduce the severity of symptoms such as diarrhea, abdominal discomfort, and bloating, and improve patients' quality of life. Participants will be randomly assigned to receive either Gelsectan alone, Gelsectan combined with an antispasmodic medication, or antispasmodic medication alone. The treatment will last for two months, with regular monitoring of symptom changes and any side effects.\n\nThe investigators hypothesize that Gelsectan treatment will lead to better symptom relief and quality of life compared to standard antispasmodic treatment. The study will also carefully observe the safety profile of Gelsectan during the treatment period.\n\nResults from this study will provide important information about the potential benefits and risks of Gelsectan for Vietnamese patients with IBS-D and may contribute to improving treatment options for this condition in Vietnam.",[97,98],"Diarrhea-predominant Irritable Bowel Syndrome","Irritable Bowel Syndrome of Diarrhea Type (IBS-D)",[100,27,101,102,103,31,85],"Irritable Bowel Syndrome","Diarrhea-Predominant Irritable Bowel Syndrome","IBS-D","Irritable Bowel Syndrome of Diarrhea type","2026-05-22",{"date":106,"type":107},"2026-05-27","ACTUAL",{"date":109,"type":107},"2025-06-15",{"date":111,"type":91},"2026-07-31",{"name":5,"class":6},1]