Clinical Research Directory
Browse clinical research sites, groups, and studies.
Evaluation of the Efficacy and Safety of Gelsectan in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome
Sponsor: University Medical Center Ho Chi Minh City (UMC)
Summary
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. The 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. The 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. Results 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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2025-06-15
Completion Date
2026-03-31
Last Updated
2025-06-11
Healthy Volunteers
No
Conditions
Interventions
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.
Antispasmodic Agent
An oral antispasmodic medication, prescribed according to standard clinical practice for IBS-D.
Locations (1)
University Medical Center Ho Chi Minh City
Ho Chi Minh City, District 5, Vietnam