Study of Gelsectan and Antispasmodic Treatments for Adults with Diarrhea-Predominant IBS Evaluating Symptom Relief and Safety in Vietnam

What this Trial Is About

This clinical trial studies adults diagnosed with diarrhea-predominant irritable bowel syndrome IBS-D in Vietnam. It evaluates the effectiveness and safety of Gelsectan, a treatment containing xyloglucan, aimed at reducing symptoms like diarrhea, abdominal pain, and bloating while improving quality of life. The research compares Gelsectan alone, Gelsectan combined with an antispasmodic medication, and antispasmodic medication alone in an open-label, randomized design. Participants will be randomly assigned to one of three groups Gelsectan monotherapy with a dosing schedule of 2 capsules twice daily for the first month and 1 capsule twice daily for the second month Gelsectan combined with a standard antispasmodic agent for eight weeks or antispasmodic therapy alone for eight weeks. The treatment period lasts two months, with assessments at baseline, one month, and two months. During the study, participants will undergo clinical evaluations of symptom remission, number of diarrhea episodes, abdominal pain and bloating intensity, and quality of life scores. Adverse events will be monitored continuously for safety. These measures will help determine the benefits and risks of Gelsectan in IBS-D, with the study concluding in July 2026.

Evaluation of the Efficacy and Safety of Gelsectan in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome