Actively Recruiting
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
Led by University Medical Center Ho Chi Minh City (UMC) · Updated on 2026-05-27
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Evaluation of the Efficacy and Safety of Gelsectan in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of diarrhea-predominant irritable bowel syndrome (IBS-D) based on Rome IV criteria, including recurrent abdominal pain at least one day per week in the last three months with associated changes in stool frequency or form
- 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
- Signed informed consent for study participation
You will not qualify if you...
- Pregnant or breastfeeding women
- Known allergy to any component of the study medication
- Diagnosed with diabetes mellitus
- Severe comorbidities or psychiatric disorders impairing ability to complete questionnaires or attend follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 months
Participants receive treatment with Gelsectan alone, Gelsectan combined with an antispasmodic agent, or antispasmodic therapy alone for diarrhea-predominant irritable bowel syndrome (IBS-D).
1 baseline visit and 2 follow-up visits at 1 month and 2 months
Trial Site Locations
Total: 1 location
1
University Medical Center Ho Chi Minh City
Ho Chi Minh City, District 5, Vietnam, 700000
Actively Recruiting
Research Team
A
Assoc. Professor. Thong Duy Vo, M.D. Ph.D.
Q
Qui Huu Nguyen, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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