Actively Recruiting
Evaluation of the Efficacy and Safety of Gelsectan in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome
Led by University Medical Center Ho Chi Minh City (UMC) · Updated on 2025-06-11
90
Participants Needed
1
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Diagnosed with 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 symptom onset at least six months prior
- 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
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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.
CONTACT
Q
Qui Huu Nguyen, M.D.
CONTACT
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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