Status:
RECRUITING
Evaluation of the Efficacy and Safety of Gelsectan in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome
Lead Sponsor:
University Medical Center Ho Chi Minh City (UMC)
Conditions:
Diarrhea-predominant Irritable Bowel Syndrome
Irritable Bowel Syndrome of Diarrhea Type (IBS-D)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Diarrhea-predominant irritable bowel syndrome (IBS-D) is one of the most common subtypes of IBS, accounting for approximately 30-40% of all IBS cases. In developed countries, xyloglucan-the main compo...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Diagnosis of IBS-D based on the Rome IV criteria,8 including:
- 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;
- 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
Exclusion
- Pregnant or breastfeeding women
- Known allergy to any component of the study medication
- Diagnosed with diabetes mellitus
- Patients with severe comorbidities or psychiatric disorders that impair their ability to complete questionnaires or attend follow-up visits
Key Trial Info
Start Date :
June 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07000383
Start Date
June 15 2025
End Date
March 31 2026
Last Update
June 11 2025
Active Locations (1)
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1
University Medical Center Ho Chi Minh City
Ho Chi Minh City, District 5, Vietnam, 700000