Gelsectan for diarrhea-predominant irritable bowel syndrome in adults in Vietnam
Tests Gelsectan, alone or with an antispasmodic, in adults with diarrhea-predominant irritable bowel syndrome.
Key facts
- Who runs it
- University Medical Center Ho Chi Minh City (UMC)
- Where
- Vietnam1 site in 1 countryChoose a country to see its sites
- Trial code
- Registry title
- Evaluation of the Efficacy and Safety of Gelsectan in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome
- Status
- Recruiting
- People taking part
- 90 people, planned
- Started
- 15 Jun 2025
- Planned end
- 31 Jul 2026
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Gelsectan
- Antispasmodic Agent
- Record updated
- 27 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with irritable bowel syndrome where diarrhea is the main problem (IBS-D). It tests Gelsectan alone, with an antispasmodic medicine, or the antispasmodic alone.
- Age
- 18 years and older
- Sex
- All sexes
- Disease stage
- IBS-D diagnosed by the Rome IV criteria. Belly pain at least one day per week in the last three months, linked to bowel movements or changes in stool. Symptoms started at least six months before diagnosis. More than 25% of stools are loose or watery (Bristol types 6 or 7) and less than 25% hard (types 1 or 2).
Main reasons for not taking part
- Pregnant or breastfeeding women
- Known allergy to any part of the study medicine
- Diabetes mellitus
- Severe other illnesses or psychiatric disorders that make it hard to fill in questionnaires or attend follow-up visits
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Pregnant or breastfeeding women
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 3 groups in the trial
- Gelsectan MonotherapyTreatment being tested
Participants receive Gelsectan alone, administered as 2 capsules in the morning and 2 capsules in the evening during the first month; then 1 capsule in the morning and 1 in the evening during the second month.
Treatment: Gelsectan
- Gelsectan + AntispasmodicTreatment being tested
Participants receive Gelsectan as above, combined with a standard dose of an antispasmodic agent for 8 weeks.
Treatment: Gelsectan and Antispasmodic Agent
- Antispasmodic OnlyExisting treatment, for comparison
Participants receive only an antispasmodic agent (without Gelsectan) for a total duration of 8 weeks.
Treatment: Antispasmodic Agent
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Gelsectan for diarrhea-predominant irritable bowel syndrome in adults in VietnamGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 27 May 2026