Gelsectan treatment for adults with diarrhea-predominant IBS

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

This trial tests whether Gelsectan, alone or combined with an antispasmodic, helps adults in Vietnam who have diarrhea-predominant IBS feel better and have fewer symptoms.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Medical Center Ho Chi Minh City (UMC) (other)
• Locations: 1 site (Ho Chi Minh City, District 5)
• Trial ID: NCT07000383 on ClinicalTrials.gov

What this trial studies

This is an open-label, randomized controlled trial at the University Medical Center Ho Chi Minh City comparing three 2-month treatment arms: Gelsectan alone, Gelsectan plus an antispasmodic, and an antispasmodic alone. Adults aged 18 and over with IBS-D diagnosed by Rome IV criteria will be enrolled and monitored for changes in diarrhea, abdominal pain, bloating, and quality of life at 1 and 2 months. Safety will be tracked through recording of adverse events and tolerability throughout the intervention period. The trial aims to determine both symptom benefit and the safety profile of Gelsectan in the Vietnamese patient population.

Who should consider this trial

Good fit: Adults aged 18 or older with diarrhea-predominant IBS meeting Rome IV criteria who can provide informed consent and attend follow-up visits at the Ho Chi Minh City site are ideal candidates.

Not a fit: Patients with constipation-predominant IBS, diabetes, pregnancy or breastfeeding, severe comorbidities, known allergy to study medication, or who cannot attend visits are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, Gelsectan could reduce diarrhea and abdominal symptoms and improve quality of life for adults with IBS-D.

How similar studies have performed: Previous clinical studies in other countries have shown xyloglucan-based products like Gelsectan can relieve IBS-D symptoms, but there is no published data specifically from Vietnam.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Ho Chi Minh City, District 5

• University Medical Center Ho Chi Minh City — Ho Chi Minh City, District 5, Vietnam (RECRUITING)

Study contacts

• Study coordinator: Assoc. Professor. Thong Duy Vo, M.D. Ph.D.

Conditions: Diarrhea-predominant Irritable Bowel Syndrome, Irritable Bowel Syndrome of Diarrhea Type, Irritable Bowel Syndrome, Gelsectan, Diarrhea-Predominant Irritable Bowel Syndrome, IBS-D, Irritable Bowel Syndrome of Diarrhea type, Xyloglucan