Gelsectan treatment for adults with diarrhea-predominant IBS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: thong.vd@umc.edu.vn
• Phone: +84 932039888

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Effect of Tong-Xie-Yao-Fang on diarrhea-predominant IBS

  This study is testing if a traditional Chinese medicine called Tong-Xie-Yao-Fang can help people with diarrhea-predominant irritable bowel syndrome feel better.

  Recruiting Phase 1 Xiyuan Hospital of China Academy of Chinese Medical Sciences · Beijing, Beijing Municipality · NCT06737666

• Gelsectan® for treating diarrhea-predominant irritable bowel syndrome

  This study is testing if Gelsectan® can help people with diarrhea-predominant irritable bowel syndrome feel better.

  Recruiting at 12 sites Devintec Sagl · Leuven and 11 other locations · NCT06681012

• Repeated transcranial magnetic stimulation to treat diarrhea-predominant irritable bowel syndrome

  This study will test whether repeated transcranial magnetic stimulation (rTMS) can reduce diarrhea, abdominal pain, and improve quality of life in adults with IBS-D.

  Recruiting The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07581756

• Using Transcranial Magnetic Stimulation and Probiotics to Treat IBS-D

  This study is testing if a combination of brain stimulation and probiotics can help people with diarrhea-predominant IBS feel better.

  Recruiting Phase 1 The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT06960369

• Vitamin D Supplementation in Children with Irritable Bowel Syndrome

  This study tests whether giving vitamin D to children with IBS and low vitamin D levels can improve their IBS symptoms compared with a placebo.

  Recruiting Aziz Bhatti Shaheed Teaching Hospital · Gujrat, Punjab Province · NCT07914478

• IBS-oriented Crohn's Disease Exclusion Diet versus Low FODMAP Diet for IBS

  This study tests whether an IBS-adapted Crohn's Disease Exclusion Diet (CDED) can better help adults with IBS-D or IBS-M than the low FODMAP diet.

  Recruiting Ariel University · Ramat Gan, Tel Aviv · NCT07707635

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.