Evaluation of the Efficacy and Safety of Gelsectan in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome

NCT07000383 | Recruiting

• 1 other identifier: DHYD612025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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 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

Irritable Bowel Syndrome of Diarrhea Type (IBS-D); Diarrhea-predominant Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome; Gelsectan; Diarrhea-Predominant Irritable Bowel Syndrome; IBS-D; Irritable Bowel Syndrome of Diarrhea type; Xyloglucan; GELIBS

Outcome Measures

Primary Outcomes (1)

• Clinical remission of IBS-D symptoms

  Defined as the resolution of diarrhea, measured as ≤ 2 bowel movements per day with stool consistency \< 5 on the Bristol Stool Form Scale, assessed at 1 and 2 months after treatment initiation.

  1 month and 2 months

Secondary Outcomes (3)

• Incidence of adverse events

  Continuous monitoring over 2 months

• IBS Severity Scoring System (IBS-SSS)

  1 month and 2 months

• IBS-related quality of life (IBS-QoL) score

  1 month and 2 months

Other Outcomes (2)

• Bloating severity

  1 month and 2 months

• Abdominal pain intensity

  1 month and 2 months

Study Arms (3)

Gelsectan Monotherapy

EXPERIMENTAL

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.

Device: Gelsectan

Gelsectan + Antispasmodic

EXPERIMENTAL

Participants receive Gelsectan as above, combined with a standard dose of an antispasmodic agent for 8 weeks.

Device: Gelsectan; Drug: Antispasmodic Agent

Antispasmodic Only

ACTIVE COMPARATOR

Participants receive only an antispasmodic agent (without Gelsectan) for a total duration of 8 weeks.

Drug: Antispasmodic Agent

Interventions

Gelsectan DEVICE

Gelsectan is a medical device containing xyloglucan, pea protein, and tannins, administered orally. Dosage: 2 capsules BID during Month 1, followed by 1 capsule BID during Month 2.

Also known as: Xyloglucan, XG-PPT-XOS

Gelsectan + Antispasmodic; Gelsectan Monotherapy

Antispasmodic Agent DRUG

An oral antispasmodic medication, prescribed according to standard clinical practice for IBS-D.

Also known as: Antispasmodic drug

Antispasmodic Only; Gelsectan + Antispasmodic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Ho Chi Minh City (UMC): lead

Study Sites (1)

University Medical Center Ho Chi Minh City

Ho Chi Minh City, District 5, 700000, Vietnam

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Parasympatholytics

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Assoc. Professor. Thong Duy Vo, M.D. Ph.D.

CONTACT

+84 932039888; thong.vd@umc.edu.vn

Qui Huu Nguyen, M.D.

CONTACT

+84 975560142; qui.nh@umc.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized into one of three parallel groups: (1) Gelsectan monotherapy, (2) Gelsectan combined with an antispasmodic agent, and (3) antispasmodic therapy alone. Each participant will remain in their assigned group for the full two-month duration of the study, with assessments conducted at baseline, one month, and two months.

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 2, 2025
• Study Start: June 15, 2025
• Primary Completion: January 31, 2026
• Study Completion: March 31, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-05

Locations

VN (1)