RecruitingNot ApplicableNCT07000383

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

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


Sponsor

University Medical Center Ho Chi Minh City (UMC)

Enrollment

90 participants

Start Date

Jun 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Antispasmodic Agent and a medical device called Gelsectan for people with diarrhea-predominant irritable bowel syndrome and irritable bowel syndrome of diarrhea type (ibs-d). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEGelsectan

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.

DRUGAntispasmodic Agent

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


Locations(1)

University Medical Center Ho Chi Minh City

Ho Chi Minh City, District 5, Vietnam

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NCT07000383


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