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NOT YET RECRUITING
NCT07522255
PHASE3

Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders

Sponsor: Mahidol University

View on ClinicalTrials.gov

Summary

This randomized, double-blind, placebo-controlled trial will evaluate whether a 14-day course of rifaximin improves bloating in adult patients with Rome IV functional bowel disorders in whom bloating is the predominant symptom. Eligible participants with irritable bowel syndrome, functional constipation, or functional abdominal bloating/distension and bothersome bloating despite adequate bowel movement management will be assigned in a 1:1 ratio to rifaximin 550 mg three times daily or matching placebo for 2 weeks. The primary endpoint is the proportion of participants with bloating response, defined as at least a 1-point reduction from baseline in a 7-point Likert bloating score at the end of treatment.

Official title: The Effect of Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders: A Randomized Double-blind Placebo-Controlled Trial With Gut Microbiota and Intestinal Gas Analysis

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2026-04

Completion Date

2027-12

Last Updated

2026-04-13

Healthy Volunteers

No

Interventions

DRUG

Rifaximin (drug)

Participants randomized to this arm receive rifaximin 550 mg orally three times daily for 2 weeks. Allocation is randomized and double-blinded.

DRUG

Placebo

Matching placebo administered orally three times daily for 14 days.

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, Thailand