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Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders

NCT07522255 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Monthira Maneerattanaporn, M.D. · Mahidol University

  • Pubet Weeranawin, M.D. · Mahidol University

  • Somchai Leelakusolvong, M.D. · Mahidol University

  • Tanawat Geeratragool, M.D. · Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-10-31
Completion
2027-12-31

Countries

  • Thailand

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07522255 on ClinicalTrials.gov