Clinical Research Directory

Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders

Sponsor: Mahidol University

Summary

This randomized, double-blind, placebo-controlled trial will evaluate the effects of a 14-day course of rifaximin on bloating symptoms, gut microbiota, microbial metabolites, and intestinal gases in adults with Rome V irritable bowel syndrome with constipation (IBS-C) or functional abdominal bloating (FAB). Participants with predominant, bothersome bloating despite adequate bowel movement management will be randomly assigned in a 1:1 ratio to receive rifaximin 550 mg three times daily or matching placebo for 2 weeks. The primary endpoint is the proportion of participants with a bloating response, defined as at least a 1-point reduction from baseline on a 7-point Likert bloating scale at the end of treatment. Additional assessments will include other gastrointestinal symptoms, quality of life, psychological symptoms, gut microbiota diversity and composition, fecal short-chain fatty acids, plasma bile acids and gut-derived uremic toxins, and breath hydrogen and methane levels. Associations between biological changes and clinical response will also be examined.

Official title: Effects of Rifaximin on Bloating, Gut Microbiome, Metabolome, and Intestinal Gas in Patients With Irritable Bowel Syndrome With Constipation or Functional Abdominal Bloating Defined by Rome V Criteria: A Randomized, Double-Blind, Placebo-Controlled Trial

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