About this trial
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.
Eligibility criteria
Qualifiers
Adults aged 18 to 80 years.
Rome IV diagnosis of irritable bowel syndrome, functional constipation, or functional abdominal bloating/distension.
Bothersome bloating with baseline severity of at least 3 on a 7-point Likert scale after adequate constipation treatment, defined as stool frequency from at least 3 times/week to 3 times/day and Bristol Stool Form Scale type 3-5.
Colonoscopy, CT colonography, or barium enema performed if clinically indicated as part of standard evaluation for bowel symptoms.
Disqualifiers
History of major gastrointestinal surgery, except appendectomy or laparoscopic cholecystectomy.
Inflammatory bowel disease or other inflammatory gastrointestinal conditions.
Current use of, or inability to discontinue, medications that may affect intestinal microbiota or gas measurements, including antibiotics, proton pump inhibitors, probiotics, lactulose, NSAIDs, or metformin.
Current use of, or inability to discontinue, medications that may affect bloating symptoms, including simethicone, simethicone-containing antispasmodics, or antidiarrheal medications.
Trial design
Treatments tested in this trial
- Rifaximin (drug)
- Placebo
Treatment groups
Locations
1Sponsors and collaborators
Mahidol University
Lead sponsor