Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMahidol University
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Rifaximin (drug)
DrugParticipants randomized to this arm receive rifaximin 550 mg orally three times daily for 2 weeks. Allocation is randomized and double-blinded.
Placebo
DrugMatching placebo administered orally three times daily for 14 days.
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: RifaximinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Bloating responder rate
Bloating responder is defined as at least a 1-point reduction from baseline to week 2 in bloating symptom severity measured using a 7-point Likert scale for bothersomeness of bloating (range 0 to 6; higher scores indicate worse symptoms). Score categories are 0 = not at all, 1 = hardly, 2 = somewhat, 3 = moderately, 4 = a good deal, 5 = a great deal, and 6 = a very great deal.
Time frame
From enrollment to the end of treatment at 2 weeksSecondary outcomes
1
Abdominal pain response rate
Abdominal pain responder is defined as at least a 1-point reduction from baseline to week 2 in abdominal pain severity measured using a 7-point Likert scale for bothersomeness of abdominal pain (range 0 to 6; higher scores indicate worse symptoms). Score categories are 0 = not at all, 1 = hardly, 2 = somewhat, 3 = moderately, 4 = a good deal, 5 = a great deal, and 6 = a very great deal.
Time frame
From enrollment to the end of treatment at 2 weeks2
Change in Global IBS Symptoms (IBS patients)
Change in IBS Symptom Severity Score (IBS-SSS) from baseline, assessing overall IBS symptom burden, abdominal pain, bloating, and bowel habit changes. The IBS-SSS scale ranges from 0 to 500, with higher scores indicating more severe IBS symptoms.
Time frame
From enrollment to the end of treatment at 2 weeks3
Change in global constipation symptoms (constipation patients)
Change in Patient Assessment of Constipation-Symptoms (PAC-SYM) score, evaluating constipation-related symptoms, including stool consistency, discomfort, and straining. The PAC-SYM scale ranges from 0 to 48, with higher scores indicating worse constipation symptoms.
Time frame
From enrollment to the end of treatment at 2 weeks4
Treatment satisfaction
Overall treatment satisfaction, measured using a Visual Analog Scale (VAS) ranging from 0 to 10: 0 = Completely Dissatisfied 10 = Completely Satisfied Higher scores indicate greater satisfaction with treatment. The difference between baseline and post-intervention scores will be analyzed.
Time frame
End of treatment at 2 weeksSponsors and contacts
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Source ClinicalTrials.gov
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