NCT04841980

Rifaximin Therapy vs Low FODMAP Diet In IBS

Rifaximin Therapy Versus Low FODMAP Diet In Irritable Bowel Syndrome: A Randomised Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Malaya · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Functional gastrointestinal disorders (FGIDs) are common and from the most recent global epidemiology study, an estimated 40% of the world population suffer from the condition. FGIDs cause significant morbidity to patients, despite not influencing mortality. IBS is among the most important functional gastrointestinal disorder with an estimated 3.8 to 9.2 % of the general population worldwide were affected by this disorder. Rifaximin (gut specific antibiotic) and low FODMAP diet (dietary based therapy) were proven to be effective in treating irritable bowel syndrome (IBS), however there was no head-to-head study comparing both treatments. This study will help doctors to understand the efficacy of different IBS/SIBO treatments. With the evaluation of factors that can predict treatment response, doctor could potentially treat IBS and SIBO more effectively in future. The purpose of the study is to compare the clinical symptoms and psychological improvement in patients with irritable bowel syndrome (IBS) after treatment with Rifaximin versus treatment with low FODMAP diet. The factors that is associated with treatment response will also be evaluated. In IBS patients with small intestinal bacterial overgrowth (SIBO), eradication rate of SIBO will be evaluated.

Conditions

• Irritable Bowel Syndrome
• Small Intestinal Bacterial Overgrowth

Interventions

Type	Name	Description
DRUG	Rifaximin	Administration route: PO Rifaximin 400mg TDS for 2 weeks
OTHER	Low FODMAP diet	Low FODMAP diet under dietitian guidance for 4 weeks

Timeline

• Start date: 2021-04-22
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2021-04-12
• Last updated: 2023-05-16

Locations

1 site across 1 country: Malaysia