drugset / Trial / NCT04841980

Rifaximin Therapy vs Low FODMAP Diet In IBS

NCT04841980

Phase 4 Unknown 100 enrolled University of Malaya
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2021-04-22
Primary completion
2024-05-31
Completion
2024-05-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Rifaximin Other / unclassified 400 mg Oral