drugset / Trial / NCT07815548

Comparison of the Efficacy of Saccharomyces Boulardii and Rifaximin in the Treatment of Small Intestinal Bacterial Overgrowth

NCT07815548 ↗

Phase 4 Not yet recruiting 222 enrolled Shandong University
RandomizedParallel-groupOpen-labelTreatment

Summary

This multicenter randomized controlled study aims to systematically evaluate the efficacy and safety of Saccharomyces boulardii sachets versus rifaximin in the treatment of small intestinal bacterial overgrowth (SIBO), with a focus on symptom relief and the impacts of anxiety-depressive factors on the treatment of abdominal distension and diarrhea in SIBO patients. The findings will offer a new non-antibiotic therapeutic option for SIBO, especially for patients with antibiotic resistance or those requiring long-term management, and lay a theoretical foundation for the clinical application of intestinal microecological regulators.

Timeline

Start
2026-09-10
Primary completion
2027-11-30
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Rifaximin Other / unclassified 0.4 g Oral
Subject Saccharomyces boulardii Other / unclassified 0.5 g Oral