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.
Aged between 18 and 70 years, male or female.
Presenting with chief complaints of abdominal distension and/or diarrhea.
Diagnosis of small intestinal bacterial overgrowth (SIBO) confirmed by positive hydrogen-methane breath test.
Pregnant, puerperal, or breastfeeding women.
Prior history of gastrointestinal malignancy or gastrointestinal surgery.
Previously diagnosed or suspected lactose intolerance.
Severe or extremely abnormal anxiety-depression scale scores.
Parallel
Saccharomyces boulardii sachets
Drug0.5 g, orally, twice daily for 2 weeks
Rifaximin (Xifaxan)
Drug0.4 g, orally, twice daily for 2 weeks
Clinical Effective Rate After Intervention and 1 Month Post-treatment
Proportion of participants achieving clinical effectiveness, defined as complete relief, major relief or partial relief of abdominal distension and diarrhea symptoms. Clinical effective rate = (number of participants with complete relief + major relief + partial relief) / total number of participants × 100%
Symptom Relief Rate After Intervention and 1 Month Post-treatment
Symptom relief rate calculated as \[(pre-treatment total symptom score - post-treatment total symptom score) / pre-treatment total symptom score\] ×100%. Symptom scores for abdominal distension and diarrhea are assessed by 4-level scoring systems
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Total Score
GSRS is a 7-point Likert-type scale evaluating 15 gastrointestinal symptoms; total score ranges from 15 to 105, higher scores indicate more severe gastrointestinal symptoms. Change = post-treatment score minus baseline score
Incidence of Adverse Events
Proportion of participants experiencing adverse events during the 2-week treatment period. Adverse events are graded per Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Participant Treatment Adherence Rate
Treatment adherence defined as actual study drug consumption accounting for 80%-120% of prescribed dose. Adherence rate = number of participants with adequate adherence / total evaluable participants ×100%
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