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

Phase 4Not Yet RecruitingNCT07815548

Shandong University222 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

222

Conditions

Small Intestinal Bacterial Overgrowth Syndrome (SIBO)

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged between 18 and 70 years, male or female. 2. Presenting with chief complaints of abdominal distension and/or diarrhea. 3. Diagnosis of small intestinal bacterial overgrowth (SIBO) confirmed by positive hydrogen-methane breath test. Exclusion Criteria: 1. Pregnant, puerperal, or breastfeeding women. 2. Prior history of gastrointestinal malignancy or gastrointestinal surgery. 3. Previously diagnosed or suspected lactose intolerance. 4. Severe or extremely abnormal anxiety-depression scale scores. 5. Confirmed extra-digestive system diseases, including urinary system diseases (e.g., chronic kidney disease), immune system diseases (e.g., scleroderma), nervous system diseases (e.g., Parkinson's disease), and endocrine system diseases (e.g., diabetes mellitus). 6. Use of antibiotics or microecological preparations within 2 weeks before enrollment; receiving endoscopy, enema, or colonic barium-air contrast examination within 2 weeks before enrollment; use of prokinetics, secretagogues, antifoaming agents, antispasmodics, opioids, or antidepressants within 1 week before enrollment. 7. Known allergy to study medications. 8. Immunosuppressed hospitalized patients or hospitalized patients with immune impairment due to critical illness. 9. Unable or unwilling to provide written informed consent. 10. History of psychiatric disorders. 11. Any other conditions that render the subject inappropriate for participation in this study, as judged by the investigator.

Outcomes

Primary Outcomes

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%

Time frame: End of 2-week treatment; 1 month after completion of treatment

Secondary Outcomes

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

Time frame: End of 2-week treatment; 1 month after completion of treatment

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

Time frame: Baseline, end of 2-week treatment, 1 month after completion of treatment

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)

Time frame: From first study drug administration up to 60 days after last study drug dose

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%

Time frame: Throughout the 2-week treatment period

Proportion of Participants With Comorbid Anxiety and Depression

Proportion of SIBO participants with abnormal anxiety-depression scores. Assessments include Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), Hamilton Anxiety Rating Scale (HAMA), and Hamilton Depression Rating Scale (HAMD)

Time frame: Baseline, 1 month after completion of treatment

Correlation Between Anxiety-depression Scores and Degree of Symptom Relief

Correlation analysis between baseline anxiety-depression scale scores and symptom relief rate after treatment