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A Randomised Controlled Clinical Study of Berberine and Rifaximin for Small Intestinal Bacterial Overgrowth

Berberine and rifaximin effects for small intestinal bacterial overgrowth: an investigator initiated, double-arm, open-label, randomized clinical trial - BRIFE-SIBO

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057554
Enrollment
Unknown
Registered
2022-03-15
Start date
2022-03-14
Completion date
Unknown
Last updated
2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small intestinal bacterial overgrowth

Interventions

Trial group:Berberine hydrochloride tablets, 400mg, twice a day for 14d
Control group:Rifaximin tablets, 400mg, twice a day for 14d

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age among 18-65 years old; 2. Gastrointestinal discomforts mainly abdominal pain, distension, constipation, diarrhea for over 6 months and at least one of the symptoms up to moderate or severe degree in the gastrointestinal symptom rating scale (GSRS); 3. Positive lactulose hydrogen methane breath test; 4. Voluntarily join the study and fill in the case report form, hydrogen-methane breath test, colonoscopy and blood biochemical examination; 5. Take drugs according to the required rules with good compliance.

Exclusion criteria

Exclusion criteria: 1. Gastrointestinal organic diseases detected by endoscopy; 2. Patients with severe heart, liver, lung, kidney, blood, endocrine and nervous system diseases, or severe respiratory tract, digestive tract, urinary tract infections or mental disorders; 3. Pregnant or lactating women; 4. Antibiotics and acid suppression drugs for more than 3 days during the past month; 5. Probiotics, laxative, antidiarrhetics, motivation drugs within 2 weeks; 6. Abdominal surgery history; 7. Rifamximin or rifamycin allergy.

Design outcomes

Primary

MeasureTime frame
negative lactulose hydrogen methane breath test;

Secondary

MeasureTime frame
clinical symptom remission;Improvement of GSRS scale;Changes of fecal flora;

Countries

China

Contacts

Public ContactDuan Liping

Peking University Third Hospital

Duanlp@bjmu.edu.cn+86 13901009183

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026