Tier 3 — preclinical

Berberine and rifaximin effects on small intestinal bacterial overgrowth: Study protocol for an investigator-initiated, double-arm, open-label, randomized clinical trial (BRIEF-SIBO study)

Guo H, Lu S, Zhang J, Chen C, Du Y, Wang K, Duan L
Frontiers in pharmacology 2023 14:1121435

Bibliography

PubMed
PMID 36873985
PubMed Central
PMC9974661
Funding
Supported by grant JKCJ202101 from the International Institute of Population Health, Peking University Health Science Center, China. The protocol states that the funder had no design role and would have no role in trial execution, analysis, interpretation or submission.
Competing interests
Authors declare no commercial or financial relationships that could be construed as a potential conflict of interest.

Study snapshot

DesignPublished randomized-trial protocol; not an outcome report
ModelHuman participants; protocol only
Sample180 participants planned; no completed-trial outcome data in this paper
InterventionPlanned berberine 400 mg twice/day versus rifaximin 400 mg twice/day
Duration2 weeks of treatment; 6-week total follow-up planned
EndpointsPlanned primary endpoint: negative lactulose hydrogen-methane breath test; Planned secondary endpoints: abdominal symptoms and gut microbiota

What the study showed, in plain terms

The protocol specifies a breath-test endpoint and a non-inferiority design. It provides no efficacy results.

Key findings

The protocol specifies a breath-test endpoint and a non-inferiority design. It provides no efficacy results.

What this study can and cannot tell us

Protocol publication is not evidence that the trial succeeded. Conference outcome reports require separate interpretation and are not converted into a fully reported journal trial.

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