A Pilot Study of the Role of an Antimicrobial Herbal Formulation (Biocidin REMOVE) for the Management of Small Intestinal Bacterial Overgrowth (SIBO) in Patients With Irritable Bowel Syndrome (IBS)

Quick Summary

This is a study protocol for a planned clinical trial testing whether an herbal supplement called Biocidin REMOVE can clear small intestinal bacterial overgrowth (SIBO) in adults with irritable bowel syndrome (IBS). Results are expected in 2026 and are not yet available. The study will compare the herbal treatment to placebo in 40 participants over 5 weeks of treatment.

What Was Studied

Researchers planned a pilot study to test if Biocidin REMOVE, a commercially available herbal supplement containing a 325 mg proprietary blend, can eliminate SIBO in adults with IBS. The randomized, double-blind, placebo-controlled trial will enroll 40 participants who will take either the herbal supplement or placebo capsules for approximately 5 weeks, with follow-up 4 weeks after treatment ends.

How the Study Was Conducted

Johns Hopkins University designed this single-site trial where participants will be randomly assigned 1:1 to receive either Biocidin REMOVE or identical-looking placebo capsules. Treatment involves a 9-day dose increase period (titration) followed by 28 days at the target dose of 2 capsules twice daily. SIBO will be measured using lactulose breath tests (measuring hydrogen, methane, and carbon dioxide) before and after treatment, stool samples will be collected for microbiome analysis, and participants will complete questionnaires about symptoms, quality of life, and diet. Neither participants nor researchers will know who receives active treatment versus placebo. Full methodology not publicly available — summary based on abstract only.

Key Findings

• This is a study protocol describing planned research methods — results are not yet available as the trial is expected to complete in 2026.
• The trial was designed to detect a 40 percentage-point difference in SIBO remission rates between treatment groups, with statistical power calculations assuming 10% remission with placebo and 50% remission with treatment (these are design assumptions for sample size calculation, not actual findings).
• The study will measure multiple outcomes including SIBO clearance via breath testing, IBS symptom severity, quality of life changes, and shifts in gut bacteria composition using DNA sequencing methods.