Herbal Supplement (Biocidin REMOVE) for Bacterial Overgrowth in Irritable Bowel Syndrome

This is a single-site, randomized, double-blind, placebo-controlled pilot feasibility trial. Forty participants will be randomized 1:1 to Biocidin REMOVE or matching placebo (20 per arm). Up to 50 participants will be consented to allow for approximately 10 screen failures. Participants and investigators are both blinded; active and placebo capsules are identical in appearance.

Study product is a commercially available herbal preparation supplied as a 665 mg capsule containing 325 mg of the active proprietary blend.

Dosing follows a 9-day titration, increasing by one capsule every three days: one capsule once daily on Days -9 to -7, one capsule twice daily on Days -6 to -4, and two capsules in the morning with one in the evening on Days -3 to -1. Participants reach the target dose of two capsules twice daily on Day 1 and continue through Day 28. Titration begins approximately 14 days after the research breath test.

Baseline procedures may occur over multiple days and may begin up to 30 days before titration. Treatment-period visits carry a ±2 day window; the post-treatment follow-up visit occurs on Day 56 with a ±7 day window.

Lactulose breath testing measures carbon dioxide, hydrogen, and methane using the Quintron BreathTracker Microlyzer, performed at the Gastroenterology Clinical Laboratories at Green Spring Station. Stool is collected at home using a DNA Genotek microbiome collection kit and analyzed at Johns Hopkins. Microbiome analysis uses targeted and metagenomic sequencing of bacterial DNA to identify changes in bacterial species; beta diversity will be assessed using Bray-Curtis dissimilarity, the Jaccard index, and UniFrac. Dietary intake is captured using the ASA24 Dietary Assessment Tool.

The primary comparison of remission proportions between arms will use a two-sample z test. The sample size of 20 per arm was chosen to detect a 40 percentage-point difference in remission, assuming 10% remission without intervention and 50% with comparable interventions, using a two-sided z test with unpooled variances, alpha of 0.05, and 80% power. Baseline characteristics will be compared between arms using Student's t-tests, Wilcoxon-Mann-Whitney tests, and chi-square or Fisher exact tests as appropriate. If randomization imbalance is suggested, propensity score-based methods and/or covariate adjustment will be explored.

Adverse events are graded using NCI CTCAE version 5.0, with causality assessed as not related, possibly related, or probably related. Study drug is discontinued for any Grade 2 or greater event considered possibly or probably related, any such event persisting more than 48 hours, or any treatment-emergent serious adverse event unless clearly unrelated. The study will be stopped if three participants experience Grade 2 or greater possibly or probably related events within the same system organ class, or if one participant experiences a severe or serious event considered possibly or probably related.