Herbal Supplement (Biocidin REMOVE) for Bacterial Overgrowth in Irritable Bowel Syndrome | NCT07768267 | Trialant

Not yet recruitingInterventionalPhase 2Updated Aug 19, 2026

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

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)

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07768267
Lead Sponsor: Johns Hopkins UniversityOTHER
Overall Status: Not yet recruiting
Study Type: Interventional
Phase: Phase 2
Enrollment: 40Estimated
Last Update Posted: Aug 19, 2026Actual
Start Date: Sep 1, 2026Estimated
Primary Completion Date: Dec 31, 2026Estimated
Completion Date: Aug 10, 2027Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: 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)
Brief Summary: The goal of this clinical trial is to learn if an herbal supplement called Biocidin REMOVE can clear small intestinal bacterial overgrowth (SIBO) in adults with irritable bowel syndrome (IBS). SIBO means there are too many bacteria in the small intestine. It can make IBS symptoms worse.

This is a small first study, called a pilot study. Its results will help researchers plan larger studies.

The main questions it aims to answer are:

Does Biocidin REMOVE clear SIBO? Does it lower IBS symptoms and improve quality of life? Does it change the mix of bacteria in the gut? Researchers will compare Biocidin REMOVE to a placebo. A placebo is a look-alike capsule that contains no active ingredients. Neither the participants nor the research team will know who gets which one. About 40 adults age 18 and older will take part.

Participants will:

Take capsules by mouth twice a day for about 5 weeks. Participants will start with a low dose and build up to 2 capsules twice a day.

Take a breath test at the start and at the end of treatment. This test checks for SIBO.

Collect a stool sample at home at the start and at the end of treatment. Answer questions about symptoms and quality of life. Report what was eaten during the study. Come back for one check-in about 4 weeks after treatment ends.

Conditions

The medical conditions and diseases this study investigates.

Irritable Bowel Syndrome (IBS)
Small Intestinal Bacterial Overgrowth Syndrome (SIBO)

Interventions

The treatments and procedures being evaluated in this study.

Biocidin REMOVE
Placebo

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Age 18 years or older

Irritable bowel syndrome by Rome IV criteria with a positive lactulose breath test for small intestinal bacterial overgrowth, defined as a rise of more than 20 parts per million of hydrogen above baseline in the first 90 minutes of testing and/or a methane level of 10 parts per million or greater at any point during the test

OR

Irritable bowel syndrome by Rome IV criteria with a lactulose breath test showing a "flat line pattern," with exhaled gas levels remaining very low (3 parts per million or less) with no spikes

Female participants of childbearing age who are sexually active with male partners must agree to use a highly effective method of contraception, such as abstinence, hormonal contraceptive, intrauterine device, or bilateral tubal occlusion

Exclusion Criteria:

Negative SIBO breath testing at baseline

Restricted diets (low carbohydrate, Atkins, gluten-free, low FODMAP, or others)

Confirmed celiac disease

Immunocompromised (chronic steroids, biologics), CD4 less than 400, AIDS not on therapy, neutropenia, acute and chronic leukemia, lymphoma

Portal hypertension

Chronic liver disease, defined as: ICD-10 known diagnoses of chronic liver disease; OR known or suspected liver cirrhosis, portal hypertension, or chronic hepatitis; OR serum AST and ALT elevation greater than 2 times the upper limit of normal with decreased serum albumin less than 4.0 g/dL within the last 6 months

Pregnant or breastfeeding

Diagnosis of inflammatory bowel disease

Poorly controlled anxiety or depression despite medication

Untreated significant anxiety or depression

COVID-19 positive

Unable to provide informed consent

Insulin dependent or poorly controlled diabetes mellitus (HbA1c greater than 7.0%)

Connective tissue disease such as lupus or scleroderma

Concurrent narcotic use

Antibiotic or probiotic use within 30 days

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts

The people to reach with questions about this study or how to join it.

Gerry Dr. Mullin, MDContact

jhbiocidinstudy@live.johnshopkins.edu410-502-4270

Locations

Where the study is run and whether each site is currently recruiting.

Johns Hopkins Hospital

Baltimore, Maryland 21287, United States

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Johns Hopkins UniversityOTHER
Collaborators

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Other registered studies that closely resemble this one.

Detailed Description

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.