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

Trial details

Who runs it

Johns Hopkins University

Trial code

NCT07768267

Record updated

3 November 2026

Original description

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.Read full original descriptionShow less

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)

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.

Inclusion: 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: Immunocompromised (chronic steroids, biologics), CD4 less than 400, AIDS not on therapy, neutropenia, acute and chronic leukemia, lymphoma; Poorly controlled anxiety or depression despite medication; Concurrent narcotic use; Confirmed celiac disease; Portal hypertension; Diagnosis of inflammatory bowel disease; COVID-19 positive; Connective tissue disease such as lupus or scleroderma; 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; Insulin dependent or poorly controlled diabetes mellitus (HbA1c greater than 7.0%); Negative SIBO breath testing at baseline; Restricted diets (low carbohydrate, Atkins, gluten-free, low FODMAP, or others); Pregnant or breastfeeding; Untreated significant anxiety or depression; Unable to provide informed consent; Antibiotic or probiotic use within 30 days.

ClinicalTrials.gov NCT07768267