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)
Johns Hopkins University
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 c…
Interventions
- DrugBiocidin REMOVE
Herbal preparation supplied as a 665 mg capsule containing 325 mg of an active proprietary blend, taken by mouth. Participants titrate over 9 days, increasing by 1 capsule every 3 days, to a target dose of 2 capsules twice daily. The target dose is maintained from Day 1 through Day 28. Capsules are identical in appearance to a placebo and are dispensed by the Johns Hopkins Hospital Investigational Drug Service.
- DrugPlacebo
Matching placebo capsules, identical in appearance to Biocidin REMOVE and containing no active ingredients, taken by mouth on the same schedule: a 9-day titration increasing by one capsule every three days, reaching two capsules twice daily from Day 1 through Day 28.
Location
- Johns Hopkins HospitalBaltimore, Maryland