Herbal Supplement (Biocidin REMOVE) for Bacterial Overgrowth in Irritable Bowel Syndrome
Part of paid clinical trials in Baltimore, Maryland.
- Sponsor
- Johns Hopkins University
- Study ID
- NCT07768267
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Irritable Bowel Syndrome (IBS)
- Small Intestinal Bacterial Overgrowth Syndrome (SIBO)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Biocidin REMOVE — DRUGHerbal 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.
- Placebo — DRUGMatching 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.
Study Details
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.
Key Dates
- First listed
- Aug 17, 2026
- Start date
- Sep 1, 2026
- Status verified
- Aug 2026
- Primary completion
- Dec 31, 2026
- Completion
- Aug 10, 2027
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Biocidin REMOVEParticipants receive Biocidin REMOVE capsules, a herbal preparation supplied as a 665 mg capsule containing 325 mg of the active proprietary blend. Dosing begins with 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 at that dose through Day 28. Capsules are identical in appearance to placebo.
- Placebo Comparator: PlaceboParticipants receive matching placebo capsules, identical in appearance to Biocidin REMOVE and containing no active ingredients. Placebo follows the same 9-day titration and dosing schedule as the experimental arm: one capsule once daily on Days -9 to -7, one capsule twice daily on Days -6 to -4, two capsules in the morning with one in the evening on Days -3 to -1, then two capsules twice daily on Days 1 through 28.
Primary Outcome Measure
Proportion of Participants With Remission of Small Intestinal Bacterial Overgrowth [ Time Frame: Day 28 ]
Central Contacts
- Gerry Dr. Mullin, MD410-502-4270
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | Lisa Datta, PhD 410-933-7495 Gerard Mullin, MD (PRINCIPAL_INVESTIGATOR) |
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