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

NCT07768267 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-19

No results posted yet for this study

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

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

Interventions

DRUG

Biocidin 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.

DRUG

Placebo

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.

Sponsors & Collaborators

Principal Investigators

  • Gerry Mullin, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2026-12-31
Completion
2027-08-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07768267 on ClinicalTrials.gov