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

NCT07768267 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: IRB00186116
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

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

Keywords

SIBO; IBS; Herbal supplement; Antimicrobial herbal therapy; Gut microbiome; Dysbiosis; Rome IV; Hydrogen breath test; Lactulose breath test

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With Remission of Small Intestinal Bacterial Overgrowth

  Remission is defined by a negative lactulose breath test: a rise of less than 20 parts per million of hydrogen above baseline at any timepoint in the first 90 minutes of testing, and a methane level of less than 10 parts per million at any point during the test.

  Day 28

Secondary Outcomes (3)

• Change From Baseline in Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) Score

  Baseline, Day 28, Day 56

• Change From Baseline in Gut Microbial Composition

  Baseline, Day 28

• Irritable Bowel Syndrome Quality of Life questionnaire (IBS-QOL)

  Baseline, Day 28, Day 56

Study Arms (2)

Biocidin REMOVE

EXPERIMENTAL

Participants 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.

Drug: Biocidin REMOVE

Placebo

PLACEBO COMPARATOR

Participants 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.

Drug: Placebo

Interventions

Biocidin REMOVE DRUG

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.

Also known as: Biocidin REMOVE Broad-Spectrum Liquid Capsules, Biocidin Capsules REMOVE

Biocidin REMOVE

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Biocidin: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Chedid V, Dhalla S, Clarke JO, Roland BC, Dunbar KB, Koh J, Justino E, Tomakin E, Mullin GE. Herbal therapy is equivalent to rifaximin for the treatment of small intestinal bacterial overgrowth. Glob Adv Health Med. 2014 May;3(3):16-24. doi: 10.7453/gahmj.2014.019.

  PMID: 24891990 RESULT

MeSH Terms

Conditions

Irritable Bowel Syndrome; Dysbiosis

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerry Mullin, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Datta

CONTACT

443-831-1940; jhbiocidinstudy@live.johnshopkins.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 17, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)