Herbal Supplement (Biocidin REMOVE) for Bacterial Overgrowth in Irritable Bowel Syndrome
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.
Study Overview
Status
Intervention / Treatment
Detailed 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: 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 through Day 28. Titration begins approximately 14 days after the research breath test.
Baseline procedures may occur over multiple days and may begin up to 30 days before titration. Treatment-period visits carry a ±2 day window; the post-treatment follow-up visit occurs on Day 56 with a ±7 day window.
Lactulose breath testing measures carbon dioxide, hydrogen, and methane using the Quintron BreathTracker Microlyzer, performed at the Gastroenterology Clinical Laboratories at Green Spring Station. Stool is collected at home using a DNA Genotek microbiome collection kit and analyzed at Johns Hopkins. Microbiome analysis uses targeted and metagenomic sequencing of bacterial DNA to identify changes in bacterial species; beta diversity will be assessed using Bray-Curtis dissimilarity, the Jaccard index, and UniFrac. Dietary intake is captured using the ASA24 Dietary Assessment Tool.
The primary comparison of remission proportions between arms will use a two-sample z test. The sample size of 20 per arm was chosen to detect a 40 percentage-point difference in remission, assuming 10% remission without intervention and 50% with comparable interventions, using a two-sided z test with unpooled variances, alpha of 0.05, and 80% power. Baseline characteristics will be compared between arms using Student's t-tests, Wilcoxon-Mann-Whitney tests, and chi-square or Fisher exact tests as appropriate. If randomization imbalance is suggested, propensity score-based methods and/or covariate adjustment will be explored.
Adverse events are graded using NCI CTCAE version 5.0, with causality assessed as not related, possibly related, or probably related. Study drug is discontinued for any Grade 2 or greater event considered possibly or probably related, any such event persisting more than 48 hours, or any treatment-emergent serious adverse event unless clearly unrelated. The study will be stopped if three participants experience Grade 2 or greater possibly or probably related events within the same system organ class, or if one participant experiences a severe or serious event considered possibly or probably related.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Lisa Datta
- Phone Number: 443-831-1940
- Email: jhbiocidinstudy@live.johnshopkins.edu
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
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Principal Investigator:
- Gerard Mullin, MD
-
Contact:
- Lisa Datta
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 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 Criteria:
- 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
- Antibiotic or probiotic use within 30 days
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Biocidin REMOVE
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.
|
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.
Other Names:
|
|
Placebo Comparator: Placebo
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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of Participants With Remission of Small Intestinal Bacterial Overgrowth
Time Frame: Day 28
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) Score
Time Frame: Baseline, Day 28, Day 56
|
The IBS-SSS is a composite measure assessing abdominal pain, bloating and distension, satisfaction with bowel habit, and quality of life related to irritable bowel syndrome.
Score range 0-500, higher score worse severity.
|
Baseline, Day 28, Day 56
|
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Change From Baseline in Gut Microbial Composition
Time Frame: Baseline, Day 28
|
Change in gut microbial community composition, assessed by beta diversity metrics computed from targeted and metagenomic sequencing of bacterial DNA in stool.
Metrics include Bray-Curtis dissimilarity, the Jaccard index, and UniFrac distance.
Unit of measure: dissimilarity index, a unitless value ranging from 0 to 1, where higher values indicate greater difference in microbial community composition.
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Baseline, Day 28
|
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Irritable Bowel Syndrome Quality of Life questionnaire (IBS-QOL)
Time Frame: Baseline, Day 28, Day 56
|
The Irritable Bowel Syndrome Quality of Life questionnaire (IBS-QOL) is a validated, disease-specific patient-reported outcome measure assessing the impact of irritable bowel syndrome on quality of life.
Total score ranges from 0 to 100.
Higher scores indicate better quality of life.
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Baseline, Day 28, Day 56
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gerry Mullin, MD, Johns Hopkins University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00186116
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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