A Phase 2 interventional study of Biocidin REMOVE and Placebo in Irritable Bowel Syndrome (IBS) and Small Intestinal Bacterial Overgrowth Syndrome (SIBO), sponsored by Johns Hopkins University. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Johns Hopkins University · Phase 2, Interventional, and Treatment
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.
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.
1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.
This study's planned enrollment of 40 is below the median of 70 across 896 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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.
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.
Time frame: Day 28
Change From Baseline in Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) Score
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.
Time frame: Baseline, Day 28, Day 56
Change From Baseline in Gut Microbial Composition
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.
Time frame: Baseline, Day 28
Irritable Bowel Syndrome Quality of Life questionnaire (IBS-QOL)
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.
Time frame: Baseline, Day 28, Day 56
Plan to share: No — Individual participant data will not be shared. The Institutional Review Board (IRB) approved protocol specifies that no person-level data, including de-identified data and limited data sets, will be sent outside the Johns Hopkins Health System or School of Medicine, and that no participant identifiers will be shared with the sponsor. Study data are stored on approved institutional platforms (REDCap, SAFE Desktop, and OneDrive) and accessed by study team members on a need-to-know basis.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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