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

ConditionsIrritable Bowel Syndrome (IBS)Small Intestinal Bacterial Overgrowth Syndrome (SIBO)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Biocidin REMOVEExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
Day 28

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Biocidin

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: