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NCT07768267
Herbal Supplement (Biocidin REMOVE) for Bacterial Overgrowth in Irritable Bowel Syndrome
Conditions: Irritable Bowel Syndrome (IBS), Small Intestinal Bacterial Overgrowth Syndrome (SIBO)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 40
Sponsor: Johns Hopkins University
Location: Johns Hopkins Hospital Baltimore Maryland
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07768267). StuddyBuddy aggregates publicly available trial information.