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)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of Participants With Remission of Small Intestinal Bacterial Overgrowth
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Biocidin REMOVE (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Participants With Remission of Small Intestinal Bacterial Overgrowth
时间窗: 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.
次要结局
- 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)