An Exploratory Study of The Effect of Bismuth Subsalicylate on The Gut Microbiome and Host Response in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- To Evaluate the Effect of BSS on the Human Gut Microbiome.
研究概览
简要总结
Background:
Many kinds of good or normal bacteria live on your skin and inside your stomach and intestines (gut). These bacteria are important to your health. What you eat, where you live, and what medicines you take can affect the bacteria in your gut. Bismuth subsalicylate (BSS) is an ingredient in common medicines for mild diarrhea and stomach pain. Products that contain BSS include Pepto-Bismol, Kao-Tin, and Pink Bismuth. But how BSS affects the bacteria in a person s gut is not fully understood.
Objective:
To see how BSS affects gut bacteria in healthy people.
Eligibility:
Healthy people aged 18 to 50 years.
Design:
Participants will have 6 clinic visits in up to 18 weeks. Only 1 visit must be at the NIH clinic; others may be either in-person or remote.
BSS is a liquid taken by mouth. Participants will take a dose of BSS 4 times a day for 2 days. They will take the same amount of BSS as a person would take to treat diarrhea or related problems.
Stool samples will be collected at each study visit. For remote visits, participants will be given a collection kit; they will collect the sample at home and send it in.
Participants will take surveys at each visit. They will answer questions about their diet and health.
Participants may also provide optional samples of blood, saliva, and urine.
Participants may have up to 2 optional colonoscopies. A long tube will be inserted via the rectum to collect tissue samples from the intestine. Participants will be sedated or placed under anesthesia for the procedure.
详细描述
Study Description:
This is a single-site, single-arm, open-label study to evaluate the effect of bismuth subsalicylate (BSS) on the human gut microbiome and host immune response. Upon confirmation of eligibility, healthy adult volunteers will provide stool and optional blood, saliva, urine, and intestinal biopsy samples for a baseline assessment of gut microbiome and host immune response. Up to 18 weeks later, participants will undergo a 2-day/8-dose regimen of oral BSS. Stool will be collected at baseline, days 2 (+3), 8 (+/-3), 14 (-3/+7) and 28 (+/-7). Blood, saliva, and urine are also optional at these time points. Participants may also undergo a second optional colonoscopy at day 8 (+/-3) to provide colon biopsies for research analysis.
Primary Objective:
To evaluate the effect of BSS on the human gut microbiome.
Secondary Objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •An individual must meet all the following criteria to be eligible for this study:
- •Aged 18 to 50 years.
- •In generally good health.
- •Able to provide informed consent.
- •Willing to allow samples and data to be stored and shared for future research.
- •Participants who can become pregnant must agree to use one effective method of contraception when engaging in sexual activities that can result in pregnancy, beginning at the signing of the informed consent form (as early as week -18) until the final study visit. Acceptable methods of contraception include the following:
- •External or internal condom with spermicide.
- •Diaphragm or cervical cap with a spermicide.
- •Hormonal contraception.
- •Intrauterine device.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Use of systemic antibiotics in the last 3 months.
- •BSS use in the last 3 months.
- •Pregnant or breastfeeding.
- •Allergy to BSS.
- •Allergy to other salicylates (including aspirin).
- •Current use of other salicylates (including aspirin).
- •Current use of anticoagulant medications.
- •History of or active GI ulcers.
- •History of or active bleeding disorder.
- •Bloody stool within the last 3 months.
- •Diarrhea within the last 2 weeks (defined as three or more loose or liquid stools per day).
- •Current use of medications that may have a drug interaction with BSS.
- •Not proficient in written English.
- •Currently participating in another clinical trial that may affect current study procedures, per investigator s discretion.
- •Any condition that, in the opinion of the study team, contraindicates participation in this study.
- •Co-enrollment in other studies is restricted. Consideration for co-enrollment in clinical trials evaluating the use of a licensed medication will require the approval of the principal investigator. Study staff should be notified of co-enrollment on any other protocol as it may require the approval of the principal investigator.
研究组 & 干预措施
Interventional
The oral suspension formulation of BSS will be used in this study. It is self administered at 1050mg 4 times per day (1 to 6 hours apart) for 2 days.
干预措施: Bismuth subsalicylate (Drug)
结局指标
主要结局
To Evaluate the Effect of BSS on the Human Gut Microbiome.
时间窗: Through Day 28
In the context of gut microbiome analysis, this measure represents the number of bacterial taxa that are significantly different between the two timepoints (baseline and 28 days post BSS) based on the read counts which represent abundance of taxa. We used shotgun metagenomic sequencing to analyze the gut microbiome. Sequenced reads were mapped to a reference database, and the read count abundance of each taxon was calculated. Statistical analysis was performed to identify the number of taxa that are significantly different between timepoints.
To Evaluate the Effect of BSS on the Human Gut Microbiome.
时间窗: Through Day 28.
Difference of alpha diversity stool samples by Shannon index at baseline (before study drug administration) and 28 days after BSS. In the context of gut microbiome analysis, the Shannon Index represents a measure of alpha diversity (measure of diversity of a microbial community). The Shannon Index is a value greater than 0 with lower values indicating lower diversity and higher values indicating higher diversity, generally between 1.5 and 3.5, and usually \< 4.5. To evaluate changes in the gut microbiome, we compared the mean change in the Shannon Index at baseline and 28 days post-BSS. Shotgun metagenomic sequencing was performed, and sequenced reads were mapped to a reference database to identify and enumerate based on read count unique taxa present in each sample. Statistical analysis was then used to determine whether there were significant differences in the Shannon Index between the two timepoints, providing insight into shifts in microbial diversity following BSS administration.
次要结局
- To Evaluate the Effect of BSS on the Human Gut Metabolome.(Through Day 28)