At a glance
ClinicalIndex Comparison Record- ✓Aged 18 to 50 years
- ✓Generally good health
- ✓Able to provide informed consent
- ✓Willing to allow samples and data to be stored and shared for future research
- ✕Systemic antibiotics use in the last 3 months
- ✕Bismuth subsalicylate use in the last 3 months
- ✕Allergy to bismuth subsalicylate
- ✕Allergy to salicylates including aspirin
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Exploratory Study of The Effect of Bismuth Subsalicylate on The Gut Microbiome and Host Response in Healthy Adults
In Brief
A Phase 1 clinical trial evaluating Bismuth subsalicylate for Healthy Adults. Completed, enrolled 34 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
BSS is a commonly used, widely available, OTC medication for a variety of gastrointestinal GI symptoms. It is available in the generic form, but also under the more commonly known brands: Bismatrol; Diotame; Geri-Pectate; Kao-Tin; Peptic Relief; Pepto-Bismol; Pink Bismuth and Stomach Relief. It received approval by the US Food and Drug Administration (FDA) in 1939.