Effect of Bismuth Subsalicylate on the Gut Microbiome and Host Response in Healthy Adults
Status:
Recruiting
Trial end date:
2026-06-01
Target enrollment:
Participant gender:
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 16 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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)