Effect of Bismuth Subsalicylate on the Gut Microbiome and Host Response in Healthy Adults - Trial NCT05930197

Timeline & Enrollment

Primary Outcome

Differences in the relative abundance of taxa in stool samples pre-BSS and approximately 1 month post-BSS. Differences in microbiome metrics of alpha diversity and beta diversity will also be assessed.

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.

ICD-10 Classifications