NCT05930197

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

An Exploratory Study of The Effect of Bismuth Subsalicylate on The Gut Microbiome and Host Response in Healthy Adults
National Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Healthy Adults
Drug/Device/Intervention
Bismuth subsalicylate
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Funder
National Institutes of Health Clinical Center (CC)
Location
Bethesda, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Aug 14, 2023
End date
Jun 01, 2026
Enrollment
30 participants
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
ObesityHealthy person accompanying sick personObesity, unspecifiedRoutine general health check-up of inhabitants of institutionsLifestyle-related condition
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05930197
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05930197 through Pure Global AI's free database. This Phase 1 trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID) and is currently Recruiting. The study focuses on Healthy Adults. Target enrollment is 30 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.