Bismuth Subsalicylate for Gut Health in Healthy Adults
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as antibiotics, BSS, salicylates (like aspirin), and anticoagulants, before participating. If you are on any of these, you may need to stop them to join the study.
What evidence supports the effectiveness of the drug Bismuth Subsalicylate for gut health?
Bismuth subsalicylate, the active ingredient in Pepto-Bismol, has been shown to reduce the severity of diarrhea and suppress Helicobacter pylori, a bacteria linked to stomach issues. It also interacts with certain dietary components to produce products active against Clostridium difficile, another gut-related bacteria.12345
Is bismuth subsalicylate safe for use in humans?
How does the drug Bismuth Subsalicylate differ from other treatments for gut health?
Bismuth Subsalicylate is unique because it combines bismuth, which has antimicrobial properties, with subsalicylate, which can reduce inflammation and irritation in the gut. This dual action may offer a novel approach to maintaining gut health compared to other treatments that typically focus on either microbial balance or inflammation alone.89101112
Research Team
Suchitra K Hourigan, M.D.
Principal Investigator
National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria
Healthy adults aged 18 to 50 who can consent and agree to use contraception if applicable. Excluded are those pregnant, breastfeeding, with recent diarrhea or bloody stools, poor English skills, on certain medications like antibiotics or anticoagulants within the last three months, using BSS recently, allergic to salicylates including aspirin, with bleeding disorders or GI ulcers.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants provide baseline stool and optional blood, saliva, urine, and intestinal biopsy samples
Treatment
Participants take BSS 4 times a day for 2 days
Follow-up
Participants are monitored for changes in gut microbiome and host response with stool and optional blood, saliva, urine, and intestinal biopsy samples collected at specified intervals
Treatment Details
Interventions
- Bismuth Subsalicylate
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor