← Back to Search

Bismuth Subsalicylate for Gut Health in Healthy Adults

Phase 1

Recruiting

Led By Suchitra K Hourigan, M.D.

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through day 28

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how an oral medication, bismuth subsalicylate, affects the gut microbiome, gut metabolome, and host immune response.

Who is the study for?

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.

What is being tested?

The trial tests how Bismuth subsalicylate (BSS), found in over-the-counter treatments for stomach issues like Pepto-Bismol affects gut bacteria. Participants take BSS four times daily for two days and provide stool samples at each visit over up to 16 weeks. Optional blood, saliva, urine samples and colonoscopies may be involved.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects of Bismuth subsalicylate can include darkened stools or tongue due to temporary staining; nausea; constipation; rarely ringing in ears (tinnitus) especially with overdose.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through day 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through day 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and through day 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

Differences in the stool metabolome (including short chain fatty acids, bile acids, and untargeted metabolomics) pre-BSS and approximately 1 month post BSS.