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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionalExperimental Treatment1 Intervention

The oral suspension formulation of BSS will be used in this study. It is self administered at 1050mg 4 times per day (1 to 6 hours apart) for 2 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bismuth subsalicylate

2014

Completed Phase 4

~600

Do I qualify?Apply below to find out

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Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,270 Previous Clinical Trials

5,485,201 Total Patients Enrolled

1 Trials studying Healthy Adults

54 Patients Enrolled for Healthy Adults

Suchitra K Hourigan, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)

3 Previous Clinical Trials

620 Total Patients Enrolled

Media Library

Interventional Clinical Trial Eligibility Overview. Trial Name: NCT05930197 — Phase 1

Healthy Adults Research Study Groups: Interventional

Healthy Adults Clinical Trial 2023: Interventional Highlights & Side Effects. Trial Name: NCT05930197 — Phase 1

Interventional 2023 Treatment Timeline for Medical Study. Trial Name: NCT05930197 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial accept participants who are aged 70 and over?

"As per the prerequisites of this investigation, patients must be aged 18-50 in order to participate."

Answered by AI

Has Interventional received authorization from the Food and Drug Administration?

"The safety of this interventional approach is estimated to be a 1, as it has only undergone Phase 1 testing with limited data backing up its efficacy and security."

Answered by AI

What criteria must patients meet to qualify for this clinical experiment?

"To be admitted to this research, potential participants must fall within the age bracket of 18 and 50 and possess generally suitable health. As of now, 30 people are in the process of being accepted into the trial."

Answered by AI

Are there still open positions in this medical experiment?

"Clinicaltrials.gov reveals that this trial is no longer recruiting patients, having first been posted on July 9th 2023 and most recently modified on July 3rd 2023. Despite the conclusion of this study, there are still 14 other medical studies actively searching for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Effect of Bismuth Subsalicylate on the Gut Microbiome and Host Response in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05930197.