30 Participants Needed

Bismuth Subsalicylate for Gut Health in Healthy Adults

SL
SK
Overseen BySuchitra K Hourigan, M.D.
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

Bismuth subsalicylate, found in products like Pepto-Bismol, has been used safely for over 80 years. Studies show that it is well-tolerated, with low absorption of bismuth and salicylate levels below toxicity. It is considered safe for short-term use and up to 3-4 weeks of extended dosing.34567

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

SK

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

Able to provide informed consent
Participants who can become pregnant must agree to use one effective method of contraception when engaging in sexual activities that can result in pregnancy, beginning at baseline (as early as week -6) until the final study visit. Acceptable methods of contraception include external or internal condom with spermicide, diaphragm or cervical cap with a spermicide, hormonal contraception, intrauterine device.
Willing to allow samples and data to be stored and shared for future research
See 1 more

Exclusion Criteria

I am currently taking aspirin or similar medications.
Any condition that, in the opinion of the study team, contraindicates participation in this study
I am not taking any medications that could interact with BSS.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline Assessment

Participants provide baseline stool and optional blood, saliva, urine, and intestinal biopsy samples

1 week
1 visit (in-person or remote)

Treatment

Participants take BSS 4 times a day for 2 days

2 days
No additional visits required

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

4 weeks
5 visits (in-person or remote)

Treatment Details

Interventions

  • Bismuth Subsalicylate
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

Findings from Research

All three bismuth compounds (De-Noltabs, Pepto-Bismol, and Roter) significantly reduced intragastric urease activity in Helicobacter pylori-positive patients after just one day of dosing, indicating their efficacy in suppressing H. pylori.
The study found no significant difference in effectiveness among the three compounds, suggesting that their action occurs locally in the stomach rather than requiring systemic absorption of bismuth.
Comparison of one-day oral dosing with three bismuth compounds for the suppression of Helicobacter pylori assessed by the 13C-urea breath test.Prewett, EJ., Luk, YW., Fraser, AG., et al.[2019]
The addition of bismuth subsalicylate to standard triple therapy for Helicobacter pylori infection resulted in a higher eradication rate of 89.7% compared to 80% in the placebo group, indicating its efficacy in treatment.
Patients receiving bismuth subsalicylate experienced fewer adverse effects, such as abdominal pain (20.7% vs. 52% in the placebo group) and no cases of dark feces in the placebo group, suggesting a safety advantage in using bismuth subsalicylate.
[Addition of bismuth subsalicylate to triple eradication therapy for Helicobacter pylori infection: efficiency and adverse events].Hinostroza Morales, D., Díaz Ferrer, J.[2016]
Bismuth subsalicylate (BSS), found in Pepto-Bismol, can interact with dietary components to form water-soluble products that are effective against Clostridium difficile, a harmful bacteria that can cause severe gastrointestinal issues.
This study utilized mass spectrometry and the agar dilution method to demonstrate the potential of BSS in treating infections, highlighting its mechanism of action through the transformation of insoluble compounds into soluble, active forms.
Interaction of bismuth subsalicylate with fruit juices, ascorbic acid, and thiol-containing substrates to produce soluble bismuth products active against Clostridium difficile.Mahony, DE., Woods, A., Eelman, MD., et al.[2022]

References

Comparison of one-day oral dosing with three bismuth compounds for the suppression of Helicobacter pylori assessed by the 13C-urea breath test. [2019]
[Addition of bismuth subsalicylate to triple eradication therapy for Helicobacter pylori infection: efficiency and adverse events]. [2016]
Interaction of bismuth subsalicylate with fruit juices, ascorbic acid, and thiol-containing substrates to produce soluble bismuth products active against Clostridium difficile. [2022]
Prevention of traveler's diarrhea (emporiatric enteritis). Prophylactic administration of subsalicylate bismuth). [2022]
Double-blind randomized trial of bismuth subsalicylate and clindamycin for treatment of Helicobacter pylori infection. [2019]
Bismuth subsalicylate: history, chemistry, and safety. [2019]
Review article: safety of bismuth in the treatment of gastrointestinal diseases. [2019]
Sex differences in NSAID-induced perturbation of human intestinal barrier function and microbiota. [2023]
Role of intestinal bacteria in ileal ulcer formation in rats treated with a nonsteroidal antiinflammatory drug. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Capsazepine-Induced Altered Colonic Mucosal Health Limits Isomalto-oligosaccharide Action in High-Fat Diet-Fed C57BL/6J Mice. [2023]
Microbiota source impact in vitro metabolite colonic production and anti-proliferative effect of spent coffee grounds on human colon cancer cells (HT-29). [2019]
Bifidobacterium animalis ssp. lactis 420 Protects against Indomethacin-Induced Gastric Permeability in Rats. [2021]
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