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Pepto-Bismol's hidden power: reshaping your gut bugs?
NCT ID NCT05930197
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how bismuth subsalicylate (the active ingredient in Pepto-Bismol) changes the bacteria in the gut. 34 healthy adults took the medicine for 2 days, and researchers compared their stool samples before and after. The goal was to learn more about how this common stomach medicine affects the gut microbiome.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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34 people
The number who actually took part.
- Started
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Aug 2023
- Finished
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Dec 2024
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: An individual must meet all the following criteria to be eligible for this study: * Aged 18 to 50 years. * In generally good health. * Able to provide informed consent. * Willing to allow samples and data to be stored and shared for future research. * 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 the signing of the informed consent form (as early as week -18) until the final study visit. Acceptable methods of contraception include the following: * External or internal condom with spermicide. * Diaphragm or cervical cap with a spermicide. * Hormonal contraception. * Intrauterine device. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: * Use of systemic antibiotics in the last 3 months. * BSS use in the last 3 months. * Pregnant or breastfeeding. * Allergy to BSS. * Allergy to other salicylates (including aspirin). * Current use of other salicylates (including aspirin). * Current use of anticoagulant medications. * History of or active GI ulcers. * History of or active bleeding disorder. * Bloody stool within the last 3 months. * Diarrhea within the last 2 weeks (defined as three or more loose or liquid stools per day). * Current use of medications that may have a drug interaction with BSS. * Not proficient in written English. * Currently participating in another clinical trial that may affect current study procedures, per investigator s discretion. * Any condition that, in the opinion of the study team, contraindicates participation in this study. Co-enrollment in other studies is restricted. Consideration for co-enrollment in clinical trials evaluating the use of a licensed medication will require the approval of the principal investigator. Study staff should be notified of co-enrollment on any other protocol as it may require the approval of the principal investigator.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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