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Pepto bismol may stop Travelers' diarrhea and superbugs

NCT ID NCT03535272

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether taking bismuth subsalicylate (Pepto Bismol) before and during international travel could prevent travelers' diarrhea and reduce the spread of antibiotic-resistant gut bacteria. About 482 healthy adults traveling to Asia or Africa were randomly assigned to take the drug or a placebo. The trial was terminated early, so results are incomplete, but the approach could offer a simple preventive option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bismuth subsalicylate (Pepto Bismol)
What this could lead to
If it works, this could offer a simple, over-the-counter way to prevent travelers' diarrhea and reduce the spread of antibiotic-resistant bacteria.
What could go wrong
The trial was terminated early, so results are limited. It only tested short-term use (up to 21 days) in healthy travelers, not the general public.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

482 people

The number who actually took part.

Started

May 2018

Finished

Apr 2026

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 69 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: 1. Be ≥ 18 and \<70 years of age at the time of enrollment 2. Sign an informed consent stating willingness to participate and comply with the study protocol 3. Plan on leaving for an international trip ≥7 days after their pre-travel consultation 4. Plan on traveling in country for ≥7 days but ≤21 days (21 day limit due to BSS duration recommendations and a lack of data on longer-term BSS use) 5. Traveling to either South East Asia, South Central Asia, North Africa, or Sub-Saharan Africa for at least 7 days of their itinerary 6. Be willing to complete an initial eligibility screening 7. Be willing to complete questionnaires and provide biologic specimens (stool) within 7 days of departure and within 10 days after return 8. Be willing to refrain from taking any pre-biotics, probiotic, synbiotic and/or herbal supplements throughout their study period Exclusion Criteria: 1. Are \<18 years of age or \>69 years of age 2. Are traveling in country for \<7 or \>21 days 3. Have known or suspected contraindications to taking BSS (including, but not limited to, travelers with kidney disease, diabetes, gout, a clotting disorder, or an allergy to any component of BSS) 4. Are pregnant (via self-report), are planning to become pregnant, or may become pregnant during travel (not actively using contraception and are sexually active), or are breastfeeding 5. Routinely take a medication known to interact with BSS (including, but not limited to, insulin, methotrexate, valproic acid, angiotensin-converting enzyme inhibitors, anticoagulants, or other salicylates) 6. Have taken an antibiotic in the 30 days before departure 7. Have taken any medications that may lower one's ability to fight infection (e.g., steroids, monoclonal antibodies, etc.) 8. Have previous diagnoses of immunocompromising conditions such as HIV/AIDS, complement deficiency, immunoglobulin deficiency, or undergoing active chemotherapy or participants with chronic gastrointestinal disorders, such as chronic diarrhea, irritable bowel syndrome (IBS), inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis), celiac disease, malabsorption syndromes, pancreatic insufficiency, gallbladder disease, or current gastrointestinal cancer 9. Have had diarrhea anytime in the previous 30 days, have diarrhea at the pre-travel consultation, or develop diarrhea before departure 10. Have been given doxycycline for malaria prophylaxis for the current trip (due to possible drug-drug interactions and decreased absorption of the doxycycline) 11. Have an allergy to any component of the placebo tablets

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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

  • Marina Rogova

    New York, New York, 10022, United States

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