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NCT03535272 · ClinicalTrials.gov registry record · Phase 3
Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea
A Phase 3 study, sponsored by Centers for Disease Control and Prevention.
- Terminated
- Registry status
- Phase 3
- Development phase
- 482
- Enrollment target
NCT03535272: Clinical Trial Phase 3 study, sponsored by Centers for Disease Control and Prevention.
NCT03535272 is a Phase 3 study that was terminated before completion, run by Centers for Disease Control and Prevention. The registered enrollment target is 482 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03535272, a Phase 3 study, was terminated before completion, sponsored by Centers for Disease Control and Prevention.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 482 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if the use of prophylactic bismuth subsalicylate (BSS) has an effect on the acquisition of travelers' diarrhea (TD) or antimicrobial resistance (AMR) genes in fecal samples among international travelers who departed from the United States to South East Asia, South Central Asia, or Africa. Our hypotheses will be tested using a double-blinded, placebo controlled randomized clinical trial with participants from a pre-travel health clinic in the United States.
Primary Outcome
Incidence of travelers' diarrhea, defined as self-reported occurrence of three or more unformed stools within a 24-hour period with or without associated gastrointestinal symptoms during travel or within 10 days after return.
Interventions
- DRUG Placebo
- DRUG Bismuth subsalicylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 482 participants |
| Start Date | 2018-05-20 |
| Est. Completion | 2026-04-29 |
| Phase | Phase 3 |
Why NCT03535272 stopped before completion
NCT03535272 is an interventional study that assigns participants to a tested intervention. The registered 482 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03535272 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03535272 about?
NCT03535272 is a clinical study titled "Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea". The purpose of this study is to determine if the use of prophylactic bismuth subsalicylate (BSS) has an effect on the acquisition of travelers' diarrhea (TD) or antimicrobial resistance (AMR) genes in fecal samples among international travelers who departed from the United States to South East Asia,...
What is the current status of trial NCT03535272?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 482 participants. The study started on 2018-05-20. Estimated completion is 2026-04-29.
What interventions are being tested in trial NCT03535272?
The interventions under investigation include: Placebo (DRUG), Bismuth subsalicylate (DRUG).
Who is sponsoring clinical trial NCT03535272?
This trial is sponsored by Centers for Disease Control and Prevention, which has 139 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03535272's enrollment target sits among peer trials
482 792nd of 2000 higher than 1,209 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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