drugset / Trial / NCT03535272
Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea
Phase 3
Terminated
482 enrolled
Centers for Disease Control and Prevention
Procter and Gamble · collabThe New York Center for Travel and Tropical Medicine · collab
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2018-05-20
- Primary completion
- 2023-11-01
- Completion
- 2026-04-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bismuth subsalicylate | Small molecule | 2.1 g | Oral |