Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea

Phase 3 Terminated 482 enrolled Centers for Disease Control and Prevention Procter and Gamble · collab The 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

Outcome

Outcome not reported

Stopped: “Unable to reach target sample size.”

Publications

Gibb RD, Brum JM, Sloan KJ, Pitz AM, Circello BT, Grayling RA. Revisiting the efficacy of bismuth subsalicylate for the prevention of traveller's diarrhoea. J Travel Med. 2025 Oct 1;32(6):taaf076. doi: 10.1093/jtm/taaf076.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bismuth subsalicylate	Small molecule	2.1 g	Oral