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TERMINATED
NCT03535272
PHASE3

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

Sponsor: Centers for Disease Control and Prevention

View on ClinicalTrials.gov

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.

Official title: Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea and Impact on Acquisition of Gut Antimicrobial Resistance Genes

Key Details

Gender

All

Age Range

18 Years - 69 Years

Study Type

INTERVENTIONAL

Enrollment

482

Start Date

2018-05-20

Completion Date

2026-04-29

Last Updated

2026-05-22

Healthy Volunteers

Yes

Interventions

DRUG

Bismuth subsalicylate

Bismuth subsalicylate administered orally as tablets (4 tablets twice daily; total daily dose approximately 2.1 g) beginning prior to arrival at the travel destination and continued throughout the duration of travel (up to 21 days).

DRUG

Placebo

Matching oral placebo tablets administered twice daily, identical in appearance, taste, and packaging to bismuth subsalicylate, given for the duration of travel (up to 21 days).

Locations (1)

Marina Rogova

New York, New York, United States