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

NCT03535272 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 482

Last updated 2026-05-22

Study results available
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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.

Conditions

  • Diarrhea Travelers
  • Antibiotic Resistant Infection

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).

Sponsors & Collaborators

Principal Investigators

  • Bradley Connor, MD · The New York Center for Travel and Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-20
Primary Completion
2023-11-01
Completion
2026-04-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03535272 on ClinicalTrials.gov