Rifaximin for Prevention of Travellers' Diarrhea

Bausch Health Americas, Inc.210 enrolled

Overview

The purpose of this study is to determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.

To determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

210

Conditions

Diarrhea

Interventions

RifaximinDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. travelling to Mexico within 72 hours of enrollment 2. read and understand English 3. in good health Exclusion Criteria: 1. acute diarrhea within previous 7 days 2. taken FQs (any drug in this class), macrolide, azalide, or trimethoprim-sulfamethoxazole within 7 days or enrollment or anytime during study. 3. taken antidiarrheal medication within 24 hours of enrollment or anytime during study.

Locations (1)

University of San Diego

Guadalajara, Jalisco, Mexico

Outcomes

Primary Outcomes

Cumulative Occurrence of Travellers' Diarrhea (TD) for Rifaximin 600 mg QD Compared to Placebo Over 14 Days of Treatment

The efficacy of 14 days of rifaximin 600 mg once daily (QD) compared with placebo when taken by healthy subjects to prevent travelers' diarrhea (TD) resulting from all causes.

Time frame: 14 days

Data from ClinicalTrials.gov

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