Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea

Last updated: April 17, 2009
Sponsor: The University of Texas Health Science Center, Houston
Overall Status: Completed

Phase

4

Condition

Colic

Stomach Discomfort

Lactose Intolerance

Treatment

N/A

Clinical Study ID

NCT00292344
TRA-04-01
  • Ages > 18
  • All Genders

Study Summary

Most cases of travelers' diarrhea are caused by bacterial pathogens which respond slowly to antibiotic treatment.The study was designed to determine the value of rapidly acting loperamide (imodium) combined with curative dose of the poorly absorbed rifaximin in travelers' diarreha treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Inclusion criteria include: IRB approval; signing of a consent form;18 years of age orolder, providing of an unformed pre-treatment stool; females must be non-pregnant andnot nursing.

Exclusion

Exclusion Criteria:

  • Exclusion criteria include: diarrhea longer than 72 hours; moderate or severedehydration, pregnancy or breast feeding, receipt of trimethoprim-sulfamethoxazole,azalide, doxycycline, or a fluoroquinolone in the past week; unstable medicalcondition; hypersensitivity to rifaximin or rifampin; fever (>100.6o F) or bloodydiarrhea.

Study Design

Total Participants: 316
Study Start date:
June 01, 2004
Estimated Completion Date:
August 31, 2005

Study Description

During short-term study, adult U.S. students in Mexico (n = 310) with acute diarrhea (≥ 3 unformed stools with enteric symptoms) were enrolled in a double-blind, randomized trial wherein they were given rifaximin 200 mg three times a day for 3 days (R) (n = 102), loperamide 4 mg initially followed by 2 mg after each unformed stool not to exceed 8 mg/day for 2 days (L) (n = 104) or both drugs in the same dosage schedule (L/R) (n = 104). The major outcome parameter was time from initiation of therapy until passage of the last unformed stool before becoming well (TLUS).

Connect with a study center

  • Universidad Autonoma de Guadalajara

    Guadalajara, Jalisco
    Mexico

    Site Not Available

  • University of Arizona, Colegio Guadalajara

    Guadalajara, Jalisco
    Mexico

    Site Not Available

  • University of San Diego at Iteso

    Guadalajara, Jalisco
    Mexico

    Site Not Available

  • Clinica Londres Morelos

    Cuernavaca, Morelos
    Mexico

    Site Not Available

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