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Rifaximin Versus Placebo in the Prevention of Travelers' Diarrhea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00098384
Recruitment Status : Completed
First Posted : December 8, 2004
Last Update Posted : May 9, 2006
Bausch Health Americas, Inc.
The University of Texas Health Science Center, Houston
Information provided by:
DuPont, Hurbert L., MD

Brief Summary:
The purpose of this study is to evaluate the effectiveness of poorly absorbed rifaximin in the prevention of travelers' diarrhea among U.S. college students in Mexico for five weeks.

Condition or disease Intervention/treatment Phase
Diarrhea Drug: rifaximin Phase 2

Detailed Description:
This is an investigator-initiated proposal wherein 220 male and female subjects >17 years of age from industrialized regions were randomized to receive a poorly absorbed antibiotic, rifaximin, in one of three doses at mealtime (when they are exposed to diarrhea-causing bacteria), 200 mg once a day, 200 mg twice a day or 200 mg three times a day versus a placebo starting on arrival (within the first 72 hours) to Mexico and continuing for two weeks with diaries of symptoms recorded for three weeks. Adverse events in the subjects were followed for five weeks. If mild diarrhea (1 or 2 unformed stools/24 hours plus an enteric symptom) or diarrheal illness (>2 unformed stools/24 hours plus an enteric symptom) developed, subjects provided a stool sample to determine cause of illness. Forty subjects provided stool samples after 7 days and 14 days treatment to see if their intestinal bacterial flora had developed resistance to rifaximin and to see the level of drug achieved. Stool samples from these forty subjects were studied for enteric pathogens to look for asymptomatic infection during the period of prophylaxis. The stool samples collected were initially processed in our enteric laboratories in Guadalajara, Mexico. Specialized tests such as studies of toxigenicity for enterotoxigenic E. coli and enteroadherence for enteroaggregative E. coli were done in Houston.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Single Center, Comparative Dose Ranging Study of Rifaximin Vs. Placebo in the Prevention of Travelers' Diarrhea Due to Enteropathogenic Bacteria
Study Start Date : June 2003
Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
Drug Information available for: Rifaximin

Primary Outcome Measures :
  1. Occurrence of diarrhea, defined as passage of >2 unformed stools/24 hr plus one or more signs or symptoms of enteric infection

Secondary Outcome Measures :
  1. Occurrence of mild diarrhea (1 or 2 unformed stools/24 hr plus a sign or symptom)
  2. Treatment failure (not well in five days)
  3. Occurrence of moderate to severe abdominal pain/cramps or intestinal gas related symptoms

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • An Investigational Review Board approved, written informed consent is appropriately witnessed, signed and dated prior to any study-related activities
  • Male or female subjects 18 years of age or older
  • Able to read and understand English
  • Enrolled and started on prophylaxis within 72 hours of arrival in Mexico
  • If the subject is female, only women with non-childbearing potential or those who are not pregnant will be eligible. Urine pregnancy tests will be performed on those women who question their pregnancy status. Women on the study are required to employ a reliable method of contraception while taking medication. Forms of acceptable contraception include:

    • Double barrier method of contraception.
    • Oral birth control pills for at least two cycles before enrollment and continuing during therapy - subjects will be told they should use a barrier contraception method during the study as well.
    • Norplant inserted at least one month before enrollment.
    • An intrauterine device inserted by a qualified clinician.
    • Medroxyprogesterone acetate for a minimum of one month before study and administered for one month following study completion.
    • An approved birth control patch for at least two cycles before enrollment and continuing during therapy. OR
    • Complete abstinence from intercourse for the two weeks of medication.

Exclusion Criteria:

  • Acute diarrhea (criteria for travelers' diarrhea above) within the past week
  • Diarrhea developing within 24 hours of study enrollment
  • In Mexico for more than 72 hours
  • Receipt of one of the following classes of drugs: fluoroquinolone (any drug in class), macrolide or azalide or trimethoprim-sulfamethoxazole within the past week or during the three week study
  • Receipt of other medication to decrease the occurrence of diarrhea (e.g. bismuth subsalicylate or lactobacillus preparations)
  • For females, pregnancy or breast feeding during the three week study
  • Receipt of antidiarrheal medication (loperamide, bismuth subsalicylate, kaopectate) within 24 hours of enrollment
  • Hypersensitivity to rifaximin
  • Unstable medical condition including chronic renal failure and insulin dependent diabetes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00098384

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Universidad Autonoma de Guadalajara
Guadalajara, Jalisco, Mexico
Sponsors and Collaborators
DuPont, Hurbert L., MD
Bausch Health Americas, Inc.
The University of Texas Health Science Center, Houston
Publications of Results:
Other Publications:
Layout table for additonal information Identifier: NCT00098384    
Other Study ID Numbers: PR 03
First Posted: December 8, 2004    Key Record Dates
Last Update Posted: May 9, 2006
Last Verified: December 2004
Keywords provided by DuPont, Hurbert L., MD:
Travelers' diarrhea
enterotoxigenic E. coli
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents