Abstract | BACKGROUND: OBJECTIVE: DESIGN: Randomized, double-blind, placebo-controlled clinical trial. SETTING: Guadalajara, Mexico. PARTICIPANTS: U.S. students. INTERVENTION: On arrival in Guadalajara, Mexico, 210 U.S. adults received rifaximin (200 mg/d, 200 mg twice daily, or 200 mg 3 times daily) or placebo for 2 weeks. MEASUREMENTS: Participants were followed daily for 3 weeks for enteric disease and symptoms and daily for 5 weeks for drug side effects. Changes in intestinal coliform flora were studied. RESULTS: Travelers' diarrhea developed in 14.74% of participants taking rifaximin and 53.70% of those taking placebo (rate ratio, 0.27 [95% CI, 0.17 to 0.43]). Rifaximin provided 72% and 77% protection against travelers' diarrhea and antibiotic-treated travelers' diarrhea, respectively (P < 0.001 for both), and all rifaximin doses were superior to placebo. In the groups that did not report travelers' diarrhea, rifaximin significantly reduced the occurrence of mild diarrhea (P = 0.02) and moderate and severe intestinal problems (P = 0.009 for pain or cramps; P = 0.02 for excessive gas). Rates of adverse events were comparable in the rifaximin and placebo groups. Minimal changes in coliform flora were found during rifaximin therapy. LIMITATIONS:
Rifaximin safely prevented travelers' diarrhea in Mexico, where most cases are caused by diarrhea-producing Escherichia coli. A study is needed in Asia to determine whether rifaximin can prevent diarrhea caused by invasive bacterial pathogens. CONCLUSIONS:
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Authors | Herbert L DuPont, Zhi-Dong Jiang, Pablo C Okhuysen, Charles D Ericsson, Francisco Javier de la Cabada, Shi Ke, Margaret W DuPont, Francisco Martinez-Sandoval |
Journal | Annals of internal medicine
(Ann Intern Med)
Vol. 142
Issue 10
Pg. 805-12
(May 17 2005)
ISSN: 1539-3704 [Electronic] United States |
PMID | 15897530
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Anti-Bacterial Agents
- Placebos
- Rifamycins
- Rifaximin
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Topics |
- Adult
- Anti-Bacterial Agents
(adverse effects, pharmacokinetics, therapeutic use)
- Antibiotic Prophylaxis
- Diarrhea
(microbiology, prevention & control)
- Double-Blind Method
- Escherichia coli Infections
(prevention & control)
- Humans
- Intestinal Absorption
- Mexico
- Placebos
- Prospective Studies
- Rifamycins
(adverse effects, pharmacokinetics, therapeutic use)
- Rifaximin
- Travel
- Treatment Outcome
- United States
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