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A randomized, double-blind, placebo-controlled trial of rifaximin to prevent travelers' diarrhea.

Abstract：

BACKGROUND:Travelers' diarrhea causes substantial morbidity and postinfectious irritable bowel syndrome. OBJECTIVE:To evaluate nonabsorbable rifaximin for prevention of travelers' diarrhea. 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:Rifaximin prevents travelers' diarrhea with minimal changes in fecal flora, and more liberal chemoprophylaxis against this disease should be considered. Future studies should evaluate whether rifaximin is effective in preventing postinfectious irritable bowel syndrome.

journal_name

Ann Intern Med

journal_title

Annals of internal medicine

authors

DuPont HL,Jiang ZD,Okhuysen PC,Ericsson CD,de la Cabada FJ,Ke S,DuPont MW,Martinez-Sandoval F

doi

10.7326/0003-4819-142-10-200505170-00005

subject

Has Abstract

pub_date

2005-05-17 00:00:00

pages

805-12

issue

eissn

0003-4819

issn

1539-3704

pii

142/10/805

journal_volume

142

pub_type

临床试验,杂志文章,随机对照试验

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A randomized, double-blind, placebo-controlled trial of rifaximin to prevent travelers' diarrhea.