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Title: A randomized, double-blind, placebo-controlled trial of Rifaximin, a nonabsorbable antibiotic, in the treatment of tropical enteropathy

Author
item TREHAN, INDI - Washington University School Of Medicine
item SHULMAN, ROBERT - Children'S Nutrition Research Center (CNRC)
item OU, CHING-NAN - Baylor College Of Medicine
item MALETA, KENNETH - University Of Malawi
item MANARY, MARK - University Of Malawi

Submitted to: American Journal of Gastroenterology
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 4/7/2009
Publication Date: 9/1/2009
Citation: Trehan, I., Shulman, R.J., Ou, C., Maleta, K., Manary, M.J. 2009. A randomized, double-blind, placebo-controlled trial of Rifaximin, a nonabsorbable antibiotic, in the treatment of tropical enteropathy. American Journal of Gastroenterology. 104(9):2326-2333.

Interpretive Summary: Tropical enteropathy is a disorder of unknown cause associated with an abnormality in the integrity of the intestine. In order to determine if tropical enteropathy might be related to an overgrowth of bacteria in the small intestine, children aged 3 – 5 years from one village in Malawi were provided with an oral antibiotic or placebo. The children and caregivers were not aware of which treatment the children were receiving. The integrity of the intestine was measured using a simple urine sugar test. The results suggested that an overabundance of small intestinal bacteria do not play a role in tropical enteropathy.

Technical Abstract: Tropical enteropathy is characterized by an increased urinary lactulose-to-mannitol (L:M) ratio on a site-specific sugar absorption test and is associated with increased intestinal permeability and decreased nutrient absorptive capacity. The etiology of tropical enteropathy is postulated to be intestinal bacterial overgrowth. This study tested the hypothesis that treatment with a nonabsorbable, broad-spectrum antibiotic, rifaximin, reduces the L:M ratio in rural Malawian children, among whom tropical enteropathy is common. All children aged 3 – 5 years from one village were enrolled in a randomized, double-blind, placebo-controlled trial of treatment with rifaximin for 7 days. The L:M ratio was measured before and after treatment, and the change in the L:M ratio was the primary outcome. Secondary outcomes were changes in the urinary sucrose-to-lactulose (SUC:L) and sucralose-to-lactulose (SCL:L) ratios, as well as changes in the fractions of each test sugar recovered in the urine. A total of 144 children participated in this study, of whom 76% had an elevated L:M ratio on enrollment (L:M greater than or equal to 10). Children who received rifaximin did not show an improvement in their L:M ratio compared with those who received placebo (- 0.01 +/- 0.12 vs. 0.02 +/- 0.16, respectively, P = 0.51, mean +/- s.d.), nor were there significant differences between the two groups in excretion of lactulose, mannitol, sucralose, or sucrose, or in the SUC:L and SCL:L ratios. Rifaximin had no effect on the tropical enteropathy of 3 – 5-year-old Malawian children, suggesting that small-bowel bacterial overgrowth is not an important etiological factor in this condition.