Trial of Rifaximin in the Treatment of Tropical Enteropathy

The purpose of this study is to determine whether rifaximin is effective in the treatment of tropical enteropathy in a population of African children at high risk for this disease.

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Key information

Conditions

Tropical Enteropathy Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases Sprue, Tropical

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Limela, Malawi

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

live in single village

Exclusion criteria

acutely malnourished
acutely ill
chronic disease

Treatment and study plan

Rifaximin

Drug

100mg of rifaxin for 7 consecutive days, twice daily

Placebo

Drug

twice daily for 7 consecutive days

Primary outcomes

Difference in the Urinary L:M Ratio Before and After the Intervention

Time frame: 28 days

To initiate the test, each child drank a 100 ml sugar solution containing 5 g lactulose, 1 g mannitol, 1 g sucralose, and 10 g sucrose. Children remained at the village research site for 4 h after ingestion of the sugar solution, during which time all of the child's urine was collected in a sterile cup with 10 mg merthiolate added to limit the bacterial degradation of excreted sugars. The reported values for normal L:M range from 0.03 to 0.12. A value of ≥0.10 was chosen to be indicative of tropical enteropathy. This test was performed at enrollment and then 28 days later.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

Baylor College of Medicine
Kamuzu University of Health Sciences
United States Department of Agriculture (USDA)

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Trial of Rifaximin, a Non-absorbable Antibiotic, in the Treatment of Tropical Enteropathy

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: Mar 10, 2009
Registry last updated: Nov 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed