Trial of Rifaximin in the Treatment of Tropical Enteropathy

Not Applicable

Completed

• Conditions: Tropical Enteropathy
• Interventions: Drug: Placebo; Drug: Rifaximin

• Registration Number: NCT00858988
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Study First Submitted: 2009-03-09
• Study First Submitted QC: 2009-03-09
• Study First Posted: 2009-03-10
• Results First Submitted: 2018-04-30
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-07
• Last Update Submitted: 2019-11-07
• Results First Posted: 2019-11-12
• Last Update Posted: 2019-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

• live in single village

Exclusion Criteria

• acutely malnourished
• acutely ill
• chronic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Rifaximin	Rifaximin	-

Primary Outcome Measures

Name	Time	Method
Difference in the Urinary L:M Ratio Before and After the Intervention	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.