Trial of Rifaximin in the Treatment of Tropical Enteropathy

Tropical Enteropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858988
• Other study ID #: MJM-rifaximin
• Status: Completed
• Phase: N/A
• Start date: September 2007
• Est. completion date: October 2007

Study information

• Verified date: November 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

Inclusion Criteria:

• live in single village

Exclusion Criteria:

• acutely malnourished

• acutely ill

• chronic disease

Related Conditions & MeSH terms

• Intestinal Diseases
• Tropical Enteropathy

Intervention

Drug:
• Rifaximin
100mg of rifaxin for 7 consecutive days, twice daily
• Placebo
twice daily for 7 consecutive days

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Washington University School of Medicine	Baylor College of Medicine, United States Department of Agriculture (USDA), University of Malawi College of Medicine

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the Urinary L:M Ratio Before and After the Intervention	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.	28 days