Trial of Rifaximin in the Treatment of Tropical Enteropathy
Overview
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.
Full Title of Study: “A Randomized, Double-blind, Placebo-controlled Trial of Rifaximin, a Non-absorbable Antibiotic, in the Treatment of Tropical Enteropathy”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: October 2007
Interventions
- Drug: Rifaximin
- 100mg of rifaxin for 7 consecutive days, twice daily
- Drug: Placebo
- twice daily for 7 consecutive days
Arms, Groups and Cohorts
- Experimental: Rifaximin
- Placebo Comparator: Placebo
Clinical Trial Outcome Measures
Primary Measures
- 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.
Participating in This Clinical Trial
Inclusion Criteria
- live in single village Exclusion Criteria:
- acutely malnourished – acutely ill – chronic disease
Gender Eligibility: All
Minimum Age: 3 Years
Maximum Age: 5 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Washington University School of Medicine
- Collaborator
- Baylor College of Medicine
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Mark J Manary, Principal Investigator, Washington University School of Medicine
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.