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

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