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Trial of Rifaximin in the Treatment of Tropical Enteropathy

Primary Purpose

Tropical Enteropathy

Status
Completed
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Rifaximin
Placebo
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tropical Enteropathy

Eligibility Criteria

3 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • live in single village

Exclusion Criteria:

  • acutely malnourished
  • acutely ill
  • chronic disease

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rifaximin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 9, 2009
Last Updated
November 7, 2019
Sponsor
Washington University School of Medicine
Collaborators
Baylor College of Medicine, Kamuzu University of Health Sciences, United States Department of Agriculture (USDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00858988
Brief Title
Trial of Rifaximin in the Treatment of Tropical Enteropathy
Official Title
A Randomized, Double-blind, Placebo-controlled Trial of Rifaximin, a Non-absorbable Antibiotic, in the Treatment of Tropical Enteropathy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 2007 (Actual)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Baylor College of Medicine, Kamuzu University of Health Sciences, United States Department of Agriculture (USDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tropical Enteropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rifaximin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Intervention Description
100mg of rifaxin for 7 consecutive days, twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
twice daily for 7 consecutive days
Primary Outcome Measure Information:
Title
Difference in the Urinary L:M Ratio Before and After the Intervention
Description
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.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: live in single village Exclusion Criteria: acutely malnourished acutely ill chronic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark J Manary
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
City
Limela
Country
Malawi

12. IPD Sharing Statement

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Trial of Rifaximin in the Treatment of Tropical Enteropathy

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