Trial of Rifaximin in the Treatment of Tropical Enteropathy

November 7, 2019 updated by: Washington University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • live in single village

Exclusion Criteria:

  • acutely malnourished
  • acutely ill
  • chronic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
twice daily for 7 consecutive days
EXPERIMENTAL: Rifaximin
Drug: Rifaximin
100mg of rifaxin for 7 consecutive days, twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Baylor College of Medicine
Kamuzu University of Health Sciences
United States Department of Agriculture (USDA)

Investigators

  • Principal Investigator: Mark J Manary, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2007

Primary Completion (ACTUAL)

October 1, 2007

Study Completion (ACTUAL)

October 1, 2007

Study Registration Dates

First Submitted

March 9, 2009

First Submitted That Met QC Criteria

March 9, 2009

First Posted (ESTIMATE)

March 10, 2009

Study Record Updates

Last Update Posted (ACTUAL)

November 12, 2019

Last Update Submitted That Met QC Criteria

November 7, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MJM-rifaximin

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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