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Trial of Rifaximin in the Treatment of Tropical Enteropathy

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ClinicalTrials.gov Identifier: NCT00858988
Recruitment Status : Completed
First Posted : March 10, 2009
Results First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Collaborators:
Baylor College of Medicine
University of Malawi College of Medicine
United States Department of Agriculture (USDA)
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Tropical Enteropathy Drug: Rifaximin Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Trial of Rifaximin, a Non-absorbable Antibiotic, in the Treatment of Tropical Enteropathy
Actual Study Start Date : September 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Rifaximin

Arm Intervention/treatment
Experimental: Rifaximin Drug: Rifaximin
100mg of rifaxin for 7 consecutive days, twice daily

Placebo Comparator: Placebo Drug: Placebo
twice daily for 7 consecutive days




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • live in single village

Exclusion Criteria:

  • acutely malnourished
  • acutely ill
  • chronic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00858988


Locations
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Malawi
Limela, Malawi
Sponsors and Collaborators
Washington University School of Medicine
Baylor College of Medicine
University of Malawi College of Medicine
United States Department of Agriculture (USDA)
Investigators
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Principal Investigator: Mark J Manary Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00858988    
Other Study ID Numbers: MJM-rifaximin
First Posted: March 10, 2009    Key Record Dates
Results First Posted: November 12, 2019
Last Update Posted: November 12, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Intestinal Diseases
Sprue, Tropical
Gastrointestinal Diseases
Digestive System Diseases
Malabsorption Syndromes
Metabolic Diseases
Rifaximin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents