Trial of Rifaximin in the Treatment of Tropical Enteropathy

This study has been completed.

First Received: March 9, 2009 No Changes Posted

Sponsors and Collaborators:	Washington University School of Medicine Baylor College of Medicine University of Malawi College of Medicine United States Department of Agriculture
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00858988

Purpose

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	Intervention
Tropical Enteropathy	Drug: Rifaximin

Drug Information available for: Rifaximin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Trial of Rifaximin, a Non-Absorbable Antibiotic, in the Treatment of Tropical Enteropathy

Further study details as provided by Washington University School of Medicine:

Arms	Assigned Interventions
Rifaximin: Experimental	Drug: Rifaximin
Placebo: Placebo Comparator	Drug: Rifaximin

Eligibility

Ages Eligible for Study:	3 Years to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

live in single village

Exclusion Criteria:

acutely malnourished
acutely ill
chronic disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858988

Locations

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

Investigators

Principal Investigator:

Mark J Manary

Washington University School of Medicine

More Information

No publications provided

Responsible Party:	Washington University ( Mark J. Manary )
Study ID Numbers:	MJM-rifaximin
Study First Received:	March 9, 2009
Last Updated:	March 9, 2009
ClinicalTrials.gov Identifier:	NCT00858988 History of Changes
Health Authority:	United States: Institutional Review Board; Malawi: College of Medicine Research and Ethics Committee

Study placed in the following topic categories:

Anti-Bacterial Agents
Metabolic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Sprue, Tropical

Malabsorption Syndromes
Rifaximin
Intestinal Diseases
Metabolic Disorder
Tropical Sprue

Additional relevant MeSH terms:

Anti-Infective Agents
Metabolic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Therapeutic Uses
Gastrointestinal Agents

Sprue, Tropical
Malabsorption Syndromes
Rifaximin
Intestinal Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009