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Sponsors and Collaborators: |
University of Virginia National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | University of Virginia |
ClinicalTrials.gov Identifier: | NCT00133562 |
This study will determine the effect of 7 days supplementation of alanyl-glutatime or glycine on the damaged intestinal barrier function on day 8 in children with persistent diarrhea or malnutrition.
Condition | Intervention | Phase |
Diarrhea, Malnutrition Other Nutritional Deficiencies |
Drug: Alanyl-glutamine Drug: Glycine |
Phase III |
MedlinePlus related topics: | Children's Health Diarrhea |
Drug Information available for: | Glycine Glutamine Alanylglutamine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Prospective Double Blind Randomized Clinical Trial of Alanyl-Glutamine or Glycine in Hospitalized Children With Persistent Diarrhea or Malnutrition. |
Estimated Enrollment: | 108 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | May 2006 |
The purpose of this study is to determine the effect of 7 days supplementation of alanyl-glutamine or glycine on the damaged intestinal barrier function, measured by lactulose/mannitol test on day 8, in children with persistent diarrhea or malnutrition; on diarrhea frequency and duration, weight gain, protein loss, intestinal inflammation, and lactoferrin excretion.
Ages Eligible for Study: | 3 Months to 3 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
University of Virginia |
National Institute of Allergy and Infectious Diseases (NIAID) |
Principal Investigator: | Richard L Guerrant, MD | University of Virginia |
Responsible Party: | University of Virginia ( Richard Guerrant ) |
Study ID Numbers: | 11375 |
First Received: | August 19, 2005 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00133562 |
Health Authority: | United States: Federal Government |
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