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Sponsors and Collaborators: |
University of Virginia National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | University of Virginia |
ClinicalTrials.gov Identifier: | NCT00338221 |
This is a double blinded randomized clinical trial of Alanyl-Glutamine or Glycine in children with persistent diarrhea or malnutrition. The primary objective of the study is to determine the effect of 7 days of supplementation of alanyl-glutamine as it compares to glycine on the damaged intestinal barrier function, measured by lactulose/mannitol test on day 8, in children at HIAS in Fortaleza, Ce, Brazil, with persistent diarrhea (history > 2 weeks duration) or malnutrition.
Condition | Intervention | Phase |
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Diarrhea, Malnutrition |
Drug: alanyl-glutamine Drug: glycine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Prospective Double Blinded Randomized Clinical Trial of Alanyl-Glutamine or Glycine in Children With Persistent Diarrhea or Malnutrition |
Estimated Enrollment: | 108 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | April 2005 |
This is a double blinded randomized clinical trial of Alanyl-Glutamine or Glycine in children with persistent diarrhea or malnutrition. The primary objective of the study is to determine the effect of 7 days of supplementation of alanyl-glutamine as it compares to glycine on the damaged intestinal barrier function, measured by lactulose/mannitol test on day 8, in children at HIAS in Fortaleza, Ce, Brazil, with persistent diarrhea (history > 2 weeks duration) or malnutrition (assessed by height-for-age Z-score less than -1). Secondary objectives of the study include determining the effect of 7 days of supplementation of alanyl-glutamine or glycine on diarrhea frequency and duration; weight gain; protein loss and intestinal inflammation, and lactoferrin excretion; and weight gain at 2-4 weeks after treatment. One hundred and eight children who meet the inclusion criteria will be prospectively randomized to one of two treatment groups: (1) Glycine or (2) Alanyl-Glutamine. All children will be given vitamin A and Zinc supplementation; and if they have diarrhea, standard oral or IV rehydration therapy will be administered.
Ages Eligible for Study: | 3 Months to 36 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | University of Virginia ( Richard L. Guerrant, MD ) |
Study ID Numbers: | 02-039 |
Study First Received: | June 15, 2006 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00338221 |
Health Authority: | United States: Institutional Review Board |
Diarrhea, Malnutrition, Brazil |
Signs and Symptoms Diarrhea Malnutrition |
Signs and Symptoms, Digestive Glycine Nutrition Disorders |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Glycine Agents Pharmacologic Actions |