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Clinical Trial of Alanyl-Glutamine or Glycine in Children With Persistent Diarrhea or Malnutrition

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00338221
First received: June 15, 2006
Last updated: October 27, 2008
Last verified: October 2008
History of Changes
  Purpose

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
Diarrhea, Malnutrition
 Drug: alanyl-glutamine
Drug: glycine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Prospective Double Blinded Randomized Clinical Trial of Alanyl-Glutamine or Glycine in Children With Persistent Diarrhea or Malnutrition

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Virginia:

Estimated Enrollment: 108
Study Start Date: August 2004
Estimated Study Completion Date: April 2005
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   3 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children ages 3 to 36 months with a history of persistent diarrhea (3 or more unformed stools/day) for > 2 weeks or height-for-age Z-score (HAZ) less than -1, which is the median of HAZ scores in children at HIAS.
  2. Be an inpatient and willing to stay for 7 nights at HIAS.
  3. Child's parent or guardian must sign informed consent.

Exclusion Criteria:

  1. Children exclusively breast-fed (Reason: The diet needs to be controlled in order to evaluate the study treatment effect)
  2. Children who participated in the "community study" or any other study within the past two years (Reason: The children in the "community study" will have received glutamine.)
  3. Children with suspected other illnesses as indicated by fever >102 degrees F at time of screening off antipyretics.
  4. Children with suspected systemic disease at the time of screening including but not limited to shock, meningitis, sepsis, pneumonia, tuberculosis, varicella
  5. Severe malnutrition defined as HAZ <-3.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00338221

Sponsors and Collaborators
University of Virginia
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Richard L Guerrrant, MD University of Virginia
  More Information

No publications provided

Responsible Party: Richard L. Guerrant, MD, University of Virginia
ClinicalTrials.gov Identifier: NCT00338221     History of Changes
Other Study ID Numbers: 02-039
Study First Received: June 15, 2006
Last Updated: October 27, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
Diarrhea, Malnutrition, Brazil

Additional relevant MeSH terms:
Diarrhea
Malnutrition
Signs and Symptoms, Digestive
Signs and Symptoms
Nutrition Disorders
Glycine
 Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013