Clinical Trial of Alanyl-Glutamine or Glycine in Children With Persistent Diarrhea or Malnutrition
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diarrhea, Malnutrition
Intervention: alanyl-glutamine (Drug); glycine (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Summary
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.
Clinical Details
Official title: Prospective Double Blinded Randomized Clinical Trial of Alanyl-Glutamine or Glycine in Children With Persistent Diarrhea or Malnutrition
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
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
Minimum age: 3 Months.
Maximum age: 36 Months.
Gender(s): Both.
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.
Locations and Contacts
Hospital Infantil Albert Sabin, Fortaleza 60410-790, Brazil
University of Virginia, Charlottesville, Virginia 22908, United States
Additional Information
Ending date: April 2005
Last updated: October 24, 2006
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