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

Last updated: October 27, 2008
Sponsor: University of Virginia
Overall Status: Trial Not Available

Phase

3

Condition

Colic

Diet And Nutrition

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT00338221
02-039
  • Ages 3-36
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Children ages 3 to 36 months with a history of persistent diarrhea (3 or more unformedstools/day) for > 2 weeks or height-for-age Z-score (HAZ) less than -1, which is themedian 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

Exclusion Criteria:

  1. Children exclusively breast-fed (Reason: The diet needs to be controlled in order toevaluate the study treatment effect)

  2. Children who participated in the "community study" or any other study within the pasttwo years (Reason: The children in the "community study" will have receivedglutamine.)

  3. Children with suspected other illnesses as indicated by fever >102 degrees F at timeof screening off antipyretics.

  4. Children with suspected systemic disease at the time of screening including but notlimited to shock, meningitis, sepsis, pneumonia, tuberculosis, varicella

  5. Severe malnutrition defined as HAZ <-3.

Study Design

Total Participants: 108
Study Start date:
August 01, 2004
Estimated Completion Date:
April 30, 2005

Study 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.