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

• Status: Withdrawn
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Glycine

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.