Overview

HIAS II - Study of Nutritional Supplementation in Hospitalized Children With Persistent Diarrhea or Malnutrition

Status:
Withdrawn
Trial end date:
2006-05-01
Target enrollment:
0
Participant gender:
All
Summary
This study will determine the effect of 7 days supplementation of alanyl-glutatime or glycine on the damaged intestinal barrier function on day 8 in children with persistent diarrhea 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 negative 1, which
is the median of HAZ score 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 >102º 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 or WAZ <-3.5 or any child weighing <10 lbs.
(4.5 kg) or any child with a weight-to-height ratio <60% of the NCHS age adjusted
norm.