WithdrawnPhase 3

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

108 participantsStarted 2004-08

Plain-language 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.

Who can participate

Age range3 Months – 3 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Be an inpatient and willing to stay for 7 nights at HIAS.
✓. Child´s parent or guardian must sign informed consent..

Exclusion criteria

✕. Children exclusively breast-fed (Reason: The diet needs to be controlled in order to evaluate the study treatment effect)
✕. 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.)
✕. Children with suspected other illnesses as indicated by fever \>102º F at time of screening off antipyretics
✕. Children with suspected systemic disease at the time of screening including but not limited to shock, meningitis, sepsis, pneumonia, tuberculosis, varicella
✕. 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.

Trial details

NCT IDNCT00133562

SponsorUniversity of Virginia

Sponsor typeOTHER

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Diarrhea, Malnutrition trials