WithdrawnPhase 3

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

108 participantsStarted 2004-08

Plain-language 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.

Who can participate

Age range3 Months – 36 Months

SexALL

See this in plain English?

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 -1, which is the median of HAZ scores 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 \>102 degrees 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.

Trial details

NCT IDNCT00338221

SponsorUniversity of Virginia

Sponsor typeOTHER

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Diarrhea, Malnutrition trials