NCT00338221

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2004

Shorter than P25 for phase_3

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
Last Updated

October 28, 2008

Status Verified

October 1, 2008

First QC Date

June 15, 2006

Last Update Submit

October 27, 2008

Conditions

Diarrhea, Malnutrition

Keywords

Diarrhea, Malnutrition, Brazil

Interventions

alanyl-glutamineDRUG
glycineDRUG

Eligibility Criteria

Age3 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DiarrheaMalnutrition

Interventions

alanylglutamineGlycine

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Richard L Guerrrant, MD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2006

First Posted

June 20, 2006

Study Start

August 1, 2004

Study Completion

April 1, 2005

Last Updated

October 28, 2008

Record last verified: 2008-10