CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Glutamine +1 moredrug
Likely dose
Glutamine 0.3 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01576003
NCT01576003N/ACompleted
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Efficacy of Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants

Children's Hospital Medical Center, Cincinnati·interventional·Posted Apr 12, 2012·Updated Jun 11, 2020

In Brief

A clinical study evaluating Glutamine and L-alanine for Bloodstream Infections and 4 related conditions. Completed, enrolled 10 participants across 2 sites.

Detailed Summary

The purpose of this research study is to evaluate the effects (good and bad) of supplementation with Glutamine to that of a placebo (L-alanine), on your child and their Short Bowel Syndrome. Researchers are doing this study to see if the addition of Glutamine to oral/tube feeding (nutrition therapy) will work better by preventing bloodstream infections, improving growth, and/or changing the make-up of bacteria in your child's intestine. Glutamine is approved by the FDA for use in adults with Short Bowel Syndrome. In this study, the investigators will be assessing how well Glutamine affects Short Bowel Syndrome in children.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBloodstream Infections, Short Bowel Syndrome, Development, Nutrition, Biological Markers
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Emmaus Medical, Inc., University of Michigan, Emory University, University of Colorado, Denver

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 12, 2012
Enrollment StartApr 1, 2012
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 14.2 years ago

Interventions

Glutaminedrug

0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)

L-alaninedietary

0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)