Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants



Status:Completed
Conditions:Food Studies, Infectious Disease, Gastrointestinal
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases, Pharmacology / Toxicology
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:April 2012
End Date:June 2015

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Efficacy of Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants

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.

This is a double-blind, randomized placebo-controlled pilot study to investigate the
efficacy of enteral glutamine (GLN) supplementation in 36 infants, ≤ 12 months of age with
parenteral nutrition (PN)-dependent short bowel syndrome (SBS) due to massive small bowel
resection for NEC and/or atresia on improving weaning of PN and preventing infections. The
investigators intend to evaluate the effect of enteral feeding and GLN supplementation on
the gut bacteria. The investigators will also recruit 12 age-matched controls to evaluate
the normal gut bacteria.

Inclusion Criteria for Controls:

- Less than or equal to 12 months of age

- Normal small bowel length without any intestinal resection or primary intestinal
disease

- Not currently on TPN and if ever on TPN this should have been discontinued for at
least 4 weeks.

Exclusion Criteria for Controls:

- Major congenital or chromosomal anomalies

- Inability to tolerate enteral nutrition/regular cow's milk, breast milk or formula

- History of liver/intestinal transplantation

Inclusion Criteria for Glutamine and Placebo Group of SBS Patients:

- Less than or equal to 12 months of age

- Patients who have undergone small bowel resection due to NEC or intestinal atresia
with known small bowel length

- Patients who have been PN dependent for more than 42 consecutive days and currently
on TPN at time of enrollment

- Patients who have the ability to take partial enteral nutrition or breast milk or
elemental formula to allow the appropriate dose of glutamine or placebo

- Signed informed consent for the use of Glutamine or placebo

Exclusion Criteria for Glutamine and Placebo Group of SBS Patients:

- Major congenital or chromosomal anomalies

- Inability to tolerate enteral nutrition that will preclude treatment with enteral
Glutamine or L-alanine placebo for > 2 weeks

- Liver/Intestinal transplantation
We found this trial at
2
sites
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Ann Arbor, Michigan 48109
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