Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants

Not Applicable

Completed

Conditions: Nutrition
Bloodstream Infections
Short Bowel Syndrome
Development
Biological Markers

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Glutamine	Glutamine	Infants randomized to the Glutamine group will receive L-Glutamine (GLN) administered enterally at a dose of 0.6g/kg body weight/day (0.3g/kg/dose) in 2 divided daily doses for 6 months. GLN will be dissolved in water, breast milk or formula and administered to the subject orally or through their enterostomy tube approximately every 12 hours (twice a day).
L-alanine	L-alanine	Infants randomized to the placebo group will receive L-alanine (ALA) administered enterally at a dose of 0.6g/kg body weight/day in 2 divided doses (0.3g/kg/day twice a day) for 6 months. ALA will be dissolved in water, breast milk or formula and administered to the subject orally or through their enterostomy tube approximately every 12 hours (twice a day).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Bloodstream Infections (BSI)	6 months	Evaluate the efficacy of enteral Glutamine supplementation to decrease bloodstream infections in participants that are parenteral nutrition dependent with Short Bowel Syndrome due to necrotizing enterocolitis (NEC) and/or atresia.
Length Velocity	6 months	Assess the efficacy of 6 months of therapy with enteral Glutamine on length velocity.

Secondary Outcome Measures

Name	Time	Method
Head Circumference	6 months	Assess the efficacy of 6 months of therapy with enteral Glutamine on head circumference
Mid Arm Circumference	6 months	Assess the efficacy of 6 months of therapy with enteral Glutamine on mid arm circumference.
Weight Velocity	6 months	Assess the efficacy of 6 months of therapy with enteral Glutamine on weight velocity.

Locations (2): C.S. Mott Children's Hosptial
🇺🇸
Ann Arbor, Michigan, United States
Cincinnati Children's Hospital Medical Center
🇺🇸
Cincinnati, Ohio, United States