Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Bloodstream Infections; Short Bowel Syndrome; Nutrition; Biological Markers; Development

Treatments: Drug: Glutamine; Dietary Supplement: L-alanine

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT01576003

2010-2706

1R21DK088027-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 6 weeks to 12 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 Total Parenteral Nutrition (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 Short Bowel Syndrome (SBS) Patients:

• Less than or equal to 12 months of age
• Patients who have undergone small bowel resection due to necrotizing enterocolitis (NEC) or intestinal atresia with known small bowel length
• Patients who have been Parenteral Nutrition (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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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10 participants in 3 patient groups, including a placebo group

Glutamine

Experimental group

Description:

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).

Treatment:

Drug: Glutamine

L-alanine

Placebo Comparator group

Description:

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).

Treatment:

Dietary Supplement: L-alanine

Healthy Control

No Intervention group

Description:

Healthy age-matched infants (n=12) will have serial stools collected on 4 occasions, each separated by 60 days.