Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants
Bloodstream Infections, Short Bowel Syndrome, Development
About this trial
This is an interventional treatment trial for Bloodstream Infections focused on measuring Short Bowel Syndrome, Necrotizing Entercolitis (NEC), Atresia, Parenteral Nutrition, Biological Markers, Growth
Eligibility 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
Sites / Locations
- C.S. Mott Children's Hosptial
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
No Intervention
Glutamine
L-alanine
Healthy Control
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).
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).
Healthy age-matched infants (n=12) will have serial stools collected on 4 occasions, each separated by 60 days.