Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Emmaus Medical, Inc.; Emory University; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of Colorado, Denver; University of Michigan

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