Clinical trial NCT01576003: Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants
Official title: Efficacy of Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bloodstream Infections
Short Bowel Syndrome
Development
Nutrition
Biological Markers
Keywords: Short Bowel Syndrome
Necrotizing Entercolitis (NEC)
Atresia
Parenteral Nutrition
Biological Markers
Growth
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Emmaus Medical, Inc.
name: University of Michigan
name: Emory University
name: University of Colorado, Denver
First posted: 2012-04-12
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Bloodstream Infections (BSI)
timeFrame: 6 months
measure: Length Velocity
timeFrame: 6 months
Secondary outcomes:
measure: Head Circumference
timeFrame: 6 months
measure: Mid Arm Circumference
timeFrame: 6 months
measure: Weight Velocity
timeFrame: 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: C.S. Mott Children's Hosptial
state: Michigan
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Conrad R Cole, MD
role: PRINCIPAL_INVESTIGATOR
References: