Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants

Efficacy of Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants

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.

Study Overview

• Status: Completed
• Conditions: Development; Biological Markers; Nutrition; Short Bowel Syndrome; Bloodstream Infections
• Intervention / Treatment: Drug: Glutamine; Dietary supplement: L-alanine

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • C.S. Mott Children's Hosptial
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: Glutamine; 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months); Other Names: NutreStore
Placebo Comparator: 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).	Dietary supplement: L-alanine; 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)
No Intervention: Healthy Control; Healthy age-matched infants (n=12) will have serial stools collected on 4 occasions, each separated by 60 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Bloodstream Infections (BSI)	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.	6 months
Length Velocity	Assess the efficacy of 6 months of therapy with enteral Glutamine on length velocity.	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: April 10, 2012
• First Submitted That Met QC Criteria: April 11, 2012
• First Posted (Estimate): April 12, 2012

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 8, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Growth; Biological Markers; Parenteral Nutrition; Atresia; Short Bowel Syndrome; Necrotizing Entercolitis (NEC)
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Postoperative Complications; Disease Attributes; Disease; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Sepsis; Syndrome; Infections; Communicable Diseases; Short Bowel Syndrome
• Other Study ID Numbers: 2010-2706; 1R21DK088027-01A1 (U.S. NIH Grant/Contract)