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Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants

Primary Purpose

Bloodstream Infections, Short Bowel Syndrome, Development

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Glutamine
L-alanine
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

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

6 Weeks - 12 Months (Child)All SexesAccepts Healthy Volunteers

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

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Glutamine

L-alanine

Healthy Control

Arm 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).

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.

Outcomes

Primary Outcome Measures

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.
Length Velocity
Assess the efficacy of 6 months of therapy with enteral Glutamine on length velocity.

Secondary Outcome Measures

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

Full Information

First Posted
April 10, 2012
Last Updated
June 8, 2020
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Emmaus Medical, Inc., University of Michigan, Emory University, University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT01576003
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Emmaus Medical, Inc., University of Michigan, Emory University, University of Colorado, Denver

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bloodstream Infections, Short Bowel Syndrome, Development, Nutrition, Biological Markers
Keywords
Short Bowel Syndrome, Necrotizing Entercolitis (NEC), Atresia, Parenteral Nutrition, Biological Markers, Growth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glutamine
Arm Type
Experimental
Arm 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).
Arm Title
L-alanine
Arm Type
Placebo Comparator
Arm 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).
Arm Title
Healthy Control
Arm Type
No Intervention
Arm Description
Healthy age-matched infants (n=12) will have serial stools collected on 4 occasions, each separated by 60 days.
Intervention Type
Drug
Intervention Name(s)
Glutamine
Other Intervention Name(s)
NutreStore
Intervention Description
0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)
Intervention Type
Dietary Supplement
Intervention Name(s)
L-alanine
Intervention Description
0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)
Primary Outcome Measure Information:
Title
Number of Participants With Bloodstream Infections (BSI)
Description
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.
Time Frame
6 months
Title
Length Velocity
Description
Assess the efficacy of 6 months of therapy with enteral Glutamine on length velocity.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Head Circumference
Description
Assess the efficacy of 6 months of therapy with enteral Glutamine on head circumference
Time Frame
6 months
Title
Mid Arm Circumference
Description
Assess the efficacy of 6 months of therapy with enteral Glutamine on mid arm circumference.
Time Frame
6 months
Title
Weight Velocity
Description
Assess the efficacy of 6 months of therapy with enteral Glutamine on weight velocity.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Conrad R Cole, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
C.S. Mott Children's Hosptial
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

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Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants

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