Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Collaborators:
Emmaus Medical, Inc.
University of Michigan
Emory University
University of Colorado, Denver
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01576003
First received: April 10, 2012
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Bloodstream Infections
Short Bowel Syndrome
Development
Nutrition
Biological Markers
Drug: Glutamine
Dietary Supplement: L-alanine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Incidence of bloodstream infections [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the efficacy of therapy with enteral GLN on length and weight velocity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Assess the gut lumenal microbiome [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: April 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glutamine Drug: Glutamine
0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)
Other Name: NutreStore
Placebo Comparator: L-alanine 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

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

Ages Eligible for Study:   6 Weeks to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 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 SBS Patients:

  • Less than or equal to 12 months of age
  • Patients who have undergone small bowel resection due to NEC or intestinal atresia with known small bowel length
  • Patients who have been 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576003

Contacts
Contact: Crystal Slaughter, BA 513-636-0137 crystal.slaughter@cchmc.org

Locations
United States, Michigan
C.S. Mott Children's Hosptial Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Ann Mehringer    734-232-8005    amehring@med.umich.edu   
Principal Investigator: Daniel H Teitelbaum, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Crystal Slaughter, BA    513-636-0137    crystal.slaughter@cchmc.org   
Contact: Misty Troutt    513-803-1531    misty.troutt@cchmc.org   
Principal Investigator: Conrad R. Cole, MD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Emmaus Medical, Inc.
University of Michigan
Emory University
University of Colorado, Denver
Investigators
Principal Investigator: Conrad R Cole, MD Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01576003     History of Changes
Other Study ID Numbers: 2010-2706
Study First Received: April 10, 2012
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Short Bowel Syndrome
Necrotizing Entercolitis (NEC)
Atresia
Parenteral Nutrition
Biological Markers
Growth

Additional relevant MeSH terms:
Short Bowel Syndrome
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014