Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants

Nutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01576003
• Other study ID #: 2010-2706
• Secondary ID: 1R21DK088027-01A
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: June 2015

Study information

• Verified date: June 2020
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Biological Markers
• Bloodstream Infections
• Communicable Diseases
• Development
• Infection
• Nutrition
• Short Bowel Syndrome
• Syndrome

Intervention

Drug:
• Glutamine
0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)

Dietary Supplement:
• L-alanine
0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)

Locations

Country	Name	City	State
United States	C.S. Mott Children's Hosptial	Ann Arbor	Michigan
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (6)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Length Velocity	Assess the efficacy of 6 months of therapy with enteral Glutamine on length velocity.	6 months
Secondary	Head Circumference	Assess the efficacy of 6 months of therapy with enteral Glutamine on head circumference	6 months
Secondary	Mid Arm Circumference	Assess the efficacy of 6 months of therapy with enteral Glutamine on mid arm circumference.	6 months
Secondary	Weight Velocity	Assess the efficacy of 6 months of therapy with enteral Glutamine on weight velocity.	6 months