Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants

NCT ID: NCT01576003

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2015-06-30

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.

Conditions

Bloodstream Infections; Short Bowel Syndrome; Development; Nutrition; Biological Markers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Glutamine

Intervention Type: DRUG

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

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).

Group Type: PLACEBO_COMPARATOR

L-alanine

Intervention Type: DIETARY_SUPPLEMENT

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

Healthy Control

Healthy age-matched infants (n=12) will have serial stools collected on 4 occasions, each separated by 60 days.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Glutamine

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

Intervention Type: DRUG

L-alanine

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

NutreStore

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• Major congenital or chromosomal anomalies
• Inability to tolerate enteral nutrition/regular cow's milk, breast milk or formula
• History of liver/intestinal transplantation

• 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

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Emmaus Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Conrad R Cole, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

C.S. Mott Children's Hosptial

Ann Arbor, Michigan, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R21DK088027-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2010-2706

Identifier Type: -

Identifier Source: org_study_id