Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants

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.

Conditions

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

Interventions

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)

Sponsors & Collaborators

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

  collaborator NIH

• Emmaus Medical, Inc.

  collaborator INDUSTRY

• University of Michigan

  collaborator OTHER

• Emory University

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  lead OTHER

Principal Investigators

• Conrad R Cole, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

6 Weeks

Max Age

12 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-04-30

Primary Completion

2015-06-30

Completion

2015-06-30

Countries

• United States

Study Locations