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NCT Number: NCT01576003

Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants

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.

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Key information

Conditions

Bloodstream Infections Biological Markers Development Digestive System Diseases Gastrointestinal Diseases Hyperphagia Infections Inflammation Intestinal Diseases Malabsorption Syndromes Nutrition Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Sepsis Short Bowel Syndrome Signs and Symptoms Signs and Symptoms, Digestive Systemic Inflammatory Response Syndrome

Age range

6 week–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

C.S. Mott Children's Hosptial, Ann Arbor, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glutamine

Drug

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

Other names: NutreStore

L-alanine

Dietary Supplement

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

Primary outcomes

  1. Number of Participants With Bloodstream Infections (BSI)

    Time frame: 6 months

    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.

  2. Length Velocity

    Time frame: 6 months

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

Secondary outcomes

  1. Head Circumference

    Time frame: 6 months

    Assess the efficacy of 6 months of therapy with enteral Glutamine on head circumference

  2. Mid Arm Circumference

    Time frame: 6 months

    Assess the efficacy of 6 months of therapy with enteral Glutamine on mid arm circumference.

  3. Weight Velocity

    Time frame: 6 months

    Assess the efficacy of 6 months of therapy with enteral Glutamine on weight velocity.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Emmaus Medical, Inc.
  • Emory University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Colorado, Denver
  • University of Michigan

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 12, 2012
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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