Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bloodstream Infections, Short Bowel Syndrome, Development, Nutrition, Biological Markers

Intervention / Treatment
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* Drug: Glutamine
* Dietary Supplement: L-alanine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glutamine<br>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). | Drug: Glutamine<br>* 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)<br>* Other names: NutreStore;|
| Placebo Comparator: L-alanine<br>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). | Dietary Supplement: L-alanine<br>* 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)<br>|
| No Intervention: Healthy Control<br>Healthy age-matched infants (n=12) will have serial stools collected on 4 occasions, each separated by 60 days. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Length Velocity | Assess the efficacy of 6 months of therapy with enteral Glutamine on length velocity. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Head Circumference | Assess the efficacy of 6 months of therapy with enteral Glutamine on head circumference | 6 months | 
| Mid Arm Circumference | Assess the efficacy of 6 months of therapy with enteral Glutamine on mid arm circumference. | 6 months | 
| Weight Velocity | Assess the efficacy of 6 months of therapy with enteral Glutamine on weight velocity. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Short Bowel Syndrome, Necrotizing Entercolitis (NEC), Atresia, Parenteral Nutrition, Biological Markers, Growth