N/A
N=9
Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants
Bloodstream Infections · Short Bowel Syndrome · Development · Nutrition · Biological Markers
Bottom Line
View on ClinicalTrials.gov: NCT01576003 ↗Enrolled (actual)
9
Serious AEs
33.3%
Results posted
Jun 2020
Primary outcome: Primary: Number of Participants With Bloodstream Infections (BSI) — 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Glutamine (Drug); L-alanine (Dietary_supplement)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Bloodstream Infections (BSI) |
0; 1 | — |
| PRIMARY Length Velocity |
60.9; 66.0; 62.2; 67.5; 66.8; 73.7 | — |
| SECONDARY Head Circumference |
42.9; 43.8; 43.5; 43.4; 48.8; 46 | — |
| SECONDARY Mid Arm Circumference |
13; 16.0; 12.6; 16.0; 12.5; 8.8 | — |
| SECONDARY Weight Velocity |
6.5; 8.1; 6.4; 8.4; 7.1; 9.3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01576003). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.