Trials / Completed
CompletedNCT01576003
Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants
Efficacy of Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Children's Hospital Medical Center, Cincinnati · Academic / Other
- Sex
- All
- Age
- 6 Weeks – 12 Months
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2012-04-01
- Primary completion
- 2015-06-01
- Completion
- 2015-06-01
- First posted
- 2012-04-12
- Last updated
- 2020-06-11
- Results posted
- 2020-06-11
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01576003. Inclusion in this directory is not an endorsement.