Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants (NCT01576003) | Clinical Trial Compass
CompletedNot Applicable
Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants
United States10 participantsStarted 2012-04
Plain-language 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.
Who can participate
Age range
6 Weeks – 12 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Bloodstream Infections (BSI)
Timeframe: 6 months
2
Length Velocity
Timeframe: 6 months
Trial details
NCT IDNCT01576003
SponsorChildren's Hospital Medical Center, Cincinnati