Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-24 @ 7:18 PM
NCT ID:
NCT01576003
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Weeks
Maximum Age:
12 Months
Study:
NCT01576003
Study Brief:
Protocol Section:
NCT01576003