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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT01448135
Eligibility Criteria:
Inclusion Criteria:
* Subject requires enteral tube feeding as sole source of nourishment
* Subject, or subject's legally acceptable representative (LAR), has provided voluntarily and informed consent form, as deemed appropriate and approved by the Columbia University Medical Center Institutional Review Board
* Subject is ≥ 18 years of age
* Subject is male or non-pregnant female at least six weeks postpartum and non-lactating females of childbearing potential will be required to confirm non-pregnancy status with a pregnancy test at screening
* Subject has an initial APACHE II score less than or equal to 24
Exclusion Criteria:
* Subject requires parenteral nutrition
* Subject is acutely impacted or constipated
* Subject has intestinal obstruction
* Subject is too hemodynamically unstable for enteral feeding
* Subject has an allergy or intolerance to any ingredient in the study product by documentation or verbal report by subject or subject's LAR
* Subject is participating in a non-Abbott approved concomitant trial
* Subject has gastrointestinal disease, including acute pancreatitis, active gastrointestinal bleeding, acute inflammatory bowel disease, or has undergone intestinal surgery within the past month
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01448135
Study Brief:
Protocol Section:
NCT01448135