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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07303868
Eligibility Criteria:
Pediatric patients ages 5 to 21 in the randomized arm Inclusion criteria
* receive at least 80% of their nutritional needs via gastrostomy
* receive blenderized feeds or will start receiving blenderized feeds
* have no known allergies to ingredients in blenderized feeds;
* receive their bolus feeds within 30 minutes or less
* can receive their feeds by syringe push Exclusion criteria
* have undergone anti-reflux surgery
* receive post-pyloric feeds
* are allergic to any component of the administered diets
* cannot receive their gastrostomy feeds over 30 minutes
* require a feeding pump for feed administration (as the H-BBB is too thick for pump administration).
Pediatric patients ages 5 to 21 in the observational arm Inclusion
* receive at least 80% of their nutritional needs via gastrostomy
* are taking an amino acid formula
* have not undergone antireflux surgery Exclusion
* have undergone anti-reflux surgery
* receive post-pyloric feeds
* are not receiving an amino acid-based formula.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
21 Years
Study:
NCT07303868
Study Brief:
Protocol Section:
NCT07303868