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 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT05269992
Eligibility Criteria:
Inclusion Criteria:
* Children from 1 year to 16 years of age.
* Requiring oral or enteral nutritional support from a whole protein 1kcal/ml or a 1.5kcal/ml enteral tube feed (via an existing enteral feeding tube) or oral nutritional supplement for at least 28 days.
* Expected to receive a minimum of 300kcal/day from the study product(s).
* Informed consent obtained from the patient/carer.
Exclusion Criteria:
* Total parenteral nutrition (100% of requirements).
* Allergy to any of the study product ingredients.
* Severe galactose (galactosaemia) or lactose intolerance.
* Severe hepatic, metabolic or renal dysfunction.
* Requirement for a fibre free feed.
* Requirement for a hydrolysed, elemental or any other specialised feed.
* On high intensity chemotherapy or radiation therapy, pancreatitis, chylothorax, or Inflammatory Bowel Disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
16 Years
Study:
NCT05269992
Study Brief:
Protocol Section:
NCT05269992