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 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT03913156
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of PKU identified on screening during the newborn period and requiring a phenylalanine free protein substitute
* Subjects who are about to commence weaning and require a concentrated phe-free protein substitute to meet their total protein requirements and are aged between 4 and 10 months (Part 1)
* Subjects aged under 5 years who have already been fully transferred onto a concentrated phe-free protein substitute and are willing to try the study product for 7 days (Part 2)
* Written informed consent obtained from subject or parents / caregiver
* May or may not have commenced weaning solids (i.e. using normal foods)
Exclusion Criteria:
* Presence of serious concurrent illness
* Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
* Any child who has not commenced a second stage protein substitute and is over the age of 10 months
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
* Any children having taken antibiotics over the previous 2 weeks leading up to the study
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
5 Years
Study:
NCT03913156
Study Brief:
Protocol Section:
NCT03913156