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 @ 3:36 PM
Ignite Modification Date:
2025-12-24 @ 3:36 PM
NCT ID:
NCT06298292
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Tyrosinaemia type I, II III or Alkaptonuria requiring a tyrosine- and phenylalanine-free protein substitute.
* Diagnosis of Homocystinuria requiring a methionine-free, cystine-enriched protein substitute.
* Diagnosis of MSUD requiring a valine-, leucine- and isoleucine-free protein substitute.
* Subjects who are already taking a protein substitute for one of the specified rare metabolic disorders and are willing to try the study product for 7 days.
* Children aged 7 years and over.
* Written informed consent obtained from parental caregiver.
Exclusion Criteria:
* Presence of serious concurrent illness
* Lead Dietitian's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
* 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.
* Children less than 7 years of age.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
18 Years
Study:
NCT06298292
Study Brief:
Protocol Section:
NCT06298292