Status:
COMPLETED
Market Research - Acceptability Trial for a New PKU Amino Acid Based Protein Substitute
Lead Sponsor:
Dr. Schär AG / SPA
Conditions:
PKU
Phenylketonurias
Eligibility:
All Genders
3-16 years
Phase:
NA
Brief Summary
The aim of this study is to demonstrate that a new protein substitute is acceptable and well tolerated in children with PKU.
Eligibility Criteria
Inclusion
- Diagnosis of PKU or PKU variant requiring a phenylalanine-free protein substitute
- Subjects who are already taking a phenylalanine-free protein substitute and are willing to try the study product for 7 days
- Patients aged 3 years of age to adulthood
- Written informed consent obtained from parental caregiver
Exclusion
- Presence of serious concurrent illness
- Investigator'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 patients having taken antibiotics over the previous 2 weeks leading up to the study.
- Patients less than 3 years of age.
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04309331
Start Date
July 1 2018
End Date
September 19 2018
Last Update
March 16 2020
Active Locations (1)
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1
Birmingham Children's Hospital
Birmingham, United Kingdom, B4 6NH