Status:
COMPLETED
Acceptability and Tolerance of a Ready-to-use Protein Substitute in Tablet Form for the Dietary Management of Phenylketonuria
Lead Sponsor:
metaX Institut fuer Diatetik GmbH
Collaborating Sponsors:
Birmingham Children's Hospital
Conditions:
Phenylketonurias
Hyperphenylalaninaemia
Eligibility:
All Genders
7-18 years
Brief Summary
The purpose of this prospective, observational study is to evaluate the tolerability and acceptability of phenylalanine-free protein substitute tablets for young children with PKU aged of 7 years or o...
Detailed Description
The principle treatment for children with phenylketonuria (PKU) is a low protein diet. Part of this treatment requires the administration of a phenylalanine-free protein substitute in order to meet ba...
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.
- Children aged 7 years and over.
- Written informed consent obtained from parental caregiver.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 10 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04375592
Start Date
February 1 2021
End Date
May 10 2021
Last Update
March 4 2024
Active Locations (1)
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1
Birmingham Children´s Hospital
Birmingham, Wales, United Kingdom, B4 6NH