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Not Yet Recruiting
NCT07802366
Market Research of a Slow Release Protein Substitute for the Dietary Management of PKU
Conditions: Phenylketonuria (PKU) and Hyperphenylalaninemia, Brain Diseases, Metabolic, Inborn, Brain Disorder, Metabolic, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Amino Acid Metabolism, Inborn Errors, Metabolism, Inborn Errors, Genetic Disease, Inborn, Genetic Diseases, Inborn, Metabolic Diseases, Nutritional and Metabolic Diseases
Sex: All
Ages: 3 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 10
Sponsor: metaX Institut fuer Diatetik GmbH
Location: Birmingham Children´s Hospital Birmingham England
Summary
XPhePiccosMR is a prospective, single-arm, open label, observational study that aims to evaluate the acceptability and tolerability of XPhe Piccos, a slow-release, phenylalanine-free protein substitute in the form of tiny tablets, for use in the dietary management of phenylketonuria (PKU) in children aged three years and older.
Eligibility Criteria
Inclusion Criteria:
* Diagnosis of PKU or HPA 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.
* Subjects aged 3 years and above.
* Written informed assent/consent obtained from subject and/or parental caregiver, depending on subject age.
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 subject having taken antibiotics over the previous 2 weeks leading up to the study.
* Subjects less than 3 years of age
Source: ClinicalTrials.gov (NCT07802366). StuddyBuddy aggregates publicly available trial information.
