Market Research - Acceptability Trial for a New PKU Amino Acid Based Protein Substitute

Dr. Schär

Status: Completed

Conditions: Phenylketonurias; Inborn Errors of Metabolism; Metabolic Disease; PKU

Treatments: Dietary Supplement: Motion

Study type: Interventional

Funder types: Industry

Identifiers

NCT04309331

Motion1

Details and patient eligibility

About

The aim of this study is to demonstrate that a new protein substitute is acceptable and well tolerated in children with PKU.

Enrollment: 12 patients

Sex: All

Ages: 3 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

PKU Motion

Experimental group

Description:

amino acid based protein substitute

Treatment:

Dietary Supplement: Motion