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

Metabolic Disease Clinical Trial

Official title:

Market Research - Acceptability Trial for a New PKU Amino Acid Based Protein Substitute (Dr Schär Medical Nutrition - Mevalia Amino Acids) Mevalia PKU Motion 10 - Tropical or Red Fruits Mevalia PKU Motion 20 - Tropical or Red Fruits

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04309331
• Other study ID #: Motion1
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: September 19, 2018

Study information

• Verified date: March 2020
• Source: Dr. Schär AG / SPA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 19, 2018
• Est. primary completion date: September 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inborn Errors of Metabolism
• Metabolic Disease
• Metabolic Diseases
• Metabolism, Inborn Errors
• Phenylketonurias
• PKU

Intervention

Dietary Supplement:
• Motion
Amino acid based protein substitute

Locations

Country	Name	City	State
United Kingdom	Birmingham Children's Hospital	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Schär AG / SPA

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal tolerance	Questionnaire detailing any GI symptoms, severity and change from usual; • The collection of daily data about the gastro-intestinal tolerance of the protein substitute.	7 days
Primary	Product compliance	Daily questionnaire on amounts offered and amounts actually consumed, compared to recommended amount.	7 days
Primary	Product palatability	Questionnaire data captured to evaluate taste	7 days
Primary	Product acceptability	Brief tick-box questionnaire on overall liking and acceptability of product	7 days