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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04309331
Other study ID # Motion1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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