An Exploratory Study to Evaluate the Acceptability of PKU Explore, a Food for Special Medical Purposes, for Use in the Dietary Management of Phenylketonuria in Infants From 6 Months to 3 Years of Age With Regard to Product-acceptability, Tolerance, Phe Levels and Growth

  • STATUS
    Recruiting
  • End date
    May 31, 2025
  • participants needed
    10
  • sponsor
    Vitaflo International, Ltd
Updated on 14 October 2022
total protein
amino acid protein

Summary

PKU explore France is an exploratory study to evaluate the acceptability of PKU explore, a food for special medical purposes, for use in the dietary management of phenylketonuria in infants from 6 months to 3 years of age, assessing participant adherence, GI tolerance, phe levels, growth and product palatability.

Description

The study product, PKU explore, is a concentrated, spoonable, protein substitute food for special medical purposes, used in the dietary management of PKU. The recommended amount will be determined by a dietitian or clinician and the product used is unflavoured.

PKU explore France is an exploratory study to evaluate the gastrointestinal tolerance, palatability, and participant adherence over a four-week period in patients with PKU that follow an appropriate restricted therapeutic diet. This will be followed by a maximum 24-month follow-up period monitoring growth as per routine standard of care.

Up to 10 participants will be recruited at a single centre in France.

For 28 consecutive days, up to 10 participants, aged 6 months to 3 years inclusive, take their usual restricted therapeutic diet, either replacing their usual second-stage, concentrated protein substitute with PKU explore or commencing PKU explore and gradually reducing their Phe-free formula for infants.

Their parent/guardian complete a daily questionnaire on adherence and tolerance, and a final questionnaire on usage and acceptability.

Details
Condition Phenylketonurias
Treatment PKU Explore
Clinical Study IdentifierNCT04898829
SponsorVitaflo International, Ltd
Last Modified on14 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

A diagnosis of PKU on new-born screening requiring a low protein diet and Phe-free L-amino acid protein substitute
Aged between 6 months and 3 years (inclusive at screening)
Already taking part of their protein substitute in a spoonable form OR is at the stage in their PKU management when a second stage spoonable protein substitute is recommended to commence
Well-controlled PKU, evidenced by the latest three routine blood spots being within the acceptable range, in the investigator's opinion
Able to comply with the study protocol and take the study product, according to the opinion of the investigator
Willingly given, written, informed consent from parents/guardian

Exclusion Criteria

Diagnosis of persistent hyperphenylalaninaemia, or mild PKU not requiring dietary intervention with a low protein diet and Phe-free L-amino acid supplements
Diagnosis of a concurrent condition which may adversely affect developmental progression and feeding ability
Known milk or fish allergy/intolerance
Patients who are currently participating in, plan to participate in or have participated in an interventional investigational drug, food or medical device trial within 30 days prior to the screening visit
Existing significant GI issues which may affect compliance with the study protocol, according to the opinion of the investigator
Any medical conditions precluding the study intervention, which in the opinion of the investigator may impact on metabolic control during the study period
Use of additional macro/micronutrient supplements during the study period, unless clinically indicated and prescribed by the investigator (must be recorded in patient case record file)
Where applicable, patients NOT covered by Health Insurance System and/or not in compliance with the recommendations of National Law in force
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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