PKU Clinical Trial
Official title:
Feeding Patterns and Practices in Young Children With PKU During the First Two Years of Life: Acceptability and Efficacy of a New Protein Substitute
In this study the feeding patterns and practices at the introduction of a second stage phe-free protein substitute will be assessed in young children with PKU. This will be compared with the normal weaning process in healthy non-PKU age-matched children. In addition, tolerability and acceptability of the study product will be evaluated in a smaller group of subjects who have already been transferred onto a second stage protein substitute. The study is performed in 3 centers in the United Kingdom.
Part 1:
For subjects with PKU, the study product will be incorporated in the diet as the second stage
protein substitute until the subjects are 2 years of age.
The healthy non-PKU age-matched subjects will not have the study product incorporated in
their diet in order to be able to compare the weaning experience and nutritional intake of
PKU subjects with non-PKU subjects. The healthy subjects will also be part of the study until
the subjects are 2 years of age.
Part 2:
All PKU subjects will take the study product for 7 days.
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