Feeding Patterns and Practices in Young Children With PKU During the First Two Years of Life (PKU-weaning)

Nutricia

Status: Completed

Conditions: PKU

Treatments: Other: B2970 Metabolic Texture Modified Protein Substitute

Study type: Interventional

Funder types: Industry

Identifiers

NCT03913156

B2970

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 46 patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of PKU identified on screening during the newborn period and requiring a phenylalanine free protein substitute
• Subjects who are about to commence weaning and require a concentrated phe-free protein substitute to meet their total protein requirements and are aged between 4 and 10 months (Part 1)
• Subjects aged under 5 years who have already been fully transferred onto a concentrated phe-free protein substitute and are willing to try the study product for 7 days (Part 2)
• Written informed consent obtained from subject or parents / caregiver
• May or may not have commenced weaning solids (i.e. using normal foods)

Exclusion criteria

• Presence of serious concurrent illness
• Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
• Any child who has not commenced a second stage protein substitute and is over the age of 10 months
• Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
• Any children having taken antibiotics over the previous 2 weeks leading up to the study

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Part 1

Other group

Description:

Part 1 of the study will recruit subjects who are about to be introduced to a concentrated phe-free protein substitute (i.e. second stage protein substitute) for the first time.

Treatment:

Other: B2970 Metabolic Texture Modified Protein Substitute

Part 2

Other group

Description:

Part 2 of the study will recruit subjects who have already been introduced to a concentrated phe-free protein substitute (i.e. have already transferred from phe-free infant formula onto a second stage protein substitute). This group will be included to evaluate the acceptability of the study product in patients who have already moved onto a second stage protein substitute.

Treatment:

Other: B2970 Metabolic Texture Modified Protein Substitute