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Evaluation of PKU Explore France

NCT04898829 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-11-28

No results posted yet for this study

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.

Conditions

  • Phenylketonurias

Interventions

DIETARY_SUPPLEMENT

PKU explore

For 28 consecutive days, participants will 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.

Sponsors & Collaborators

  • Vitaflo International, Ltd

    lead INDUSTRY

Principal Investigators

  • Karine Mention · CHU Lille

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-18
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04898829 on ClinicalTrials.gov