Status:
COMPLETED
The Prolonged Effect of Consumption of a Partially Hydrolyzed Infant Formula During the First 6 Months of Life on the Development of Allergic Manifestations At 5 Years of Age
Lead Sponsor:
FrieslandCampina
Conditions:
Allergy
Eligibility:
All Genders
5-63 years
Brief Summary
The present study is a 5-year follow-up of the Allergy Reduction Trial (A.R.T.) birth cohort study of 551 infants at high-risk for allergy. The A.R.T. 5-year follow-up study, aims to investigate the p...
Detailed Description
The present study is a 5-year follow-up of the Allergy Reduction Trial (A.R.T.) birth cohort study of 551 infants at high-risk for allergy. The A.R.T. 5-year follow-up study, aims to investigate the p...
Eligibility Criteria
Inclusion
- Children who were part of the Intention-to-Treat population of the A.R.T. study
- Children of the A.R.T. study ITT population within the age range of 5 years up to 5 years and 3 months
- Children of the A.R.T. study ITT population in whom at least one parent and/or legal guardian signed the written consent form
Exclusion
- Children who did not participate in the A.R.T. study or who were not assigned to any of the 3 study arms
- Children of the A.R.T. study who are younger than 5 years of age or older than 5 years and 3 months of age
- Children of the A.R.T. study in whom parents and/or guardians do not agree to provide a written consent form
Key Trial Info
Start Date :
July 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
455 Patients enrolled
Trial Details
Trial ID
NCT05418491
Start Date
July 21 2022
End Date
July 31 2024
Last Update
March 13 2025
Active Locations (3)
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1
Medical University of Varna
Varna, Bulgaria, 9002
2
Asthma and Allergy Centre LTD
Limassol, Cyprus, 24 Nafpliou Street, 3025
3
Harokopio University
Athens, Greece, Thiseos 70, Kallithea 176 71