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

A Post-intervention Follow-up of the Allergy Reduction Trial, to Investigate the Prolonged Risk Reducing Effect of a Partially Hydrolysed Infant Formula During the First Six Months of Life on Allergic Manifestations Up to the Age of 5 Years

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 prolonged effect of each feeding regimen [formula-fed (exclusively or partially) with the partially hydrolyzed formula (pHF) or the standard formula (SF), or exclusively breastfed] within the first 6 months of life on the development of any allergic manifestations up to the age of 5 years. Allergic manifestations within this time period will include the presence of any of the following: atopic dermatitis, food allergies, respiratory allergies, urticaria, drug allergy and insect venom allergy. In addition, differences on growth (weight, height, BMI) will be examined.

Study Overview

• Status: Completed
• Conditions: Allergy
• Intervention / Treatment: Other: No intervention is used in the current study. Interventions were given in the original A.R.T. study

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 prolonged effect of each feeding regimen [formula-fed (exclusively or partially) with the partially hydrolyzed formula (pHF) or the standard formula (SF), or exclusively breastfed] within the first 6 months of life on the development of any allergic manifestations up to the age of 5 years. Allergic manifestations within this time period will include the presence of any of the following: atopic dermatitis, food allergies, respiratory allergies, urticaria, drug allergy and insect venom allergy. In addition, differences on growth (weight, height, BMI) will be examined.

• Study Type: Observational
• Enrollment (Actual): 455

Contacts and Locations

Study Locations

• Bulgaria
  • Varna, Bulgaria, 9002
    • Medical University of Varna
• Cyprus
  • Limassol, Cyprus, 24 Nafpliou Street, 3025
    • Asthma and Allergy Centre LTD
• Greece
  • Athens, Greece, Thiseos 70, Kallithea 176 71
    • Harokopio University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 5 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The target population of the present study are all the A.R.T. subjects who consisted the Intention-to-Treat (ITT) population (N=551).

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Partially hydrolyzed protein Infant formula; Originating from A.R.T. cohort.	Other: No intervention is used in the current study. Interventions were given in the original A.R.T. study; The current study is a post-intervention study; interventions were given in the original A.R.T. study
Standard infant formula; Originating from A.R.T. cohort.	Other: No intervention is used in the current study. Interventions were given in the original A.R.T. study; The current study is a post-intervention study; interventions were given in the original A.R.T. study
Exclusively breastfed infants; Originating from A.R.T. cohort.	Other: No intervention is used in the current study. Interventions were given in the original A.R.T. study; The current study is a post-intervention study; interventions were given in the original A.R.T. study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of allergic Manifestations	Incidence of allergic manifestations (AM) based on parental reporting using Childhood Allergy questionnaire comparing partially hydrolyzed protein formula, standard formula and exclusive breastfeeding.	At 5 years of age

Collaborators and Investigators

• Sponsor: FrieslandCampina
• Investigators: Principal Investigator: Yannis Manios, Dr., Harokopio University

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2022
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: post-intervention, allergic manifestations
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: A.R.T. Follow-Up

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No