NCT05418491

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 455 (actual)
• Sponsor: FrieslandCampina · Industry
• Sex: All
• Age: 5 Years – 63 Months
• Healthy volunteers: Not accepted

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 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.

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.

Conditions

• Allergy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-07-21
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2022-06-14
• Last updated: 2025-03-13

Locations

3 sites across 3 countries: Bulgaria, Cyprus, Greece