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

Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05418491
• Other study ID #: A.R.T. Follow-Up
• Status: Enrolling by invitation
• Start date: July 21, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: February 2024
• Source: FrieslandCampina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 551
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 63 Months

Eligibility

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

Related Conditions & MeSH terms

• Allergy
• Hypersensitivity

Intervention

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

Locations

Country	Name	City	State
Bulgaria	Medical University of Varna	Varna
Cyprus	Asthma and Allergy Centre LTD	Limassol
Greece	Harokopio University	Athens

Sponsors (1)

Lead Sponsor	Collaborator
FrieslandCampina

Countries where clinical trial is conducted

Bulgaria,  Cyprus,  Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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