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

Sponsor

FrieslandCampina (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05418491

Collaborator

(none)

551

Enrollment

Locations

24.5

Anticipated Duration (Months)

183.7

Patients Per Site

7.5

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Allergy	Other: No intervention is used in the current study. Interventions were given in the original A.R.T. study

Detailed Description

Study Design

Study Type:

Observational

Anticipated Enrollment :

551 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

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

Anticipated Study Start Date :

Jul 15, 2022

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 63 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
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

Sponsors and Collaborators

FrieslandCampina

Investigators

Principal Investigator: Yannis Manios, Dr., Harokopio University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

FrieslandCampina

ClinicalTrials.gov Identifier:

NCT05418491

Other Study ID Numbers:

A.R.T. Follow-Up

First Posted:

Jun 14, 2022

Last Update Posted:

Jul 15, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by FrieslandCampina

post-intervention, allergic manifestations

Additional relevant MeSH terms:

Hypersensitivity

Study Results

No Results Posted as of Jul 15, 2022