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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

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ClinicalTrials.gov Identifier: NCT05418491
Recruitment Status : Enrolling by invitation
First Posted : June 14, 2022
Last Update Posted : July 15, 2022
Sponsor:
Information provided by (Responsible Party):
FrieslandCampina

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
Allergy 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.

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Study Type : Observational
Estimated 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
Estimated Study Start Date : July 15, 2022
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Incidence of allergic Manifestations [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 63 Months   (Child)
Sexes Eligible for Study:   All
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).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05418491


Locations
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Bulgaria
Medical University of Varna
Varna, Bulgaria, 9002
Cyprus
Asthma and Allergy Centre LTD
Limassol, Cyprus, 24 Nafpliou Street, 3025
Greece
Harokopio University
Athens, Greece, Thiseos 70, Kallithea 176 71
Sponsors and Collaborators
FrieslandCampina
Investigators
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Principal Investigator: Yannis Manios, Dr. Harokopio University
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Responsible Party: FrieslandCampina
ClinicalTrials.gov Identifier: NCT05418491    
Other Study ID Numbers: A.R.T. Follow-Up
First Posted: June 14, 2022    Key Record Dates
Last Update Posted: July 15, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by FrieslandCampina:
post-intervention, allergic manifestations
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases