Clinical Trials Logo
  1. Home
  2. Allergy
  3. NCT05418491
  4. Details
NCT05418491 Clinical Trial

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
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Terminated NCT02032056 - Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period N/A
Completed NCT01842711 - Cumulative Irritation Patch Test N/A
Completed NCT01633840 - New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges N/A
Completed NCT00997971 - Growth, Tolerance in Healthy Infants Fed a Partially Hydrolyzed Rice Protein Phase 3
Completed NCT00554983 - Efficacy and Safety From a Recombinant Folding Variant of Bet v 1 Phase 3
Completed NCT00331929 - Respiratory Health Study of Children in Kiryat Tivon N/A
Completed NCT00220753 - Air Cleaners for Children and Adolescents With Asthma and Dog Allergy N/A
Completed NCT00232518 - Randomised Controlled Clinical Trials of the Effect of Therapeutic Hookworm Infection in Allergic Rhinoconjunctivitis N/A
Completed NCT04046731 - Neuromuscular Blocking Agents Utilized During Perioperative Hypersensitivity Evaluation N/A
Completed NCT04126096 - Negative Predictive Value and NIC of Beta-Lactam Antibiotics. N/A
Completed NCT04004351 - Treatment Modalities in Children and Adolescents Suffering From HDM-induced Allergic Rhinitis and/or Asthma
Not yet recruiting NCT05997784 - Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing
Not yet recruiting NCT04071821 - Relative Bioavailability Study to Evaluate Cetirizine HCl Gummy 10 mg and Cetirizine HCl Oral Tablets 10 mg Phase 1
Completed NCT04418999 - Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus Early Phase 1
Completed NCT04186949 - Early Origins of Allergy and Asthma
Completed NCT02127801 - Single Ascending-dose Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Participants Phase 1
Enrolling by invitation NCT05011071 - The Alberta BLOOM Premature Child Study
Not yet recruiting NCT06330974 - Allergy, Asthma, and Atopic Eczema in Finland
Completed NCT02596321 - A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic Asthma Phase 3
Terminated NCT02601690 - Observational Analysis of T Cell Responses to SPIREs for Multiple Allergens in Subjects With Allergy in North America