AllergyNCT05418491
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
An observational study of Allergy, run by FrieslandCampina at 3 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 5 years to 63 months
- Conditions the study is for
- Allergy
- How many people
- 455 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 21 Jul 2022to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years to 63 months
- All sexes
- No healthy volunteers
- Child
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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
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.
Read the 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
- Being tested
- No intervention is used in the current study. Interventions were given in the original A.R.T. study
- Keywords
- post-intervention, allergic manifestations
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention is used in the current study. Interventions were given in the original A.R.T. studyOther
The current study is a post-intervention study; interventions were given in the original A.R.T. study
| Study group | Role | What they receive |
|---|---|---|
| Partially hydrolyzed protein Infant formula | Originating from A.R.T. cohort. Receives: Other: No intervention is used in the current study. Interventions were given in the original A.R.T. study | |
| Standard infant formula | Originating from A.R.T. cohort. Receives: Other: No intervention is used in the current study. Interventions were given in the original A.R.T. study | |
| Exclusively breastfed infants | Originating from A.R.T. cohort. Receives: Other: No intervention is used in the current study. Interventions were given in the original A.R.T. study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 5 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start21 Jul 2022
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- FrieslandCampina
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yannis Manios, Dr., Principal investigator, Harokopio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418491
- Sponsor's protocol ID
- A.R.T. Follow-Up
- Status last verified
- Nov 2024
- First submitted
- 10 Jun 2022
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05418491
- Acronym / sponsor ID
- A.R.T. Follow-Up
- Conditions
- Allergy
- Keywords
- post-intervention, allergic manifestations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- FrieslandCampinaIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Partially hydrolyzed protein Infant formula | – | Other: No intervention is used in the current study. Interventions were given in the original A.R.T. studyOriginating from A.R.T. cohort. |
| Standard infant formula | – | Other: No intervention is used in the current study. Interventions were given in the original A.R.T. studyOriginating from A.R.T. cohort. |
| Exclusively breastfed infants | – | Other: No intervention is used in the current study. Interventions were given in the original A.R.T. studyOriginating from A.R.T. cohort. |
Who may qualify
- Ages
- 5 years to 63 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention is used in the current study. Interventions were given in the original A.R.T. studyThe current study is a post-intervention study; interventions were given in the original A.R.T. study | Other | Exclusively breastfed infants, Partially hydrolyzed protein Infant formula, Standard infant formula |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yannis Manios, Dr. principal investigator
Harokopio University
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy, run by FrieslandCampina at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Bulgaria, Cyprus, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of allergic Manifestations (time frame: At 5 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.