AllergyARIESNCT04186949
Early Origins of Allergy and Asthma
An observational study of Allergy and Asthma, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
Birth cohort study with recruitment during pregnancy to determine prenatal and perinatal conditions, as well as genetic and epigenetic factors, that participate in the early setting of immune responses, and the role of these in the later determination of the risk of allergic diseases, asthma, and metabolic conditions… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Allergy, Asthma, Food Allergy
- How many people
- 273 participants
- Where
- 1 siteChile
- Study dates
- 9 Oct 2018to 31 Dec 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women living in Chile's central regions (i.e. mothers), their partners (i.e. fathers), and their offspring.
Who may be able to join
- Pregnant women living in Chile's central regions
- Offspring of women recruited in the cohort study
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Birth cohort study with recruitment during pregnancy to determine prenatal and perinatal conditions, as well as genetic and epigenetic factors, that participate in the early setting of immune responses, and the role of these in the later determination of the risk of allergic diseases, asthma, and metabolic conditions in the offspring.
Read the detailed description
Despite recent advances in the understanding of the pathogenesis of allergies and asthma, these diseases still have no clear preventative measures or curative treatments. Growing evidence shows that atopic dermatitis (AD), food allergy (FA), allergic rhinitis, and asthma are largely determined during the first 1000 days (time elapsed from conception to the 2nd birthday). This cohort aims to determine prenatal and perinatal conditions, as well as genetic and epigenetic factors, that participate in the early setting of immune responses, and the role of these in the later determination of the risk of allergic diseases, and asthma in the offspring.
The investigators have designed a birth cohort of 250 families with recruitment in pregnancy (~14 weeks). The plan is to genotype relevant allergy/asthma-associated variants and will perform immunophenotyping and evaluation of allergy biomarkers in cord blood. At 2 years of age the investigators will assess if infants have developed allergic sensitization, AD, FA, as well as biomarkers of asthma including the asthma predictive index. The study will also evaluate how maternal conditions modify immune programming through epigenetic modifications, and will then confirm newborn epigenetic cues of allergy/asthma risk. Next, the investigators will assess composition/diversity of maternal gut, placenta, breastmilk and infant gut microbiome and their association with immunophenotype and biomarkers at birth, and clinical outcomes at age 2. Finally, another specific objective is to assess how environmental exposures (perinatal outdoor and indoor pollution, endotoxin and allergens) affect the incidence of allergic sensitization, AD, FA, and risk of asthma.
- Conditions
- Allergy, Asthma, Food Allergy, Allergic Sensitisation, Atopic Dermatitis
- Keywords
- birth cohort, Chile
- Medical subject headings
- Hypersensitivity, Asthma, Food Hypersensitivity, Dermatitis, Atopic
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of allergic diseases in offspring
Atopic dermatitis, food allergy, allergic sensitization, predicted increased risk of asthma
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start9 Oct 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chile, Comisión Nacional de Investigación Científica y Tecnológica
- Responsible party
- Sponsor
- Investigators
- Arturo Borzutzky, M.D., Study director, Pontificia Universidad Catolica de ChilePaul Harris, M.D., Principal investigator, Pontificia Universidad Catolica de ChilePaola Casanello, PhD, Principal investigator, Pontificia Universidad Catolica de ChileJosé A Castro-Rodriguez, M.D. PhD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186949
- Sponsor's protocol ID
- ACT172097
- Other IDs
- 170925013
- Acronym
- ARIES
- Status last verified
- Mar 2023
- First submitted
- 3 Dec 2019
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hernandez CD, Casanello P, Harris PR, Castro-Rodriguez JA, Iturriaga C, Perez-Mateluna G, Farias M, Urzua M, Hernandez C, Serrano C, Sandoval M, Hoyos-Bachiloglu R, Uauy R, Borzutzky A. Early origins of allergy and asthma (ARIES): study protocol for a prospective prenatal birth cohort in Chile. BMC Pediatr. 2020 Apr 15;20(1):164. doi: 10.1186/s12887-020-02077-x.
PubMed 32293348
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Origins of Allergy and Asthma
- ClinicalTrials.gov ID
- NCT04186949
- Acronym / sponsor ID
- ARIES / ACT172097
- Conditions
- Allergy, Asthma, Food Allergy, Allergic Sensitisation, Atopic Dermatitis
- Keywords
- birth cohort, Chile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- University of Chile, Comisión Nacional de Investigación Científica y Tecnológica
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Dec 2019 (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.
Birth cohort study with recruitment during pregnancy to determine prenatal and perinatal conditions, as well as genetic and epigenetic factors, that participate in the early setting of immune responses, and the role of these in the later determination of the risk of allergic diseases, asthma, and metabolic conditions in the offspring.
Detailed description
Despite recent advances in the understanding of the pathogenesis of allergies and asthma, these diseases still have no clear preventative measures or curative treatments. Growing evidence shows that atopic dermatitis (AD), food allergy (FA), allergic rhinitis, and asthma are largely determined during the first 1000 days (time elapsed from conception to the 2nd birthday). This cohort aims to determine prenatal and perinatal conditions, as well as genetic and epigenetic factors, that participate in the early setting of immune responses, and the role of these in the later determination of the risk of allergic diseases, and asthma in the offspring.
The investigators have designed a birth cohort of 250 families with recruitment in pregnancy (~14 weeks). The plan is to genotype relevant allergy/asthma-associated variants and will perform immunophenotyping and evaluation of allergy biomarkers in cord blood. At 2 years of age the investigators will assess if infants have developed allergic sensitization, AD, FA, as well as biomarkers of asthma including the asthma predictive index. The study will also evaluate how maternal conditions modify immune programming through epigenetic modifications, and will then confirm newborn epigenetic cues of allergy/asthma risk. Next, the investigators will assess composition/diversity of maternal gut, placenta, breastmilk and infant gut microbiome and their association with immunophenotype and biomarkers at birth, and clinical outcomes at age 2. Finally, another specific objective is to assess how environmental exposures (perinatal outdoor and indoor pollution, endotoxin and allergens) affect the incidence of allergic sensitization, AD, FA, and risk of asthma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women living in Chile's central regions (i.e. mothers), their partners (i.e. fathers), and their offspring.
Key inclusion criteria (2 listed)
- Pregnant women living in Chile's central regions
- Offspring of women recruited in the cohort study
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of allergic diseases in offspring
Time frame: 2 years
Atopic dermatitis, food allergy, allergic sensitization, predicted increased risk of asthma
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 7 Feb 2024.
- Background: PubMed 32293348Hernandez CD, Casanello P, Harris PR, Castro-Rodriguez JA, Iturriaga C, Perez-Mateluna G, Farias M, Urzua M, Hernandez C, Serrano C, Sandoval M, Hoyos-Bachiloglu R, Uauy R, Borzutzky A. Early origins of allergy and asthma (ARIES): study protocol for a prospective prenatal birth cohort in Chile. BMC Pediatr. 2020 Apr 15;20(1):164. doi: 10.1186/s12887-020-02077-x.
- 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.
Arturo Borzutzky, M.D. study director
Pontificia Universidad Catolica de Chile
Paul Harris, M.D. principal investigator
Pontificia Universidad Catolica de Chile
Paola Casanello, PhD principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy and Asthma, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 2 inclusion and 1 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 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. 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?
Development of allergic diseases in offspring (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04186949, which also lists 1 linked publication.
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 7 Feb 2024.