Early Origins of Allergy and Asthma (ARIES)

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Allergy; Atopic Dermatitis; Food Allergy; Allergic Sensitisation

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 Type: Observational
• Enrollment (Actual): 273

Contacts and Locations

Study Locations

• Chile
  • RM
    • Santiago, RM, Chile, 8330077
      • Pontificia Universidad Catolica de Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women living in Chile's central regions (i.e. mothers), their partners (i.e. fathers), and their offspring.

Description

Inclusion Criteria:

• Pregnant women living in Chile's central regions
• Offspring of women recruited in the cohort study

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of allergic diseases in offspring	Atopic dermatitis, food allergy, allergic sensitization, predicted increased risk of asthma	2 years

Collaborators and Investigators

• Sponsor: Pontificia Universidad Catolica de Chile
• Collaborators: University of Chile; Comisión Nacional de Investigación Científica y Tecnológica
• Investigators: Study Director: Arturo Borzutzky, M.D., Pontificia Universidad Catolica de Chile; Principal Investigator: Paul Harris, M.D., Pontificia Universidad Catolica de Chile; Principal Investigator: Paola Casanello, PhD, Pontificia Universidad Catolica de Chile; Principal Investigator: José A Castro-Rodriguez, M.D. PhD, Pontificia Universidad Catolica de Chile

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: birth cohort; Chile
• Additional Relevant MeSH Terms: Skin Diseases; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Dermatitis; Food Hypersensitivity
• Other Study ID Numbers: ACT172097; 170925013 (Other Identifier: Comité Ético Científico, Pontificia Universidad Católica de Chile)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No