Early Origins of Allergy and Asthma

NCT ID: NCT04186949

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 273 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-09
• Study Completion Date: 2022-12-31

Brief 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 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.

Conditions

Allergy; Asthma; Food Allergy; Allergic Sensitisation; Atopic Dermatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Chile

OTHER

Sponsor Role: collaborator

Comisión Nacional de Investigación Científica y Tecnológica

OTHER_GOV

Sponsor Role: collaborator

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arturo Borzutzky, M.D.

Role: STUDY_DIRECTOR

Pontificia Universidad Catolica de Chile

Paul Harris, M.D.

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile

Paola Casanello, PhD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile

José A Castro-Rodriguez, M.D. PhD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile

Locations

Pontificia Universidad Católica de Chile

Santiago, RM, Chile

Countries

Chile

References

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.

Reference Type: BACKGROUND

PMID: 32293348 (View on PubMed)

Other Identifiers

170925013

Identifier Type: OTHER

Identifier Source: secondary_id

ACT172097

Identifier Type: -

Identifier Source: org_study_id