Early Origins of Allergy and Asthma

Asthma Clinical Trial

— ARIES  

Official title:

Early Origins of Allergy and Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04186949
• Other study ID #: ACT172097
• Secondary ID: 170925013
• Status: Completed
• Start date: October 9, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 in the offspring.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant women living in Chile's central regions

• Offspring of women recruited in the cohort study

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Allergic Sensitisation
• Allergy
• Asthma
• Atopic Dermatitis
• Dermatitis
• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Locations

Country	Name	City	State
Chile	Pontificia Universidad Católica de Chile	Santiago	RM

Sponsors (3)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile	Comisión Nacional de Investigación Científica y Tecnológica, University of Chile

Country where clinical trial is conducted

Chile, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of allergic diseases in offspring	Atopic dermatitis, food allergy, allergic sensitization, predicted increased risk of asthma	2 years