Early Origins of Allergy and Asthma

Completed

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

• Registration Number: NCT04186949
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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.

Study Timeline

• Study Start: 2018-10-09
• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-05
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-03
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 273

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of allergic diseases in offspring	2 years	Atopic dermatitis, food allergy, allergic sensitization, predicted increased risk of asthma

Trial Locations

Locations (1)

Pontificia Universidad Católica de Chile; 🇨🇱 Santiago, RM, Chile