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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04186949
Other study ID # ACT172097
Secondary ID 170925013
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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