Clinical trialNCT04798079Active, not recruitingObservational

Systems Biology of Early Atopy

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment2,500Allergic DiseasesAtopic DermatitisFood Allergy

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The goal of this study is to establish a birth cohort that collects prenatal and early life biosamples and environmental samples and rigorously phenotypes young children for food allergy and Atopic Dermatitis (AD) to identify prenatal and early life markers of high risk for food allergy and AD, as well as biological pathways (endotypes) that result in these conditions. Primary Objectives: * To study the role and interrelationships of established and novel clinical, environmental, biological, and genetic prenatal and early-life factors in the development and course of allergic diseases through age 3 years (or 6 years for those who choose to continue participation into SUNBEAM II), with an emphasis on atopic dermatitis and food allergy * To apply systems biology to identify mechanisms and biomarkers underlying the development of food allergy, atopic dermatitis, and their endotypes * To collect, process, and assay or store environmental and biological samples for current and future use in the study of allergic disease development

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Corinne Keet, MD,MS,PhD
Div.of Pediatric Allergy, Immunology and Rheumatology, Dept. of Pediatrics, Johns Hopkins School of Medicine
Study Chair
clinicaltrials.gov ↗
Scott H. Sicherer, MD
Div. of Pediatric Allergy and Immunology, Jaffe Food Allergy Institute,Dept. of Pediatrics, Icahn School of Medicine at Mount Sinai
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

13 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Arkansas Children'S Hospital
Little Rock, Arkansas, United States
Sean N. Parker Center for Allergy & Asthma Research at Stanford University
Stanford, California, United States
National Jewish Health
Denver, Colorado, United States
Northwestern University Feinberg School of Medicine: Dept of Dermatology
Chicago, Illinois, United States
Johns Hopkins Children'S Center, Department of Allergy & Immunology
Baltimore, Maryland, United States
Massachusetts General Hospital, Translational and Clinical Research Center
Boston, Massachusetts, United States
Henry Ford Health System, Division of Allergy and Immunology
Detroit, Michigan, United States
Kravis Children'S Hospital, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai
New York, New York, United States
North Carolina Children'S Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology
Chapel Hill, North Carolina, United States
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, United States
Vanderbilt University Medical Center Department of Pediatrics Division of Pediatric Allergy, Immunology, and Pulmonary Medicine
Nashville, Tennessee, United States
Texas Children'S Hospital
Houston, Texas, United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 18 Mar 2021
Primary completion: 31 Jul 2032
Completion: 31 Jul 2032
Last update posted: 27 May 2026
Registered enrollment: 2,500
Registry id: NCT04798079

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.