Systems Biology of Early Atopy

Running, not enrolling

Conditions studied: Allergic Diseases, Food Allergy, Atopic Dermatitis

In brief

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

Key facts

Study ID

NCT04798079

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

2500

Starts

2021-03-18

Expected to finish

2032-07-01

Last updated by the study team

2026-05-27

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Pregnant Women-
• Pregnant women who meet all of the following criteria are eligible for enrollment as study participants:
• Age 18 years or older
• Able to understand the oral and written instructions associated with study visits and procedures and provide informed consent
• Pregnant at any stage
• Planning to give birth at a study-site designated center
• Agrees to enroll offspring into the study at birth
• In the case of multiple gestation, agrees to enroll only one child who will be selected by randomized birth order
• Biological Fathers-
• Biological fathers who meet all of the following criteria are eligible for enrollment as study participants:
• Age 18 years or older
• Able to understand the oral and written instructions associated with study visits and procedures and provide informed consent

You may not qualify if…

• Pregnant Women-
• Pregnant women who meet any of these criteria are not eligible for enrollment:
• Inability or unwillingness to comply with study protocol
• Serious pregnancy complication (in the judgement of the investigator) prior to enrollment
• Fetus has a major chromosomal anomaly
• Plans to move and would not be available for in-person visits at a study site
• Plans to give up her child for adoption at birth
• Pregnancy is the result of an egg donation
• Infants-
• Infants who meet any of these criteria are not eligible for enrollment:
• Delivered earlier than 34 weeks of gestation
• Sibling already enrolled
• Born with a significant birth defect or medical condition, and in the judgment of the investigators, participation is not in the infant's best interest
• Biological Father-
• Biological fathers who are unable or unwilling to comply with the study protocol as it pertains to the biological father's participation are not eligible for enrollment
• ---Note Regarding Legal Guardians who are not the Biological Parents:
• At screening for enrollment of either the mother or the child, if the biological mother intends to give the infant up for adoption, neither the mother nor the child are eligible for enrollment
• If the biological mother gives up legal guardianship of the child during the child's follow-up period, the child may remain enrolled as long as the new legal guardian:
• Agrees to meet the child's study requirements, and
• Provides written informed consent for the child's continued participation.
• Throughout the protocol where it refers to the mother, father, or parent answering questionnaires about the child or collecting samples from the child and the child's primary home, the legal guardian who provides consent for the child's participation may complete those procedures

Where it is running

• 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

Full record on ClinicalTrials.gov

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