Systems Biology of Early Atopy (NCT04798079) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Systems Biology of Early Atopy
United States2,500 participantsStarted 2021-03-18
Plain-language summary
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
Who can participate
Age range
0 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Age 18 years or older
. Able to understand the oral and written instructions associated with study visits and procedures and provide informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Immunoglobulin E (IgE)-Mediated, Immediate-Type Food Allergy
Timeframe: From 5 months to 72 months of age
2
Incidence of Atopic Dermatitis (AD)
Timeframe: From 2 months to 72 months of age
Trial details
NCT IDNCT04798079
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)