2500 Participants Needed

Systems Biology of Early Atopy

(SUNBEAM Trial)

Recruiting at 12 trial locations
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

CK

Corinne Keet, MD,MS,PhD

Principal Investigator

Div.of Pediatric Allergy, Immunology and Rheumatology, Dept. of Pediatrics, Johns Hopkins School of Medicine

SH

Scott H. Sicherer, MD

Principal Investigator

Div. of Pediatric Allergy and Immunology, Jaffe Food Allergy Institute,Dept. of Pediatrics, Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

Inclusion Criteria

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
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Baseline Assessment

Pregnant women, biological fathers, and offspring are enrolled; baseline biological and environmental samples are collected

From pregnancy to birth
1 visit (in-person)

Early Life Monitoring

Children are assessed for allergic diseases and samples are collected at specified intervals

From birth to 36 months
5 visits (in-person) at ages 2, 5, 12, 24, and 36 months

Extended Monitoring

For participants opting to continue, additional assessments and sample collections occur

From 36 to 72 months
3 visits (in-person) at ages 48, 60, and 72 months

Follow-up

Participants are monitored for long-term outcomes related to allergic diseases

Up to 72 months

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

Consortium for Food Allergy Research

Collaborator

Trials
1
Recruited
2,500+

Rho Federal Systems Division, Inc.

Industry Sponsor

Trials
44
Recruited
15,000+
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