Early Markers for Atopic Dermatitis and Food Allergy

(SUNBEAM Trial)

Recruiting at 12 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Disqualifiers: Serious pregnancy complication, Major chromosomal anomaly, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

2500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to uncover early markers and biological pathways leading to food allergies and atopic dermatitis (a type of eczema) by studying children from before birth up to age three, or six if continuing in a follow-up study. Researchers will collect samples from both the environment and the body to explore how various factors contribute to these conditions. Pregnant women planning to give birth at a designated study center and willing to enroll their child at birth are well-suited for this trial. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to early interventions for these conditions.

Why are researchers excited about this trial?

Researchers are excited about the Systems Biology of Early Atopy trial because it aims to uncover how biological systems interact in the early stages of atopy, a condition often leading to allergic diseases. Unlike standard treatments that focus directly on symptom management, this study explores the complex network of genes, proteins, and environmental factors involved in the initial development of atopy. By understanding these interactions, scientists hope to identify new targets for therapy that could prevent or more effectively treat allergic conditions from their onset. This systems biology approach is groundbreaking as it looks beyond isolated factors to the bigger picture of how atopy develops and progresses.

Who Is on the Research Team?

Corinne Keet, MD,MS,PhD

Principal Investigator

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

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

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?

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+