Allergic DiseasesSUNBEAMNCT04798079
Systems Biology of Early Atopy
An observational study of Allergic Diseases and Food Allergy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Diseases, Food Allergy, Atopic Dermatitis
- How many people
- 2,500 participants
- Where
- 13 sitesUnited States
- Study dates
- 18 Mar 2021to Jul 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will include pregnant women, their offspring from birth until age 3 years or 6 years, and the offspring's biological father. Although biological fathers will be recruited, their enrollment is not required. The women will be recruited from OB/GYN and prenatal clinics and offices. Other than the eligibility criteria listed, women will not be selected by any criteria or characteristics. The intent is to recruit a study population of children of varying risks with regards to the development of allergic diseases. The rationale is to identify risk factors in the population for the development of allergic disease. Selection of pregnant women whose offspring are at an elevated risk of allergic disease would prevent the study of the risk factors used to select the women.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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-
- 1. 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Johns Hopkins Children's Center, Department of Allergy & Immunology
Baltimore, Maryland, 21287
Massachusetts General Hospital, Translational and Clinical Research Center
Boston, Massachusetts, 02114
North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology
Chapel Hill, North Carolina, 27599
Northwestern University Feinberg School of Medicine: Dept of Dermatology
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
National Jewish Health
Denver, Colorado, 80206
Henry Ford Health System, Division of Allergy and Immunology
Detroit, Michigan, 48202
Texas Children's Hospital
Houston, Texas, 77030
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792
Vanderbilt University Medical Center Department of Pediatrics Division of Pediatric Allergy, Immunology, and Pulmonary Medicine
Nashville, Tennessee, 37232
Kravis Children's Hospital, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Sean N. Parker Center for Allergy & Asthma Research at Stanford University
Stanford, California, 94040
About this study
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
Read the detailed description
This is a prospective cohort study in which pregnant women (at any stage of pregnancy), the offspring's biologic father, and the offspring will be enrolled at study sites, and the offspring will be observed from birth to age 3 years. Enrollment of biological fathers will be attempted; however, enrollment of the mother or child is not dependent on enrollment of the biological father. The enrollment goal is at least 2500 mothers and their offspring having reached 12 months on study. Additionally, families will be offered the opportunity for the child participant to continue SUNBEAM through age 6 via the SUNBEAM II continuation protocol.
During the study, biological and environmental samples and questionnaire information will be collected from the parents and the children, and the children will be assessed for allergic diseases at clinic visits at ages 2, 5, 12, 24, and 36 months and for those who opt to continue participation, at 48, 60, and 72 months.
- Conditions
- Allergic Diseases, Food Allergy, Atopic Dermatitis
- Keywords
- birth cohort, risk factors, systems biology
- Medical subject headings
- Food Hypersensitivity, Dermatitis, Atopic
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Immunoglobulin E (IgE)-Mediated, Immediate-Type Food Allergy
To understand the early life origin and risk factors of child's IgE-mediated, immediate-type food allergy.
Based upon clinical assessments and diagnostic criteria for food allergy, in accordance with the Food Allergy Algorithm, per protocol.
Measured: From 5 months to 72 months of age
Incidence of Atopic Dermatitis (AD)
To understand the early life origin and risk factors of child's atopic dermatitis (AD).
Atopic dermatitis is defined as the following since the last assessment (or since birth for the 2- and 5-month visits):
- A history of a dry or itchy rash that is (a) either continuous or intermittent lasting at least 4 weeks OR (b) requiring medicated treatment AND
- The rash was or is present in the skin creases (folds of elbows, behind the knees, fronts of ankles, or around the neck) or on the extensor aspects of the forearms or lower legs or on cheeks or trunk.
Any infant fulfilling these criteria but who, on examination by a suitably trained health professional, is deemed to have a different skin disease that explains the above findings will be classified as not having atopic dermatitis.
Measured: From 2 months to 72 months of age
Secondary outcomes (8)
Incidence of Sensitization to Protocol-Specified Foods
To understand the early life origin and risk factors of child's food allergy.
Sensitization to food allergens will be assessed using standard diagnostic methods: serum immunoglobulin E (IgE) testing and skin prick testing.
Measured: From 5 months to 72 months of age
Incidence of Sensitization to Aeroallergens
To understand the early life origin and risk factors of child's sensitization to aeroallergens, a risk factor for the development and severity of asthma.
Sensitization to aeroallergens will be assessed using standard diagnostic methods: serum immunoglobulin E (IgE) testing and skin prick testing.
Measured: From 12 months to 72 months of age
Incidence of Recurrent Wheeze
To understand the early life origin and risk factors of child's recurrent wheezing.
Recurrent wheeze, assessed at age 3 years, will be defined as at least two episodes of wheezing during the first three years of life, with at least one episode between the ages of 24 and 36 months
Measured: Up to 36 months of age
Incidence of Seasonal Allergic Rhinitis
To understand the early life origin and risk factors of child's seasonal allergic rhinitis, a seasonal allergic reaction to pollen.
Defined by diagnostic criteria established for the Inner-City Asthma Consortium, per protocol.
Measured: From 24 to 72 months of age
Incidence of Seasonal Allergic Conjunctivitis
To understand the early life origin and risk factors of child's seasonal allergic conjunctivitis, a form of eye allergy.
Defined by diagnostic criteria established for the Inner-City Asthma Consortium, per protocol.
Measured: From 24 to 72 months of age
Incidence of Perennial Allergic Rhinitis
To understand the early life origin and risk factors of child's perennial allergic rhinitis, characterized by nasal symptoms such as sneezing and runny nose that are present year round.
Defined by diagnostic criteria established for the Inner-City Asthma Consortium, per protocol.
Measured: From 24 to 72 months of age
Incidence of Perennial Allergic Conjunctivitis
To understand the early life origin and risk factors of child's perennial allergic rhinitis, characterized by nasal symptoms such as sneezing and runny nose that are present year round.
Defined by diagnostic criteria established for the Inner-City Asthma Consortium, per protocol.
Measured: From 24 to 72 months of age
Incidence of Asthma
To understand the early life origin and risk factors of child's asthma, characterized by wheezing and other respiratory symptoms. The determination of asthma will follow criteria from the Urban Environment and Childhood Asthma (URECA) study.
Measured: 72 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start18 Mar 2021
- Primary completionJul 2032 (estimated)
- Study completionJul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic DiseasesStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Consortium for Food Allergy Research, Rho Federal Systems Division, Inc.
- Responsible party
- Sponsor
- Investigators
- Corinne Keet, MD,MS,PhD, Study chair, Div.of Pediatric Allergy, Immunology and Rheumatology, Dept. of Pediatrics, Johns Hopkins School of MedicineScott H. Sicherer, MD, Study chair, Div. of Pediatric Allergy and Immunology, Jaffe Food Allergy Institute,Dept. of Pediatrics, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798079
- Sponsor's protocol ID
- DAIT CoFAR-12
- Other IDs
- NIAID CRMS ID#:, UM2AI130836
- Acronym
- SUNBEAM
- Status last verified
- May 2026
- First submitted
- 5 Mar 2021
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Biology of Early Atopy
- ClinicalTrials.gov ID
- NCT04798079
- Acronym / sponsor ID
- SUNBEAM / DAIT CoFAR-12
- Conditions
- Allergic Diseases, Food Allergy, Atopic Dermatitis
- Keywords
- birth cohort, risk factors, systems biology
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Consortium for Food Allergy Research, Rho Federal Systems Division, Inc.
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- Jul 2032 (estimated)
- Study completion
- Jul 2032 (estimated)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a prospective cohort study in which pregnant women (at any stage of pregnancy), the offspring's biologic father, and the offspring will be enrolled at study sites, and the offspring will be observed from birth to age 3 years. Enrollment of biological fathers will be attempted; however, enrollment of the mother or child is not dependent on enrollment of the biological father. The enrollment goal is at least 2500 mothers and their offspring having reached 12 months on study. Additionally, families will be offered the opportunity for the child participant to continue SUNBEAM through age 6 via the SUNBEAM II continuation protocol.
During the study, biological and environmental samples and questionnaire information will be collected from the parents and the children, and the children will be assessed for allergic diseases at clinic visits at ages 2, 5, 12, 24, and 36 months and for those who opt to continue participation, at 48, 60, and 72 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include pregnant women, their offspring from birth until age 3 years or 6 years, and the offspring's biological father. Although biological fathers will be recruited, their enrollment is not required. The women will be recruited from OB/GYN and prenatal clinics and offices. Other than the eligibility criteria listed, women will not be selected by any criteria or characteristics. The intent is to recruit a study population of children of varying risks with regards to the development of allergic diseases. The rationale is to identify risk factors in the population for the development of allergic disease. Selection of pregnant women whose offspring are at an elevated risk of allergic disease would prevent the study of the risk factors used to select the women.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (21 listed)
- Pregnant Women-
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Immunoglobulin E (IgE)-Mediated, Immediate-Type Food Allergy
Time frame: From 5 months to 72 months of age
To understand the early life origin and risk factors of child's IgE-mediated, immediate-type food allergy. Based upon clinical assessments and diagnostic criteria for food allergy, in accordance with the Food Allergy Algorithm, per protocol.
Incidence of Atopic Dermatitis (AD)
Time frame: From 2 months to 72 months of age
To understand the early life origin and risk factors of child's atopic dermatitis (AD). Atopic dermatitis is defined as the following since the last assessment (or since birth for the 2- and 5-month visits): 1. A history of a dry or itchy rash that is (a) either continuous or intermittent lasting at least 4 weeks OR (b) requiring medicated treatment AND 2. The rash was or is present in the skin creases (folds of elbows, behind the knees, fronts of ankles, or around the neck) or on the extensor aspects of the forearms or lower legs or on cheeks or trunk. Any infant fulfilling these criteria but who, on examination by a suitably trained health professional, is deemed to have a different skin disease that explains the above findings will be classified as not having atopic dermatitis.
8 secondary outcomes
Incidence of Sensitization to Protocol-Specified Foods
Time frame: From 5 months to 72 months of age
Incidence of Sensitization to Aeroallergens
Time frame: From 12 months to 72 months of age
Incidence of Recurrent Wheeze
Time frame: Up to 36 months of age
Incidence of Seasonal Allergic Rhinitis
Time frame: From 24 to 72 months of age
Incidence of Seasonal Allergic Conjunctivitis
Time frame: From 24 to 72 months of age
Incidence of Perennial Allergic Rhinitis
Time frame: From 24 to 72 months of age
Incidence of Perennial Allergic Conjunctivitis
Time frame: From 24 to 72 months of age
Incidence of Asthma
Time frame: 72 months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- NIAID Division of Allergy, Immunology, and TransplantationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne Keet, MD,MS,PhD study chair
Div.of Pediatric Allergy, Immunology and Rheumatology, Dept. of Pediatrics, Johns Hopkins School of Medicine
Scott H. Sicherer, MD study chair
Div. of Pediatric Allergy and Immunology, Jaffe Food Allergy Institute,Dept. of Pediatrics, Icahn School of Medicine at Mount Sinai
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Diseases and Food Allergy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Immunoglobulin E (IgE)-Mediated, Immediate-Type Food Allergy (time frame: From 5 months to 72 months of age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.