CompletedNot Applicable

Natural History of Severe Allergic Inflammation and Reactions

United States945 participantsStarted 2010-07-12

Plain-language summary

Background: \- Allergic inflammation is central to allergy-related diseases and disorders, such as asthma, food allergies, and atopic dermatitis. Atopic dermatitis, commonly called eczema is a chronic, noncontagious skin condition, usually starting in the first years of life, which causes itching and scaling of an individual s skin. Because atopic dermatitis is a common condition in children who have allergy-related diseases, including asthma, researchers are interested in studying both individuals with atopic dermatitis and their close relatives (parents and children) to better understand how allergy-related diseases develop and progress. In addition, some patients with inherited disorders with features including atopic dermatitis or other aspects of allergy such as food allergy, asthma, hay fever, hives, and others, will also be seen. Objectives: \- To study the natural history of diseases of allergic inflammation, such as atopic dermatitis or genetic disorders associated with allergic inflammation. Eligibility: * Children and adolescents between 1 month and 21 years of age who have a documented history of moderate to severe atopic dermatitis. * Individuals between 1 month and 80 years of age who have a suspected genetic or inherited allergy disorder related to atopic dermatitis or allergic pathways. * Child and adult relatives of eligible participants will also be studied on this protocol. Design: * The study will require one initial visit to the National Institutes of Health Clinical Center (lasting 1-5 days), as well as any required follow-up visits for treatment and research studies. Participants will receive treatment for atopic dermatitis and other allergic diseases as part of the study for up to 1 year. * Participants will have some or all of the following tests as part of this study: * A detailed physical examination and medical history * Allergy skin prick testing to examine participants' responses to different allergens. * Blood samples for additional allergen testing, testing the immune system, and other research purposes * Skin punch biopsy to take a skin sample * Lung function tests to measure airflow from the lungs and inflammation * Food-related tests to diagnose potential food allergies * Leukapheresis to collect white blood cells only * Research samples, including stool specimens, saliva samples, buccal swabs (to collect cells from the inside of the cheek), and skin cell samples * Clinical digital photography to provide images of affected and healthy skin. * Participants will be asked to return for follow-up visits and tests for up to 1 year after the initial visit(s).

Who can participate

Age range

2 Years – 80 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

. Be at least 2 years of age and less than or equal to 21 years of age at the time of enrollment and have documented history of severe allergic inflammation or hypersensitivity, that began in the first 5 years of life, that is moderate to severe, and with continued inflammation or
. Be 2-80 years of age with a known or suspected genetic or congenital disorder associated with severe allergic inflammation or
. Be an a relative of a patient enrolled in the protocol.

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

SCORAD

Timeframe: At initial and single follow up visit 1-2 months after.

Trial details

NCT IDNCT01164241

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeOBSERVATIONAL

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