Status:
COMPLETED
Natural History of Severe Allergic Inflammation and Reactions
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
PGM3 Deficiency
Eosinophilic and/or Atopic Dermatitis
Eligibility:
All Genders
2-80 years
Brief 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 chroni...
Detailed Description
Background: Allergic inflammation is central to the pathogenesis of allergic diseases, including atopic dermatitis, asthma, allergic rhinitis, and food allergy. These disorders are common, affecting ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subject or unaffected relatives must:
- 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
- recurrent flares in the preceding 3 months. Patients greater than 21 years of age with a history of disease in the first 5 years of life and/or, if in the opinion of the PI or AIs, the patient would be of interest to fulfill the objectives of the study.
- OR
- Be 2-80 years of age with a known or suspected genetic or congenital disorder associated with severe allergic inflammation or
- hypersensitivity, as determined by the PI or AIs.
- OR
- Be an a relative of a patient enrolled in the protocol.
- Have a private physician to provide local continuity of care.
- Provide a letter of referral, with copies of pertinent medical history and laboratory studies as indicated, from the prospective study participant s referring physician; this is not a requirement for healthy relatives.
- Be willing to donate blood, buccal swabs, saliva, skin and nasal swabs for research and clinical studies and for storage to be used for future research and genetic testing; for unaffected relatives, be willing to donate blood and/or undergo allergy skin testing, in addition to having blood samples stored for future research and genetic testing.
- Pregnant women or women who become pregnant are eligible to participate or continue participation on the study.
- Healthy Volunteer must:
- Be at least 18 years old and no greater than 80 years old, and able to provide informed consent.
- 2\. Have no history of severe or recurrent allergic diseases or reactions.
- Be willing to have samples stored for research and genetic testing.
- EXCLUSION CRITERIA:
- Any subject with any of the following criteria will be excluded:
- Presence of conditions that, in the judgment of the investigator or the referring physician, may put the subject at undue risk or make them unsuitable for participation in the study.
- Inability or refusal to undergo study procedures.
- Inability to participate for the duration of the study.
- Any unaffected relative or healthy volunteer with any of the following criteria will be excluded:
- Presence of conditions that, in the judgment of the investigator or the referring physician, may put the subject at undue risk or make them unsuitable for participation in the study.
- Inability or refusal to undergo study procedures.
- Inability to provide informed consent.
Exclusion
Key Trial Info
Start Date :
July 12 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
945 Patients enrolled
Trial Details
Trial ID
NCT01164241
Start Date
July 12 2010
Last Update
January 8 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892