Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
62 participants
OBSERVATIONAL
2017-06-12
2018-01-31
Brief Summary
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Detailed Description
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Those with atopic dermatitis (AD) often have food allergy and Staphylococcus aureus (S. aureus) colonization of the skin. There is evidence suggesting that skin barrier dysfunction, measurable as increased transepidermal water loss (TEWL), is a predisposing factor to food sensitization and food allergy from epicutaneous penetration of environmental food allergens. Furthermore, the investigators for this study have identified that AD children with food allergy, especially peanut allergy, are colonized with Staphylococcus aureus. However, only half (50%) of children with AD have food allergy or S. aureus colonization, suggesting there are other factors accounting for food allergy. There have been no previous studies of TEWL or, microbial or molecular profiling of the skin in those with AD prone to food allergy versus AD without food allergy.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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AD and Peanut Food Allergy
Participants with active Atopic Dermatitis (AD) and food allergy to peanut.\* Twenty participants ages 4 to 17 years of age will be enrolled in this group.
\*Peanut skin prick test wheal ≥ 8 mm.
No interventions assigned to this group
AD and No Food Allergy
Participants with active Atopic Dermatitis (AD) and no food allergy.\* Twenty participants ages 4 to 17 years of age will be enrolled in this group.
\*Negative skin prick test (wheal \< 3 mm) to peanut, milk, egg, wheat, soy, shellfish mix, tree nuts, and sesame seed.
No interventions assigned to this group
Non-Atopic Health Control
Participants that are non-atopic, healthy controls\*. Twenty participants ages 4 to 17 years of age will be enrolled in this group.
\*Negative for Atopic Dermatitis (AD), asthma, or allergic rhinitis; negative for food allergy; and negative by skin prick test to peanut, milk, egg, wheat, soy, shellfish mix, tree nuts, and sesame seed, and negative to environmental allergens - cat, dog, dust mite, cockroach, and local trees/grasses/weeds/molds.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
-Parent/guardian must be able to understand and provide informed consent and participant provide assent as applicable per Institutional Review Board (IRB) guidelines and regulations;
For Eligibility to One of the Two Active Atopic Dermatitis (AD) Groups:
-Active Atopic Dermatitis (AD) without a history or current manifestations of eczema herpeticum (EH), as diagnosed using the Atopic Dermatitis Registry
Network (ADRN) Standard Diagnostic Criteria and food allergy to peanut. Participant must meet all of the following criteria:
* Self-report or documentation of a positive oral food challenge to peanut or self-report of an allergic reaction to peanut within 2 hours of ingestion
* Peanut skin prick test wheal ≥ 8 mm. OR -Active AD without a history or current manifestations of EH, as diagnosed using ADRN Standard Diagnostic Criteria and no food allergy.
Participant must meet all of the following criteria:
* No personal history or current manifestations of food allergy (based on no self-report of a positive oral food challenge, positive skin test, positive blood test, or allergic reactions).
* Negative skin prick test (wheal \< 3 mm) to peanut, milk, egg, wheat, soy, shellfish mix, tree nuts, and sesame seed.
For Non-atopic (NA) Group Eligibility:
Participant must meet all of the following criteria:
* No personal history or current manifestations of AD, asthma, or allergic rhinitis (based on self-report);
* No personal history or current manifestations of food allergy (based on no self- report of a positive oral food challenge, positive skin test, positive blood test, or allergic reactions);
* Negative skin prick test (wheal \< 3 mm) to peanut, milk, egg, wheat, soy, shellfish mix, tree nuts, and sesame seed; and
* Negative skin prick test (wheal \< 3 mm) to environmental allergens (cat, dog, dust mite, cockroach, and local trees/grasses/weeds/molds).
Exclusion Criteria
* Subjects with skin disease other than AD that might compromise the stratum corneum barrier (e.g., bullous diseases, psoriasis, cutaneous T cell lymphoma \[also called Mycosis Fungoides or Sezary syndrome\], dermatitis herpetiformis, Hailey- Hailey, or Darier's disease);
* Pregnant or lactating females;
* Known or suspected immunosuppression;
* Severe concomitant illness(es);
* History of serious life-threatening reaction to latex, tape, or adhesives;
* Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study;
* Use of biologics within 5 half-lives (if known) or 16 weeks of the Screening Visit;
* Use of an investigational drug within 5 half-lives (if known) or 8 weeks of the Screening Visit; or
* Has received immunotherapy within 12 months of the Screening Visit.
4 Years
17 Years
ALL
Yes
Sponsors
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Atopic Dermatitis Research Network
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Donald Leung, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Jewish Health: Division of Pediatric Allergy and Clinical Immunology
Locations
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National Jewish Health: Division of Pediatric Allergy and Clinical Immunology
Denver, Colorado, United States
Countries
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References
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Lyubchenko T, Collins HK, Goleva E, Leung DYM. Skin tape sampling technique identifies proinflammatory cytokines in atopic dermatitis skin. Ann Allergy Asthma Immunol. 2021 Jan;126(1):46-53.e2. doi: 10.1016/j.anai.2020.08.397. Epub 2020 Sep 5.
Related Links
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National Institute of Allergy and Infectious Diseases (NIAID) Website
Other Identifiers
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DAIT ADRN-10
Identifier Type: -
Identifier Source: org_study_id