This study will explore potential links between atopic dermatitis and food allergy. Thisinformation will be useful to determine atopic dermatitis and food allergy share uniquebiochemical or genetic identifiers useful for diagnosing and treatments in the future.This is a mechanistic study consisting of obtaining blood and skin samples fromparticipants at baseline. Individuals may also undergo a clinically indicated oral foodchallenge and have blood and skin samples collected at various times during the oral foodchallenge. This study will create a molecular map of the pathology of atopic dermatitisand food allergy. This information will be deployed to evaluate the hypothesis thatatopic dermatitis and food allergy share unique genetic transcriptional signals in whichthe study team can then further analyze pathological pathways and cell types.
This study will be funded by the National Institute of Health. Once the funds are
received, the registration will be updated with this information.
Other: Data and biospecimen collection
Enrolled participants will have health-related information and blood specimens collected.
Other: Skin biopsies
Participants will be asked to provide one or two skin biopsies (days 1 and 2) from the
forearm, unless the participant is a healthy child (no food allergy and no atopic
dermatitis), in which case there will be no skin biopsy.
Other: Oral Food Challenge (OFC) procedures
Participants will have the choice of consenting to an OFC (approximately 2-4 hours) to
peanut, tree nut, egg, milk, or sesame. If there is no allergy history, the study team
will conduct an oral food challenge to one of the choices. The OFC will occur in the
clinical research area. and done the same as a clinical care OFC. A transepidermal water
loss monitor will be applied to participant's arm with a sticky pad and will stay on the
arm for the challenge. Food doses will be given in small amounts that increase in size up
to a defined single serving of the food based upon the participants age/size. The OFC
will proceed until a full dose is consumed without symptoms, or until anaphylaxis occurs.
Depending upon the participant's reaction to the oral food challenge, the participant may
be requested to return the next day for a research visit that would take less than an
hour. The 24-hour post oral food challenge visit will include an interview to assess
condition and a blood sample.
Food allergy-only group Inclusion Criteria:
- Have a known history of food anaphylaxis to peanut, tree nut, egg, milk, or sesame
confirmed by an allergist.
- Have had skin and blood food allergy testing to the food allergen in question within
the past 6 months. Meet the 80% likelihood positive predictive value threshold for
allergy based on at least 1 of either the skin or blood immunoglobulin E (IgE) tests
per current literature corrected for age. See protocol for more details.
- No history of atopic dermatitis
Food allergy plus atopic dermatitis group Inclusion Criteria:
- Meet the "food allergy only group" inclusion criteria except this group must also
have atopic dermatitis.
Atopic dermatitis without food allergy Inclusion Criteria:
- Have a present diagnosis of atopic dermatitis by an allergist and/or dermatologist.
- Have no history of food allergy, past or present.
Control Group Inclusion Criteria:
- No history of food allergy or atopic dermatitis, past or present.
Exclusion Criteria for all groups:
- People younger than age 10 or older than age 55
- Any active cardiovascular disease, cancer, pulmonary disease except well-controlled
asthma, or other condition that would preclude an OFC otherwise. Mild conditions
that would not preclude an OFC are allowed (i.e., controlled hypertension or a
surgically removed skin cancer that is resolved would not be exclusionary for this
study, for example).
- Any medication use that cannot be stopped temporarily for the OFC that would
interfere with the OFC result. Medications in this category include antihistamines
(first or second generation) within 1 week.
- Any skin condition aside from atopic dermatitis per inclusion criteria groups that
might impact the study, including such conditions as autoimmune skin conditions
(such as psoriasis), congenital ichthyoses, hyper-IgE syndromes.
- Any recent change (within 6 months) of starting or stopping a biologic medication,
such as dupilumab, tezepelumab, or others that might interfere with atopic
dermatitis or food allergy.
- Any past or present history of oral immunotherapy (OIT) for any food allergen.
- Pregnancy - females of childbearing age will be asked and self-report pregnancy
status.
University of Michigan
Ann Arbor, Michigan, United States
Investigator: Bridgette Kaul
Contact: 734-647-8284
foodallergyclinicalresearch@med.umich.edu
Investigator: Chase Schuler, MD
Bridgette Kaul
734-647-8284
foodallergyclinicalresearch@med.umich.edu
Chase Schuler, MD, Principal Investigator
University of Michigan