Michigan Food and Atopic Dermatitis (M-FAD) Program - Molecular Analytics Project
- Conditions
- Food AllergyHealthyAtopic Dermatitis
- Interventions
- Other: Data and biospecimen collectionOther: Skin biopsiesOther: Oral Food Challenge (OFC) procedures
- Registration Number
- NCT06300697
- Lead Sponsor
- University of Michigan
- Brief Summary
This study will explore potential links between atopic dermatitis and food allergy. This information will be useful to determine atopic dermatitis and food allergy share unique biochemical or genetic identifiers useful for diagnosing and treatments in the future.
This is a mechanistic study consisting of obtaining blood and skin samples from participants at baseline. Individuals may also undergo a clinically indicated oral food challenge and have blood and skin samples collected at various times during the oral food challenge. This study will create a molecular map of the pathology of atopic dermatitis and food allergy. This information will be deployed to evaluate the hypothesis that atopic dermatitis and food allergy share unique genetic transcriptional signals in which the study team can then further analyze pathological pathways and cell types.
- Detailed Description
This study will be funded by the National Institute of Health. Once the funds are received, the registration will be updated with this information.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Adult Skin biopsies Participation will be approximately 14 days after enrollment. Food allergy-only group Oral Food Challenge (OFC) procedures Participation will be approximately 14 days after enrollment. Food allergy plus atopic dermatitis group Oral Food Challenge (OFC) procedures Participation will be approximately 14 days after enrollment. Control group Adult Data and biospecimen collection Participation will be approximately 14 days after enrollment. Food allergy-only group Data and biospecimen collection Participation will be approximately 14 days after enrollment. Atopic dermatitis without food allergy group Data and biospecimen collection Participation will be approximately 14 days after enrollment. Food allergy-only group Skin biopsies Participation will be approximately 14 days after enrollment. Food allergy plus atopic dermatitis group Skin biopsies Participation will be approximately 14 days after enrollment. Atopic dermatitis without food allergy group Skin biopsies Participation will be approximately 14 days after enrollment. Control Group less than 18 years old Oral Food Challenge (OFC) procedures Participation will be approximately 14 days after enrollment. Control group Adult Oral Food Challenge (OFC) procedures Participation will be approximately 14 days after enrollment. Food allergy plus atopic dermatitis group Data and biospecimen collection Participation will be approximately 14 days after enrollment. Atopic dermatitis without food allergy group Oral Food Challenge (OFC) procedures Participation will be approximately 14 days after enrollment. Control Group less than 18 years old Data and biospecimen collection Participation will be approximately 14 days after enrollment.
- Primary Outcome Measures
Name Time Method Anaphylaxis occurrence rates in each group Approximately 4 hours (Day 1 during the food challenge) Anaphylaxis likelihood will be defined by the Brighton criteria. Any Brighton Level 1, 2, or 3 anaphylaxis. Score 1 = definite anaphylaxis, score 2 = probable anaphylaxis, score 3 = possible anaphylaxis.
- Secondary Outcome Measures
Name Time Method Anaphylaxis severity in each group Approximately 4 hours (Day 1 during the food challenge) This will be graded on a scale of 1 to 5 (where 1 = mild, 5 = death) according to criteria set forth in the Consortium for Food Allergy Research (CoFAR) Grading Scale.
Reaction rates in each group Approximately 4 hours (Day 1 during the food challenge) Any objective symptom of allergic reaction occurs (e.g., hives, angioedema, vomiting, wheeze, etc.) not rising to the definition of anaphylaxis.
Anaphylaxis likelihood in each group based on the Brighton score Approximately 4 hours (Day 1 during the food challenge) The Brighton score gives a 0-3 score of anaphylaxis likelihood (0 = no anaphylaxis, 3 = highly likely).
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States