Michigan Food and Atopic Dermatitis (M-FAD) Program - Molecular Analytics Project

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Not applicable

Age range

10 years - 55 years

Sex eligible

All sexes

Healthy volunteers

Accepted

Participants

200 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not randomized

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

University of Michigan

Study start

Feb 15, 2024 Actual

Primary completion

2028-03 Estimated

Study completion

2028-03 Estimated

First posted

Mar 8, 2024 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts