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

This study, called the Michigan Food and Atopic Dermatitis (M-FAD) Program, is looking into how atopic dermatitis (eczema) and food allergies might be connected. Researchers want to find unique biological signs that could help diagnose and treat these conditions in the future. You could be eligible if you are between 10 and 55 years old and have atopic dermatitis, a food allergy, or are healthy. If you have a food allergy, you must have a confirmed history of anaphylaxis (a severe allergic reaction) to peanut, tree nut, egg, milk, or sesame, and recent allergy testing. The study involves collecting health information, blood samples, and possibly skin biopsies. Some participants may also have an oral food challenge (eating a small amount of a food allergen under medical supervision) to peanut, tree nut, egg, milk, or sesame. The main goal is to see how often anaphylaxis occurs during these food challenges.

Study design: This is an interventional study with a planned enrollment of 200 participants. It is a mechanistic study, meaning it aims to understand how diseases work.
What's involved: You would provide health information and blood samples. You might also have one or two skin biopsies from your forearm, and potentially undergo an oral food challenge lasting approximately 2-4 hours.
Compensation: Not stated in the trial record.
Follow-up: Anaphylaxis occurrence rates are measured at approximately 4 hours during the food challenge on Day 1.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

NAAges 10–55InterventionalBasic science

University of Michigan

~200 participants

Updated 2025-11-25 on ClinicalTrials.gov

What's tested:Data and biospecimen collectionSkin biopsiesOral Food Challenge (OFC) procedures

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Anaphylaxis occurrence rates in each group

Measured over Approximately 4 hours (Day 1 during the food challenge)

Conditions

Atopic Dermatitis

Food Allergy

Healthy

Where it's being run

1 sites across 1 states

Michigan1

Study leadership

Chase Schuler, MD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Bridgette Kaul

[email protected]

734-647-8284

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Have a present diagnosis of atopic dermatitis by an allergist and/or dermatologist.

Have no history of food allergy, past or present.

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.

Exclusion

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.

What this trial measures

Anaphylaxis occurrence rates in each groupApproximately 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.

Trialytics