Exploring links between food allergies and atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the potential connections between atopic dermatitis and food allergies by collecting blood and skin samples from participants. It includes individuals with known food allergies, those with both food allergies and atopic dermatitis, and a control group without either condition. The research aims to create a molecular map of the pathology associated with these conditions, focusing on unique genetic and biochemical identifiers that could aid in future diagnosis and treatment. Participants may also undergo oral food challenges to gather additional data during the study.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Chase Schuler, MD — University of Michigan
• Study coordinator: Bridgette Kaul
• Email: foodallergyclinicalresearch@med.umich.edu
• Phone: 734-647-8284

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• How lebrikizumab affects the skin microbiome and mycobiome in adults with atopic dermatitis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.