Exploring links between food allergies and atopic dermatitis
Michigan Food and Atopic Dermatitis (M-FAD) Program - Molecular Analytics Project
This study is trying to see if there are connections between food allergies and atopic dermatitis by looking at blood and skin samples from people with and without these conditions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 10 Years to 55 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Drugs / interventions | dupilumab, tezepelumab, immunotherapy |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06300697 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with a history of food allergies, those with both food allergies and atopic dermatitis, or individuals diagnosed with atopic dermatitis without food allergies.
Not a fit: Patients with neither food allergies nor atopic dermatitis may not receive any benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and treatment strategies for patients suffering from atopic dermatitis and food allergies.
How similar studies have performed: While this study explores a novel approach, previous studies have indicated potential links between food allergies and atopic dermatitis, suggesting that this area of research holds promise.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ann Arbor, Michigan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.