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Search / Trial NCT06300697

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

Launched by UNIVERSITY OF MICHIGAN · Mar 7, 2024

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Blood Samples Skin Samples Transepidermal Water Loss (Tewl) Monitor Allergic Reaction

ClinConnect Summary

The Michigan Food and Atopic Dermatitis (M-FAD) Program is a research study looking at the possible connections between atopic dermatitis (a type of skin condition) and food allergies. Researchers want to find out if these two conditions share certain biological or genetic markers that could help with diagnosing and treating them in the future. To do this, they will collect blood and skin samples from participants, and some may undergo a food challenge, which is a supervised test to see how the body reacts to specific foods.

To be part of this study, participants should be between the ages of 10 and 55 and meet specific criteria. For example, those with food allergies must have a confirmed history of serious allergic reactions to foods like peanuts or eggs, while individuals with atopic dermatitis should have a diagnosis from a specialist. There are also control participants who have neither condition. Throughout the study, participants can expect to provide samples and possibly participate in food challenges, helping researchers create a detailed understanding of how atopic dermatitis and food allergies may be connected.

Gender

ALL

Eligibility 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.

About University Of Michigan

The University of Michigan, a leading academic institution renowned for its commitment to advancing healthcare and medical research, serves as a prominent clinical trial sponsor. With a robust infrastructure that supports innovative research initiatives, the university leverages its multidisciplinary expertise to conduct a wide array of clinical trials aimed at improving patient outcomes and advancing medical knowledge. Through its state-of-the-art facilities and collaborative environment, the University of Michigan fosters partnerships between researchers, clinicians, and industry leaders, ensuring the development of cutting-edge therapies and interventions that address pressing health challenges.

Locations

Ann Arbor, Michigan, United States

Patients applied

0 patients applied

Trial Officials

Chase Schuler, MD

Principal Investigator

University of Michigan

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported