Recruiting

Observational Study

Sponsor:

University of Michigan

Code:

NCT06300697

Conditions

Atopic Dermatitis

Food Allergy

Healthy

Eligibility Criteria

Sex: All

Age: 10 - 55

Healthy Volunteers: Accepted

Interventions

Data and biospecimen collection

Skin biopsies

Oral Food Challenge (OFC) procedures

Study Details

Brief summary:

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.

Conditions

Atopic Dermatitis

Food Allergy

Healthy

Study ID

NCT06300697

Start date

Feb 15, 2024

Status verified date

Nov, 2025

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Control group Adult

Participation will be approximately 14 days after enrollment.

other: Food allergy-only group

Participation will be approximately 14 days after enrollment.

other: Food allergy plus atopic dermatitis group

Participation will be approximately 14 days after enrollment.

other: Atopic dermatitis without food allergy group

Participation will be approximately 14 days after enrollment.

other: Control Group less than 18 years old

Participation will be approximately 14 days after enrollment.

Interventions

Data and biospecimen collection

Enrolled participants will have health-related information and blood specimens collected.

Skin biopsies

Participants will be asked to provide one or two skin biopsies (days 1 and 2) from the forearm, unless the participant is a healthy child (no food allergy and no atopic dermatitis), in which case there will be no skin biopsy.

Oral Food Challenge (OFC) procedures

Participants will have the choice of consenting to an OFC (approximately 2-4 hours) to peanut, tree nut, egg, milk, or sesame. If there is no allergy history, the study team will conduct an oral food challenge to one of the choices. The OFC will occur in the clinical research area. and done the same as a clinical care OFC. A transepidermal water loss monitor will be applied to participant's arm with a sticky pad and will stay on the arm for the challenge. Food doses will be given in small amounts that increase in size up to a defined single serving of the food based upon the participants age/size. The OFC will proceed until a full dose is consumed without symptoms, or until anaphylaxis occurs. Depending upon the participant's reaction to the oral food challenge, the participant may be requested to return the next day for a research visit that would take less than an hour. The 24-hour post oral food challenge visit will include an interview to assess condition and a blood sample.

Primary outcome measure

  • Anaphylaxis occurrence rates in each group [ Time Frame: Approximately 4 hours (Day 1 during the food challenge) ]

Central Contacts and Locations

Central contacts

Bridgette Kaul

734-647-8284foodallergyclinicalresearch@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Bridgette Kaul

734-647-8284foodallergyclinicalresearch@med.umich.edu

Principal Investigator:

Chase Schuler, MD

More Information

Sponsor

University of Michigan

Last update posted

Nov 25, 2025

Last verified

Nov, 2025

Keywords

  • Blood Samples
  • Skin Samples
  • Transepidermal water loss (TEWL) monitor
  • Allergic reaction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2025-11-25.