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

NCT06300697 | Recruiting

• 1 other identifier: HUM00235532
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Anaphylaxis occurrence rates in each group

  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.

  Approximately 4 hours (Day 1 during the food challenge)

Secondary Outcomes (3)

• Anaphylaxis severity in each group

  Approximately 4 hours (Day 1 during the food challenge)

• Reaction rates in each group

  Approximately 4 hours (Day 1 during the food challenge)

• Anaphylaxis likelihood in each group based on the Brighton score

  Approximately 4 hours (Day 1 during the food challenge)

Study Arms (5)

Control group Adult

OTHER

Participation will be approximately 14 days after enrollment.

Other: Data and biospecimen collection; Other: Skin biopsies; Other: Oral Food Challenge (OFC) procedures

Food allergy-only group

OTHER

Participation will be approximately 14 days after enrollment.

Other: Data and biospecimen collection; Other: Skin biopsies; Other: Oral Food Challenge (OFC) procedures

Food allergy plus atopic dermatitis group

OTHER

Participation will be approximately 14 days after enrollment.

Other: Data and biospecimen collection; Other: Skin biopsies; Other: Oral Food Challenge (OFC) procedures

Atopic dermatitis without food allergy group

OTHER

Participation will be approximately 14 days after enrollment.

Other: Data and biospecimen collection; Other: Skin biopsies; Other: Oral Food Challenge (OFC) procedures

Control Group less than 18 years old

OTHER

Participation will be approximately 14 days after enrollment.

Other: Data and biospecimen collection; Other: Oral Food Challenge (OFC) procedures

Interventions

Data and biospecimen collection OTHER

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

Atopic dermatitis without food allergy group; Control Group less than 18 years old; Control group Adult; Food allergy plus atopic dermatitis group; Food allergy-only group

Skin biopsies OTHER

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.

Atopic dermatitis without food allergy group; Control group Adult; Food allergy plus atopic dermatitis group; Food allergy-only group

Oral Food Challenge (OFC) procedures OTHER

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.

Atopic dermatitis without food allergy group; Control Group less than 18 years old; Control group Adult; Food allergy plus atopic dermatitis group; Food allergy-only group

Eligibility Criteria

• Age: 10 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• \- No history of food allergy or atopic dermatitis, past or present.

You may not qualify if:

• People younger than age 10 or older than age 55
• 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 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Food Hypersensitivity; Hypersensitivity

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Chase Schuler, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bridgette Kaul

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine and Assistant Professor of Mary H Weiser Food Allergy

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 8, 2024
• Study Start: February 15, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)