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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT06300697
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Data and biospecimen collection — OTHER
    Enrolled participants will have health-related information and blood specimens collected.
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Feb 15, 2024
Status verified
Nov 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Bridgette Kaul
[email protected]
734-647-8284
Chase Schuler, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Ann Arbor, MI

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
University of Michigan· Ann Arbor, MI

Related Studies