NCT06300697

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 10 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study will be funded by the National Institute of Health. Once the funds are received, the registration will be updated with this information.

Conditions

• Atopic Dermatitis
• Food Allergy
• Healthy

Interventions

Type	Name	Description
OTHER	Data and biospecimen collection	Enrolled participants will have health-related information and blood specimens collected.
OTHER	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.
OTHER	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.

Timeline

• Start date: 2024-02-15
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2024-03-08
• Last updated: 2025-11-25

Locations

1 site across 1 country: United States