Clinical Trials

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	10 Years - 55 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06300697
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Michigan
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Chase Schuler, MD
Principal Investigator Affiliation	University of Michigan
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Atopic Dermatitis, Food Allergy, Healthy

Additional Details

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

Arms & Interventions