Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This study will be funded by the National Institute of Health. Once the funds are received, the registration will be updated with this information.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group Adult | Other | Participation will be approximately 14 days after enrollment. |
|
| Food allergy-only group | Other | Participation will be approximately 14 days after enrollment. |
|
| Food allergy plus atopic dermatitis group | Other | Participation will be approximately 14 days after enrollment. |
|
| Atopic dermatitis without food allergy group | Other | Participation will be approximately 14 days after enrollment. |
|
| Control Group less than 18 years old | Other | Participation will be approximately 14 days after enrollment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data and biospecimen collection | Other | Enrolled participants will have health-related information and blood specimens collected. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Anaphylaxis severity in each group | This will be graded on a scale of 1 to 5 (where 1 = mild, 5 = death) according to criteria set forth in the Consortium for Food Allergy Research (CoFAR) Grading Scale. | Approximately 4 hours (Day 1 during the food challenge) |
| Reaction rates in each group |
Not provided
Food allergy-only group Inclusion Criteria:
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:
Control Group Inclusion Criteria:
- No history of food allergy or atopic dermatitis, past or present.
Exclusion Criteria for all groups:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bridgette Kaul | Contact | 734-647-8284 | foodallergyclinicalresearch@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Chase Schuler, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D005512 | Food Hypersensitivity |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
Any objective symptom of allergic reaction occurs (e.g., hives, angioedema, vomiting, wheeze, etc.) not rising to the definition of anaphylaxis. |
| Approximately 4 hours (Day 1 during the food challenge) |
| Anaphylaxis likelihood in each group based on the Brighton score | The Brighton score gives a 0-3 score of anaphylaxis likelihood (0 = no anaphylaxis, 3 = highly likely). | Approximately 4 hours (Day 1 during the food challenge) |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |