Atopic DermatitisNCT06300697
Michigan Food and Atopic Dermatitis (M-FAD) Program - Molecular Analytics Project
A study testing Data and biospecimen collection, Skin biopsies and Oral Food Challenge (OFC) procedures in people with Atopic Dermatitis and Food Allergy, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Food Allergy, Healthy
- What is being tested?
- Data and biospecimen collection, Skin biopsies and Oral Food Challenge (OFC) procedures
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Bridgette Kaul, 734-647-8284, foodallergyclinicalresearch@med.umich.edu
Chase Schuler, MD
About this study
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.
Read the 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
- Being tested
- Data and biospecimen collection, Skin biopsies, Oral Food Challenge (OFC) procedures
- Keywords
- Blood Samples, Skin Samples, Transepidermal water loss (TEWL) monitor, Allergic reaction
- Medical subject headings
- Dermatitis, Atopic, Food Hypersensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data and biospecimen collectionOther
Enrolled participants will have health-related information and blood specimens collected.
Skin biopsiesOther
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) proceduresOther
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 group | Role | What they receive |
|---|---|---|
| Control group Adult | Other | Participation will be approximately 14 days after enrollment. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Data and biospecimen collection; Other: Oral Food Challenge (OFC) procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 4 hours (Day 1 during the food challenge)
Secondary outcomes (3)
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.
Measured: Approximately 4 hours (Day 1 during the food challenge)
Reaction rates in each group
Any objective symptom of allergic reaction occurs (e.g., hives, angioedema, vomiting, wheeze, etc.) not rising to the definition of anaphylaxis.
Measured: 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).
Measured: Approximately 4 hours (Day 1 during the food challenge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start15 Feb 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles (Chase) Schuler, University of Michigan
- Investigators
- Chase Schuler, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300697
- Sponsor's protocol ID
- HUM00235532
- Status last verified
- Nov 2025
- First submitted
- 1 Mar 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Michigan Food and Atopic Dermatitis (M-FAD) Program - Molecular Analytics Project
- ClinicalTrials.gov ID
- NCT06300697
- Acronym / sponsor ID
- HUM00235532
- Conditions
- Atopic Dermatitis, Food Allergy, Healthy
- Keywords
- Blood Samples, Skin Samples, Transepidermal water loss (TEWL) monitor, Allergic reaction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control group Adult | Other | Other: Data and biospecimen collection, Other: Skin biopsies, Other: Oral Food Challenge (OFC) proceduresParticipation will be approximately 14 days after enrollment. |
| Food allergy-only group | Other | Other: Data and biospecimen collection, Other: Skin biopsies, Other: Oral Food Challenge (OFC) proceduresParticipation will be approximately 14 days after enrollment. |
| Food allergy plus atopic dermatitis group | Other | Other: Data and biospecimen collection, Other: Skin biopsies, Other: Oral Food Challenge (OFC) proceduresParticipation will be approximately 14 days after enrollment. |
| Atopic dermatitis without food allergy group | Other | Other: Data and biospecimen collection, Other: Skin biopsies, Other: Oral Food Challenge (OFC) proceduresParticipation will be approximately 14 days after enrollment. |
| Control Group less than 18 years old | Other | Other: Data and biospecimen collection, Other: Oral Food Challenge (OFC) proceduresParticipation will be approximately 14 days after enrollment. |
Who may qualify
- Ages
- 10 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data and biospecimen collectionEnrolled participants will have health-related information and blood specimens collected. | Other | 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 biopsiesParticipants 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 | Atopic dermatitis without food allergy group, Control group Adult, Food allergy plus atopic dermatitis group, Food allergy-only group |
| Oral Food Challenge (OFC) proceduresParticipants 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. | Other | 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 |
Primary outcome
Anaphylaxis occurrence rates in each group
Time frame: Approximately 4 hours (Day 1 during the food challenge)
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.
3 secondary outcomes
Anaphylaxis severity in each group
Time frame: Approximately 4 hours (Day 1 during the food challenge)
Reaction rates in each group
Time frame: Approximately 4 hours (Day 1 during the food challenge)
Anaphylaxis likelihood in each group based on the Brighton score
Time frame: Approximately 4 hours (Day 1 during the food challenge)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chase Schuler, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data and biospecimen collection, Skin biopsies and Oral Food Challenge (OFC) procedures in people with Atopic Dermatitis and Food Allergy, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bridgette Kaul (734-647-8284, foodallergyclinicalresearch@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anaphylaxis occurrence rates in each group (time frame: Approximately 4 hours (Day 1 during the food challenge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.