Michigan Food and Atopic Dermatitis (M-FAD) Program - Molecular Analytics Project
Atopic Dermatitis · Food Allergy · Healthy
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 10 años - 55 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- Aceptados
- Participantes
- 200 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
This study will be funded by the National Institute of Health. Once the funds are received, the registration will be updated with this information.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Sin asignación al azar
- Enmascaramiento
- Sin enmascaramiento
Control group Adult
Participation will be approximately 14 days after enrollment.
Other: Data and biospecimen collection · Other: Skin biopsies · Other: Oral Food Challenge (OFC) procedures
Food allergy-only group
Participation will be approximately 14 days after enrollment.
Other: Data and biospecimen collection · Other: Skin biopsies · Other: Oral Food Challenge (OFC) procedures
Food allergy plus atopic dermatitis group
Participation will be approximately 14 days after enrollment.
Other: Data and biospecimen collection · Other: Skin biopsies · Other: Oral Food Challenge (OFC) procedures
Atopic dermatitis without food allergy group
Participation will be approximately 14 days after enrollment.
Other: Data and biospecimen collection · Other: Skin biopsies · Other: Oral Food Challenge (OFC) procedures
Control Group less than 18 years old
Participation will be approximately 14 days after enrollment.
Other: Data and biospecimen collection · Other: Oral Food Challenge (OFC) procedures
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Anaphylaxis occurrence rates in each group
Plazo: 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.
Medidas secundarias
Anaphylaxis severity in each group
Plazo: Approximately 4 hours (Day 1 during the food challenge)
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.
Reaction rates in each group
Plazo: Approximately 4 hours (Day 1 during the food challenge)
Any objective symptom of allergic reaction occurs (e.g., hives, angioedema, vomiting, wheeze, etc.) not rising to the definition of anaphylaxis.
Anaphylaxis likelihood in each group based on the Brighton score
Plazo: Approximately 4 hours (Day 1 during the food challenge)
The Brighton score gives a 0-3 score of anaphylaxis likelihood (0 = no anaphylaxis, 3 = highly likely).
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
1 centros
University of MichiganAnn Arbor, Michigan, United StatesReclutando
Equipo y fechas
- Patrocinador principal
- University of Michigan
- Inicio del estudio
- 15 feb 2024 Real
- Finalización primaria
- 2028-03 Estimado
- Finalización del estudio
- 2028-03 Estimado
- Primera publicación
- 8 mar 2024 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Michigan Food and Atopic Dermatitis (M-FAD) Program - Molecular Analytics Project
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026