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Molecular Analysis of Eczema and Food Allergy
N/A
Recruiting
Led By Chase Schuler, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 4 hours (day 1 during the food challenge)
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to investigate the relationship between atopic dermatitis and food allergy. By collecting blood and skin samples from participants, the study seeks to understand if these conditions have common genetic or biochemical markers that
Who is the study for?
This trial is for people with food allergies to specific items like peanuts or milk, confirmed by an allergist, and those with atopic dermatitis (eczema). It also includes healthy individuals without these conditions. Excluded are those with serious health issues like active cardiovascular disease or cancer, certain medication use that affects test results, other skin conditions besides eczema, recent biologic medication changes, past oral immunotherapy for food allergies, and pregnant women.
What is being tested?
The study aims to find if there's a link between atopic dermatitis (eczema) and food allergy by collecting blood and skin samples from participants. Some may undergo a food challenge where they eat small amounts of the suspected allergen under medical supervision while their biological responses are recorded.
What are the potential side effects?
Potential side effects mainly stem from the Oral Food Challenge which can trigger allergic reactions ranging from mild symptoms like itching or hives to more severe ones such as difficulty breathing or anaphylaxis. Skin biopsies might cause pain, infection risk at the biopsy site.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 4 hours (day 1 during the food challenge)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 4 hours (day 1 during the food challenge)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Anaphylaxis occurrence rates in each group
Secondary study objectives
Anaphylaxis likelihood in each group based on the Brighton score
Anaphylaxis severity in each group
Reaction rates in each group
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Group I: Food allergy-only groupExperimental Treatment3 Interventions
Participation will be approximately 14 days after enrollment.
Group II: Food allergy plus atopic dermatitis groupExperimental Treatment3 Interventions
Participation will be approximately 14 days after enrollment.
Group III: Control group AdultExperimental Treatment3 Interventions
Participation will be approximately 14 days after enrollment.
Group IV: Control Group less than 18 years oldExperimental Treatment2 Interventions
Participation will be approximately 14 days after enrollment.
Group V: Atopic dermatitis without food allergy groupExperimental Treatment3 Interventions
Participation will be approximately 14 days after enrollment.
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,862 Previous Clinical Trials
6,441,267 Total Patients Enrolled
Chase Schuler, MDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
52 Total Patients Enrolled