Molecular Analysis of Eczema and Food Allergy

Recruiting in Palo Alto (17 mi)

Overseen by Chase Schuler, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Michigan

Must not be taking: Antihistamines, Biologics

Disqualifiers: Cardiovascular, Cancer, Pulmonary, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

You may need to stop taking certain medications temporarily, like antihistamines, for one week before the oral food challenge. If you're on biologic medications, you shouldn't have started or stopped them within the last 6 months.

What data supports the effectiveness of the M-FAD Program - Molecular Analytics Project treatment for eczema and food allergy?

Research shows that effective treatment of eczema, such as using topical tacrolimus, can reduce concerns about food allergies in children. This suggests that managing eczema well may help alleviate related food allergy worries. ^{1 2 3 4 5}

How does this treatment for eczema and food allergy differ from others?

This treatment is unique because it focuses on understanding the molecular and genetic factors that contribute to eczema and food allergy, using advanced multi-omics approaches. This could lead to more precise and personalized treatment options compared to traditional methods that do not consider these detailed biological insights. ^{1 2 6 7 8}

Research Team

Chase Schuler, MD

Principal Investigator

University of Michigan

Eligibility Criteria

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.

Inclusion Criteria

I have a food allergy and also suffer from eczema.

Control Group: No history of food allergy or atopic dermatitis, past or present

Food allergy-only group: 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

Exclusion Criteria

I do not have skin conditions like psoriasis that could affect the study.

I don't have severe heart, lung, or other conditions that would stop me from joining the study.

I am not pregnant or at risk of becoming pregnant.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Sample Collection

Blood and skin samples are collected from participants at baseline

1 day

1 visit (in-person)

Oral Food Challenge

Participants may undergo a clinically indicated oral food challenge with additional blood and skin samples collected

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the oral food challenge

14 days

Treatment Details

Interventions

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

Trial Overview 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.

Participant Groups

Group I: Food allergy-only group Experimental Treatment 3 Interventions

Participation will be approximately 14 days after enrollment.

Group II: Food allergy plus atopic dermatitis group Experimental Treatment 3 Interventions

Participation will be approximately 14 days after enrollment.

Group III: Control group Adult Experimental Treatment 3 Interventions

Participation will be approximately 14 days after enrollment.

Group IV: Control Group less than 18 years old Experimental Treatment 2 Interventions

Participation will be approximately 14 days after enrollment.

Group V: Atopic dermatitis without food allergy group Experimental Treatment 3 Interventions

Participation will be approximately 14 days after enrollment.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Marschall S. Runge

University of Michigan

Chief Executive Officer since 2015

MD, PhD

Karen McConnell

University of Michigan

Chief Medical Officer since 2020

MD

Findings from Research

The SunBEAm birth cohort is a large-scale study aiming to enroll 2500 infants to investigate the mechanisms and environmental factors contributing to food allergies (FA) and atopic dermatitis (AD) from birth to 3 years of age.

This study utilizes a comprehensive systems biology approach, collecting a wide range of biological samples and data to better understand the development of allergies, focusing on common allergens like egg, milk, and peanut.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The SunBEAm birth cohort: Protocol design. Keet, C., Sicherer, SH., Bunyavanich, S., et al.[2023]

In a study of 23 children with atopic dermatitis (AD) and suspected food allergies, effective treatment with topical tacrolimus significantly reduced parental concerns about food allergies, with concern ratings dropping from 7.7 to 4.0 on a 10-point scale (P < .001).

The number of reported food reactions decreased by approximately 80% during the treatment period, suggesting that successful management of AD can alleviate misconceptions about food allergies and encourage a focus on skin care rather than dietary restrictions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective therapy of childhood atopic dermatitis allays food allergy concerns. Thompson, MM., Hanifin, JM.[2013]

About 40% of infants and young children with moderate to severe atopic dermatitis (AD) have food allergies, highlighting the need for careful identification of these patients through appropriate testing and supervised food challenges.

Removing the identified food allergens can lead to significant clinical improvement in AD, but it requires careful education to avoid nutritional deficits, as many common allergens are prevalent in the diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food hypersensitivity and atopic dermatitis: pathophysiology, epidemiology, diagnosis, and management. Sicherer, SH., Sampson, HA.[2019]

Skincare interventions, primarily using emollients in infants, probably do not prevent eczema by the age of 1-3 years, based on a meta-analysis of 17 trials involving 5823 participants.

These interventions may increase the risk of local skin infections, indicating a potential safety concern, with a relative risk of 1.34 based on data from 2728 participants across 6 trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skincare interventions in infants for preventing eczema and food allergy: A cochrane systematic review and individual participant data meta-analysis. Kelleher, MM., Cro, S., Van Vogt, E., et al.[2022]

Food allergies (FA) are increasingly common in children, affecting nearly 8% and are a leading cause of anaphylaxis, highlighting the need for better understanding and management of this complex disease.

Recent advancements in high-throughput omics technologies (like genomics and proteomics) are being used to identify potential biomarkers for food allergies, which could improve diagnosis and lead to more personalized treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-omics profiling approach in food allergy. Devonshire, A., Gautam, Y., Johansson, E., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

The SunBEAm birth cohort: Protocol design. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Endotypes of atopic dermatitis and food allergy. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Effective therapy of childhood atopic dermatitis allays food allergy concerns. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Food hypersensitivity and atopic dermatitis: pathophysiology, epidemiology, diagnosis, and management. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Food-Related Contact Dermatitis, Contact Urticaria, and Atopy Patch Test with Food. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Current insights into the genetics of food allergy. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Skincare interventions in infants for preventing eczema and food allergy: A cochrane systematic review and individual participant data meta-analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Multi-omics profiling approach in food allergy. [2023]