Molecular Analysis of Eczema and Food Allergy

Overseen By Bridgette Kaul

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Antihistamines, Biologics

Disqualifiers: Cardiovascular, Cancer, Pulmonary, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to explore the connection between eczema (atopic dermatitis) and food allergies by examining their biochemical and genetic markers. Participants will provide blood and skin samples and may undergo a food challenge to determine how these conditions are related. Suitable candidates include individuals with a confirmed food allergy (such as peanut or milk) but no eczema, those with both food allergies and eczema, those with only eczema, or those without either condition.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance understanding and treatment of these conditions.

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 prior data suggests that this study's methods are safe?

Research has shown that the Michigan Food and Atopic Dermatitis (M-FAD) Program aims to understand the link between eczema (atopic dermatitis) and food allergies. This study collects blood and skin samples to explore these conditions. It does not test a new drug or treatment, so it lacks the usual risks of experimental therapies.

Since this is not a drug trial, no new medication is being tested that might cause side effects. Instead, the study includes routine medical procedures like taking blood and skin samples, which are generally safe. While these procedures might cause minor discomfort or bruising, most participants handle them well.

This study gathers information, not provides treatment. Therefore, safety concerns are minimal and mainly related to the standard practices of collecting samples. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Molecular Analytics Project within the M-FAD Program because it dives deep into understanding eczema and food allergies at a molecular level. Unlike traditional treatments that focus on managing symptoms, this project aims to uncover the underlying biological mechanisms of these conditions. By analyzing molecular data, scientists hope to identify new biomarkers and potential targets for innovative therapies. This could lead to more personalized and effective treatments, moving beyond the standard options like topical steroids or antihistamines. Ultimately, this trial has the potential to revolutionize how we approach and treat eczema and food allergies.

What evidence suggests that this trial's treatments could be effective for atopic dermatitis and food allergy?

Research has shown that atopic dermatitis (a type of eczema) and food allergies might share common genetic links. This study, which includes various participant groups such as those with food allergies, atopic dermatitis, both conditions, and control groups, aims to explore these connections at a molecular level. Although solid evidence of a direct treatment effect for either condition is not yet available, understanding these genetic links could lead to better diagnosis and more targeted treatments in the future. The study aims to determine if shared pathways or cell types are involved in both conditions, potentially aiding in the development of new therapies. Early findings suggest this approach might identify unique markers for both eczema and food allergies. ^{1 2 4 6 7}

Who Is on the Research Team?

Chase Schuler, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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

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

I have a food allergy and also suffer from eczema.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Genetic studies have identified key genes associated with food allergy (FA), particularly MALT1, FLG, and HLA, which are linked to immune function and barrier integrity, suggesting that these factors play a significant role in FA risk.

Despite challenges in current genetic research, understanding these genetic loci is crucial for uncovering the mechanisms behind FA and could lead to improved prevention and management strategies through integrative approaches combining genetics with other biological data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current insights into the genetics of food allergy. Kanchan, K., Clay, S., Irizar, H., et al.[2022]

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]

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]

Atopic dermatitis (AD) is closely linked to food allergies (FA), with about one-third of children with AD also developing FA, highlighting the importance of understanding the underlying mechanisms connecting these conditions.

Research indicates that genetic factors, environmental exposures, and Staphylococcus aureus colonization contribute to skin barrier dysfunction in AD and FA, suggesting that targeted interventions could improve diagnosis and prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endotypes of atopic dermatitis and food allergy. Hui-Beckman, JW., Goleva, E., Berdyshev, E., et al.[2023]

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]

Certain foods can trigger or worsen skin diseases like atopic dermatitis, and understanding the mechanisms behind these reactions is crucial for effective diagnosis and treatment.

The atopy patch test (APT) is a valuable tool for identifying delayed allergic reactions to food proteins, even in patients who test negative for other common allergy tests, and has been standardized for use in assessing atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food-Related Contact Dermatitis, Contact Urticaria, and Atopy Patch Test with Food. Walter, A., Seegräber, M., Wollenberg, A.[2020]

Citations

1. trials.foodallergy.org trials.foodallergy.org/trials/NCT06300697

Michigan Food and Atopic Dermatitis (M-FAD) Program 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 ...

2. reaganudall.org reaganudall.org/clinical-trial/michigan-food-and-atopic-dermatitis-m-fad-program-molecular-analytics-project

Michigan Food and Atopic Dermatitis (M-FAD) Program This study will explore potential links between atopic dermatitis and food allergy. Thisinformation will be useful to determine atopic dermatitis and.

3. trialx.com trialx.com/clinical-trials/listings/285824/michigan-food-and-atopic-dermatitis-m-fad-program-molecular-analytics-project/

Michigan Food and Atopic Dermatitis (M-FAD) Program This study will explore potential links between atopic dermatitis and food allergy. This information will be useful to determine atopic ...

4. withpower.com withpower.com/trial/phase-dermatitis-dermatitis-atopic-2-2024-bb23a

Molecular Analysis of Eczema and Food Allergy This study will explore potential links between atopic dermatitis and food allergy. This information will be useful to determine atopic dermatitis and food ...

5. medresearch.umich.edu medresearch.umich.edu/labs-departments/centers/food-allergy/research/clinical-trials

Food Allergy Clinical Trials This clinical research study will investigate the safety and effect of a peanut immunotherapy tablet in adults, teenagers and children with a peanut allergy.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06300697/michigan-food-and-atopic-dermatitis-m-fad-program-molecular-analytics-project

Michigan Food and Atopic Dermatitis (M-FAD) Program This study will explore potential links between atopic dermatitis and food allergy. This information will be useful to determine atopic ...

7. medicine.umich.edu medicine.umich.edu/sites/default/files/downloads/AR%20FY%2024_12%2002%202024%20reduce.pdf

Newborns join study to decipher food allergy origins These spaces will support the M-SIBS program, new CoFAR projects, and the Michigan. Food Allergy and Atopic. Dermatitis (M-FAAD) program. From ...