Skin Characteristics of Parents of Food Allergic Pediatric Patients

Food Allergy in Children Clinical Trial

Official title:

Skin Characteristics of Parents of Food Allergic Pediatric Patients

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04198753
• Other study ID #: HS-3257
• Status: Suspended
• Start date: January 23, 2020
• Est. completion date: October 6, 2020

Study information

• Verified date: April 2020
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine whether disruptions in the skin barrier of parents can contribute to the development of food allergies in their offspring. The study team will compare the superficial skin layers of mothers and fathers who do not have children with diagnosed food allergies to the skin layers of parents who do have children with diagnosed food allergy. The study will include a questionnaire, noninvasive superficial skin testing with skin tapping and transepidermal water loss measurements, and a blood draw.

Description:

There is an already well-established link between atopic dermatitis (AD), or eczema, and the development of food allergies. More specifically, it is believed that sensitizations to food can occur through low-dose cutaneous sensitization via a disrupted skin barrier. The strongest genetic contributor to eczema is the FLG loss-of-function or missense mutation, which is associated with increased transepidermal water loss and increased skin permeability (1). In a recent study exploring the risk of maternal transmission of allergic risk, it was found that children of FLG-carrier mothers had a 1.5 increased AD risk, specifically when these mothers had allergic sensitization (elevated allergen-specific IgE antibody plasma levels) but independent of their own FLG mutation status (10). This information may suggest that an interrupted skin barrier in mothers may serve as an environmental risk factor for the development of food allergies in their offspring.

The purpose of our study is to evaluate the skin characteristics and FLG gene mutation status of parents of known food allergic pediatric patients. The researchers hypothesize that parents of food allergic patients will have more significant disruptions in their skin barrier function than parents of children who do not suffer from food allergies.

In order to evaluate skin barrier disruptions in these subjects, two noninvasive methods will be performed including skin tape stripping, a total of 30 strips per subject, and transepidermal water loss measurements using a small device. Both methods are relatively painless and cause minimal risk to the participant. In order to evaluated FLG gene mutation status, blood draw will also be performed. Subjects will undergo a focused physical exam and also be requested to fill out a detailed questionnaire. The researchers will obtain additional offspring peanut allergy clinical characteristics from the medical records. All data collection will occur over 1-2 visits, averaging an anticipated 1 hour in total duration.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 160
• Est. completion date: October 6, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject has signed the informed consent form

2. 18 years of age or older (inclusive) 3. One of the following Diagnostic Categories:

1. Normal healthy controls with no personal or offspring history of food allergy or atopic dermatitis

2. Mother or father without personal history of food allergy, but with a child diagnosed with peanut allergy. Peanut allergy is defined as fulfilling one of the following 3 criteria:

i. Clinical history defined as one of the following occurring within 2 hours of exposure to peanut:

1. Involvement of the skin-mucosal tissue (eg, generalized hives, itch-flush, swollen lips-tongue-uvula)

2. Respiratory compromise (eg, dyspnea, wheeze-bronchospasm, stridor, reduced PEF, hypoxemia)

3. Reduced BP or associated symptoms (eg, hypotonia [collapse], syncope, incontinence)

4. Persistent gastrointestinal symptoms (eg, crampy abdominal pain, vomiting)

ii. Positive skin prick testing > 8 mm

iii. Positive specific IgE to peanut > 14.0 kUA/L

Exclusion Criteria:

1. Has active flare of atopic dermatitis requiring use of bleach baths, topical corticosteroids, topical immunomodulatory agents, or topical antibiotics on the extremity being evaluated

2. Has a skin disease other than AD that might compromise the stratum corneum barrier such as bullous disease, psoriasis, cutaneous T cell lymphoma, Darier's disease, HaileyHailey, or dermatitis herpetiformis

3. Has a current systemic infection requiring use of systemic antibiotics, antiparasitics, antivirals, or antifungals

4. Has a severe concomitant disease or immunosuppression such as lymphoma, HIV, or Wiskott-Aldrich syndrome

5. Has a history of a severe reaction to latex, tape, or adhesives

6. Has used any biologics within 5 half-lives or 16 weeks, whichever is longer

7. Has received immunotherapy in the last 12 months

8. Has used any investigational drugs within 5 half-lives or 8 weeks, whichever is longer

9. Has used anticoagulants, anxiolytics, or antidepressants within 30 days

10. Has used of systemic immunosuppressive drugs including oral steroids within 30 days

11. Has received total body phototherapy (e.g., ultraviolet light B [UVB], psoralen plus ultraviolet light A [PUVA], tanning beds [>1 visit per week]) within 30 days

12. Is pregnant or lactating (this will be self-verified by the patient)

Related Conditions & MeSH terms

• Food Allergy in Children
• Food Hypersensitivity

Intervention

Diagnostic Test:
• Skin tape stripping
Adhesive skin sampling discs will be firmly pressed against the skin in a hairless location (not the face) followed by lifting it free of the skin. Tape stripping will be collected from non-lesional skin up to 30 times. These discs will then be used to evaluate proteins and lipids. With every 5 tape strips collected, transepidermal water loss measurements will be performed.

Device:
• Skin barrier assessment
A small device will be used to measure transepidermal water loss (TEWL), which is the quantity of water that passes from inside the body through the skin to the surrounding atmosphere via diffusion and evaporation process. The device, a probe, is simply placed against the skin surface making superficial contact and kept there for a few seconds until the measurement terminates. This will be performed at baseline and after every 5 tape strips.

Diagnostic Test:
• Blood draw
Subjects will undergo genetic testing of FLG mutation status (5mL of whole blood in lavender top tube) and vitamin D level (2mL of whole blood in red top tube) via blood draw.

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
National Jewish Health

Country where clinical trial is conducted

United States, 

References & Publications (4)

Broccardo CJ, Mahaffey SB, Strand M, Reisdorph NA, Leung DY. Peeling off the layers: skin taping and a novel proteomics approach to study atopic dermatitis. J Allergy Clin Immunol. 2009 Nov;124(5):1113-5.e1-11. doi: 10.1016/j.jaci.2009.07.057. Epub 2009 Sep 12. — View Citation

Esparza-Gordillo J, Matanovic A, Marenholz I, Bauerfeind A, Rohde K, Nemat K, Lee-Kirsch MA, Nordenskjöld M, Winge MC, Keil T, Krüger R, Lau S, Beyer K, Kalb B, Niggemann B, Hübner N, Cordell HJ, Bradley M, Lee YA. Maternal filaggrin mutations increase the risk of atopic dermatitis in children: an effect independent of mutation inheritance. PLoS Genet. 2015 Mar 10;11(3):e1005076. doi: 10.1371/journal.pgen.1005076. eCollection 2015 Mar. — View Citation

Kelleher M, Dunn-Galvin A, Hourihane JO, Murray D, Campbell LE, McLean WH, Irvine AD. Skin barrier dysfunction measured by transepidermal water loss at 2 days and 2 months predates and predicts atopic dermatitis at 1 year. J Allergy Clin Immunol. 2015 Apr;135(4):930-5.e1. doi: 10.1016/j.jaci.2014.12.013. Epub 2015 Jan 22. — View Citation

Lack G. Update on risk factors for food allergy. J Allergy Clin Immunol. 2012 May;129(5):1187-97. doi: 10.1016/j.jaci.2012.02.036. Epub 2012 Mar 30. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin barrier dysfunction via skin tape stripping (STS)	To determine the level of skin barrier dysfunction in parents of peanut allergic (PA) patients versus parents of nonatopic (no food allergies, atopic dermatitis, or allergic rhinitis) patients using tape stripping.	6-12 months
Primary	Skin barrier dysfunction via transepidermal water loss (TEWL) measurements	To determine the level of skin barrier dysfunction in parents of peanut allergic (PA) patients versus parents of nonatopic (no food allergies, atopic dermatitis, or allergic rhinitis) patients using TEWL assessments.	6-12 months
Secondary	FLG mutation status	To determine filaggrin gene mutation status and evaluate if this correlates to the level of skin barrier dysfunction found on skin tape stripping and TEWL assessments.	6-12 months
Secondary	Vitamin D status	To determine vitamin D status and evaluate if this correlates to the level of skin barrier dysfunction found on skin tape stripping and TEWL assessments.	6-12 months