Skin Characteristics of Parents of Food Allergic Pediatric Patients

NCT04198753 | Suspended

• 1 other identifier: HS-3257
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Food Allergy in Children

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• FLG mutation status

  6-12 months

• Vitamin D status

  6-12 months

Study Arms (2)

Parent of Peanut Allergic Child

The researchers will identify patients or study subjects aged 1-18 who have been diagnosed with peanut allergy based on skin prick testing, serologic testing, and/or history of reaction. They will then contact mothers or fathers of these patients/subjects who are 18 and older and enroll those who do not themselves have a history of food allergy, with a goal of 40 subjects per group. The researchers will perform a very limited physical exam followed by skin tape stripping (30 strips) for lipid profile and protein expression, and transepidermal water loss (TEWL) measurements every 5 strips. They will obtain blood work to define FLG mutation and vitamin D status. Questionnaires on their background, other concurrent atopic and nonatopic diseases, and exposures, will also be collected.

Diagnostic Test: Skin tape stripping; Device: Skin barrier assessment; Diagnostic Test: Blood draw

Parent of Non-atopic Child

To establish normal controls, the researchers will enroll parents age 18 or older with no history of food allergy or eczema in themselves or their offspring. The researchers will perform a very limited physical exam followed by skin tape stripping (30 strips) for lipid profile and protein expression, and transepidermal water loss (TEWL) measurements every 5 strips. They will obtain blood work to define FLG mutation and vitamin D status. Questionnaires on their background, other concurrent atopic and nonatopic diseases, and exposures, will also be collected.

Diagnostic Test: Skin tape stripping; Device: Skin barrier assessment; Diagnostic Test: Blood draw

Interventions

Skin tape stripping DIAGNOSTIC_TEST

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.

Parent of Non-atopic Child; Parent of Peanut Allergic Child

Skin barrier assessment DEVICE

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.

Parent of Non-atopic Child; Parent of Peanut Allergic Child

Blood draw DIAGNOSTIC_TEST

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.

Parent of Non-atopic Child; Parent of Peanut Allergic Child

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Peanut allergic patients/subjects will be identified via the NJH EMR or database. Parents may be approached by listed study staff at the beginning or end of their scheduled NJH visit and asked about their food allergy history and interest in enrollment. Alternatively, this may be done over the phone. Thereafter, eligibility will be determined using the listed inclusion and exclusion criteria.

You may qualify if:

• Subject has signed the informed consent form
• years of age or older (inclusive) 3. One of the following Diagnostic Categories:
• Normal healthy controls with no personal or offspring history of food allergy or atopic dermatitis
• 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:
• Involvement of the skin-mucosal tissue (eg, generalized hives, itch-flush, swollen lips-tongue-uvula)
• Respiratory compromise (eg, dyspnea, wheeze-bronchospasm, stridor, reduced PEF, hypoxemia)
• Reduced BP or associated symptoms (eg, hypotonia \[collapse\], syncope, incontinence)
• 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

You may not qualify if:

• Has active flare of atopic dermatitis requiring use of bleach baths, topical corticosteroids, topical immunomodulatory agents, or topical antibiotics on the extremity being evaluated
• 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
• Has a current systemic infection requiring use of systemic antibiotics, antiparasitics, antivirals, or antifungals
• Has a severe concomitant disease or immunosuppression such as lymphoma, HIV, or Wiskott-Aldrich syndrome
• Has a history of a severe reaction to latex, tape, or adhesives
• Has used any biologics within 5 half-lives or 16 weeks, whichever is longer
• Has received immunotherapy in the last 12 months
• Has used any investigational drugs within 5 half-lives or 8 weeks, whichever is longer
• Has used anticoagulants, anxiolytics, or antidepressants within 30 days
• Has used of systemic immunosuppressive drugs including oral steroids within 30 days
• 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
• Is pregnant or lactating (this will be self-verified by the patient)

Sponsors & Collaborators

• National Jewish Health: lead

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Related Publications (4)

• 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.

  PMID: 22464642 BACKGROUND

• Esparza-Gordillo J, Matanovic A, Marenholz I, Bauerfeind A, Rohde K, Nemat K, Lee-Kirsch MA, Nordenskjold M, Winge MC, Keil T, Kruger R, Lau S, Beyer K, Kalb B, Niggemann B, Hubner 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.

  PMID: 25757221 BACKGROUND

• 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. No abstract available.

  PMID: 19748658 BACKGROUND

• Kelleher M, Dunn-Galvin A, Hourihane JO, Murray D, Campbell LE, McLean WHI, 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):930-935.e1. doi: 10.1016/j.jaci.2014.12.013. Epub 2015 Jan 22.

  PMID: 25618747 BACKGROUND

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: December 13, 2019
• Study Start: January 23, 2020
• Primary Completion: June 1, 2020
• Study Completion: October 6, 2020
• Last Updated: April 13, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)