Food Allergy in Children Clinical Trial
Official title:
Skin Characteristics of Parents of Food Allergic Pediatric Patients
NCT number | NCT04198753 |
Other study ID # | HS-3257 |
Secondary ID | |
Status | Suspended |
Phase | |
First received | |
Last updated | |
Start date | January 23, 2020 |
Est. completion date | October 6, 2020 |
Verified date | April 2020 |
Source | National Jewish Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | National Jewish Health | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
National Jewish Health |
United States,
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
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 |
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