Food Allergy in ChildrenNCT04198753
Skin Characteristics of Parents of Food Allergic Pediatric Patients
An observational study of Food Allergy in Children, run by National Jewish Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Allergy in Children
- What is being tested?
- Skin tape stripping, Skin barrier assessment and Blood draw
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2020to 6 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Subject has signed the informed consent form
- 18 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:
- 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)
Show all 11Show fewer
- 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)
- Positive skin prick testing > 8 mm
- Positive specific IgE to peanut > 14.0 kUA/L
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Food Allergy in Children
- Being tested
- Skin tape stripping, Skin barrier assessment, Blood draw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin tape strippingDiagnostic 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.
Skin barrier assessmentDevice
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.
Blood drawDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Skin tape stripping; Device: Skin barrier assessment; Diagnostic Test: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6-12 months
Secondary outcomes (2)
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.
Measured: 6-12 months
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.
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start23 Jan 2020
- Primary completion1 Jun 2020 (estimated)
- Study completion6 Oct 2020 (estimated)
Why it stopped: COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Food Allergy in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198753
- Sponsor's protocol ID
- HS-3257
- Status last verified
- Apr 2020
- First submitted
- 12 Nov 2019
- Last updated
- 13 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22464642Esparza-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.
PubMed 25757221Broccardo 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.
PubMed 19748658Kelleher 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.
PubMed 25618747
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Characteristics of Parents of Food Allergic Pediatric Patients
- ClinicalTrials.gov ID
- NCT04198753
- Acronym / sponsor ID
- HS-3257
- Conditions
- Food Allergy in Children
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: COVID-19 pandemic
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 6 Oct 2020 (estimated)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent of Peanut Allergic Child | – | Diagnostic Test: Skin tape stripping, Device: Skin barrier assessment, Diagnostic Test: Blood drawThe 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. |
| Parent of Non-atopic Child | – | Diagnostic Test: Skin tape stripping, Device: Skin barrier assessment, Diagnostic Test: Blood drawTo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- Subject has signed the informed consent form
- 18 years of age or older (inclusive) 3. One of the following Diagnostic Categories:
- Positive skin prick testing > 8 mm
- Positive specific IgE to peanut > 14.0 kUA/L
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin tape strippingAdhesive 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. | Diagnostic test | Parent of Non-atopic Child, Parent of Peanut Allergic Child |
| Skin barrier assessmentA 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. | Device | Parent of Non-atopic Child, Parent of Peanut Allergic Child |
| Blood drawSubjects 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. | Diagnostic test | Parent of Non-atopic Child, Parent of Peanut Allergic Child |
Primary outcome
Skin barrier dysfunction via skin tape stripping (STS)
Time frame: 6-12 months
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.
Skin barrier dysfunction via transepidermal water loss (TEWL) measurements
Time frame: 6-12 months
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.
2 secondary outcomes
FLG mutation status
Time frame: 6-12 months
Vitamin D status
Time frame: 6-12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Background: PubMed 22464642Lack 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.
- Background: PubMed 25757221Esparza-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.
- Background: PubMed 19748658Broccardo 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.
- Background: PubMed 25618747Kelleher 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy in Children, run by National Jewish Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin barrier dysfunction via skin tape stripping (STS) (time frame: 6-12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04198753, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2020.