Food AllergyNCT05080127
The Feasibility of Systemic Reaction After Contact Exposure to the Allergenic Food in Children With Known Food Allergy
A study testing application of the allergenic food in people with Food Allergy and Quality of Life, run by Meir Medical Center at 2 sites in Israel.
Trial summary
The prevalence of food allergy in the western world is a growing health problem. The majority of reactions are caused due to oral exposure to the known food allergen. However, there are reports about allergic symptoms after exposure to the allergenic food by contact and/ or inhalation. Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Allergy, Quality of Life
- What is being tested?
- application of the allergenic food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesIsrael
- Study dates
- 28 Jul 2021to Dec 2023
- Phase
- Interventional
- 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 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children aged one year to 18 years old with proven food allergy to one of the foods mentioned above.
Who cannot join
- under 12 months of age
- Admitted in the past in intensive care unit after allergic reaction
- Had allergic reaction that treated with three or more adrenalin doses (EpiPen/ IM adrenaline)
- Uncontrolled asthma (according to the GINA guidelines)
- Severe AD
- Children with allergy to three or more allergens not from the same allergen group
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Allergy and Clinical Immunology Unit
Kfar Saba
Idit Lachover- Roth, MD, 972-54-3152585, idit.roth@clalit.org.il
- Recruiting
Meir medical center
Kfar Saba
Idit Lachover - Roth, MD, 972-54-3152585, idit.roth@clalit.org.il
About this study
The prevalence of food allergy in the western world is a growing health problem. The majority of reactions are caused due to oral exposure to the known food allergen. However, there are reports about allergic symptoms after exposure to the allergenic food by contact and/ or inhalation. Most of those reports are subjective without an objective report of healthcare professionals. There are only a few prospective studies that observed objectively the "reliability" of those subjective reports. The estimated chance for systemic allergic reaction due to skin prick test with fresh food is 0.008%, and even then it will not cause anaphylaxis that will need epinephrine use. That evidence is in concordance with our experience. Even with all the information gathered, a study that examines the chance of systemic reaction after skin contact with the allergenic food is still missing.
Additionally, lately, researchers start to examine the influence of food allergy on the quality of life (QOL) of allergic children and their parents. As expected, all studies show negative effects on QOL. The major concern of the parents is from random exposure and severe allergic reaction due to contact with the allergenic food. As far as the investigators know, no study examined the influence of supervised contact with allergenic food on the fear of the child and his parents.
The study aims to evaluate the risk for a systemic allergic reaction after skin exposure to allergenic food in children with known food allergy.
Read the detailed description
The prevalence of food allergy in the western world is estimated at 8% and is constantly raising. The majority of reactions are caused due to oral exposure to the known food allergen. However, there are reports about allergic symptoms after exposure to the allergenic food by contact and/ or inhalation. Most of those reports are subjective without an objective report of a healthcare professional. There is one description of a 16-year-old boy with cow's milk allergy (CMA), who developed anaphylaxis from skin exposure to small amount of cow's milk under the supervision of a healthcare professional. There are only a few prospective studies that observed objectively the "reliability" of those subjective reports. In 2003, Simonte SJ et al examine 30 children with known peanut allergy of which 19 reported past reactions after contact/ inhaled exposure to peanuts. They did a supervised exposure to contact and inhalation of peanut butter. They reported only local skin reactions such as redness (10%), itching (17%), and wheal and flare (7%) with no systemic reactions. Other studies examine the allergic reactions to skin contact with peanuts and also did not report on systemic reactions. In one of the studies they examine the allergic reaction to skin contact in 330 children allergic to peanuts and only 41% had a local reaction with no systemic reactions. In the second study, the investigators did the accepted skin prick test (SPT) with peanut and immediate skin application food test (I-SAFT) with peanut butter in 84 children. The investigators did not observe systemic allergic reactions. Only one study examined allergic reactions after contact with cow's milk in children with CMA. The aim of this study was to compare the skin reaction of children with CMA with and without atopic dermatitis (AD). The investigators did not report systemic reactions also. There are few cases reports that described systemic allergic reaction during SPT, all cases were with fish allergy. A large study examined reactions to SPT with fresh food on 1,138 allergic patients. The investigators have shown that the chance of systemic allergic reaction is 0.008%, and none of the cases needed epinephrine. They review other 15 studies and did not find evidence to systemic reaction after SPT except for one study that reported a 0.005% prevalence of systemic reaction to follow SPT with fresh food in infants younger than 6 months of age.
That evidence is in concordance with the investigators experience. Until today, the investigators did not see the systemic reaction after SPT in children with food allergies. Even with all the information gathered, a study that examines the chance of systemic reaction after skin contact with the allergenic food is still missing.
Additionally, lately, researchers start to examine the influence of food allergy on the quality of life (QOL) of allergic children and their parents. As expected, all studies show a negative effect on QOL. The major concern of the parents is from random exposure and severe allergic reaction due to contact with the allergenic food. As far as the investigator know, no study examined the influence of supervised contact with allergenic food on the fear of the child and his parents.
The study aims primarily - to evaluate the risk for a systemic allergic reaction after skin exposure to the allergenic food in children with known food allergies.
secondary - 1. To evaluate the QOL of the parents (and children over 8 years) before and after the contact with the allergenic food.
Methods: 500 children with known food allergy and 100 children without food allergy as a control group. Simultaneously to the regular skin prick tests, a patch test sticker with the allergenic food will be placed on the forearm for 15 minutes. The parents will fill quality of life questionnaire before the tests, a week later, and 2 months later.
expected results - No allergic reaction will occur after the patch test other than mild local reaction. the level of anxiety will be reduced after the tests.
- Conditions
- Food Allergy, Quality of Life
- Being tested
- application of the allergenic food
- Keywords
- food allergy, contact allergic reaction, skin prick test
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of the allergenic foodCombination product
a small amount of the allergenic fresh food will be placed on the forearm using a patch test sticker for 15 minutes. the skin reaction will be measured.
| Study group | Role | What they receive |
|---|---|---|
| study subjects | Experimental | Children with proven IgE-mediated food allergy to one of the allergenic foods described.
Parallel to the skin tests that are done as part of the accepted follow-up:
1. The parents will fill a questionnaire regarding the quality of life (QOL) and another questionnaire regards family and personal relevant medical history.
2. Patch test sticker with the allergenic food will be placed on the forearm for 15 minutes.
3. A week later and 2 months later, the same QOL questionnaire will be sent by e-mail. Receives: Combination Product: application of the allergenic food |
| Control - atopic children | Active comparator | Children with atopic comorbidities except for food allergy (ie. atopic dermatitis, asthma, allergic rhinitis).
1. The parents will fill a questionnaire regarding family and personal relevant medical history and foods that the child is exposed to regularly.
2. Patch test stickers with two of the food allergen list will be placed on the forearm for 15 minutes. Receives: Combination Product: application of the allergenic food |
| Control - healthy children | Active comparator | Children without any atopic comorbidity (ie. atopic dermatitis, asthma, allergic rhinitis, and food allergy).
1. The parents will fill a questionnaire regarding family and personal relevant medical history and foods that the child is exposed to regularly.
2. Patch test stickers with two of the food allergen list will be placed on the forearm for 15 minutes. Receives: Combination Product: application of the allergenic food |
What is being measured
The primary outcome is the main question the study is designed to answer.
reaction to the patch test
systemic or local reaction after the skin test with the patch test
Measured: 15 minutes
Secondary outcomes (1)
change in quality of life
change in the perception of qality of life by the parents after a week and two months from the tests compared to qality of life questionnaire before the test.
Quality of life scale is 0-84 and the highest the score the quality of life is lower.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start28 Jul 2021
- Primary completionJul 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- * study group - 500 children with known food allergy * control groups - A. 50 children with atopic comorbidities but no food allergy. B. 50 children without atopic comorbidities
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, idit roth, Meir Medical Center
- Investigators
- Idit Lachover- Roth, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080127
- Sponsor's protocol ID
- 0355-19-MMC
- Status last verified
- Oct 2021
- First submitted
- 27 Sep 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sicherer SH, Sampson HA. Food allergy: Epidemiology, pathogenesis, diagnosis, and treatment. J Allergy Clin Immunol. 2014 Feb;133(2):291-307; quiz 308. doi: 10.1016/j.jaci.2013.11.020. Epub 2013 Dec 31.
PubMed 24388012Dominguez C, Ojeda I, Crespo JF, Pascual C, Ojeda A, Martin-Esteban M. Allergic reactions following skin contact with fish. Allergy Asthma Proc. 1996 Mar-Apr;17(2):83-7. doi: 10.2500/108854196778645092.
PubMed 8934799McIntyre CL, Sheetz AH, Carroll CR, Young MC. Administration of epinephrine for life-threatening allergic reactions in school settings. Pediatrics. 2005 Nov;116(5):1134-40. doi: 10.1542/peds.2004-1475.
PubMed 16264000Sicherer SH, Furlong TJ, DeSimone J, Sampson HA. The US Peanut and Tree Nut Allergy Registry: characteristics of reactions in schools and day care. J Pediatr. 2001 Apr;138(4):560-5. doi: 10.1067/mpd.2001.111821.
PubMed 11295721Liccardi G, De Falco F, Gilder JA, D'Amato M, D'Amato G. Severe systemic allergic reaction induced by accidental skin contact with cow milk in a 16-year-old boy. A case report. J Investig Allergol Clin Immunol. 2004;14(2):168-71.
PubMed 15301310Dinakar C, Shroba J, Portnoy JM. The transforming power of proximity food challenges. Ann Allergy Asthma Immunol. 2016 Aug;117(2):135-7. doi: 10.1016/j.anai.2016.06.015. No abstract available.
PubMed 27499540Schichter-Konfino V, Almog M, Bamberger E, Berkowitz D, Kessel A. The significance of allergic contact urticaria to milk in children with cow's milk allergy. Pediatr Allergy Immunol. 2015 May;26(3):218-222. doi: 10.1111/pai.12375.
PubMed 25775957Simonte SJ, Ma S, Mofidi S, Sicherer SH. Relevance of casual contact with peanut butter in children with peanut allergy. J Allergy Clin Immunol. 2003 Jul;112(1):180-2. doi: 10.1067/mai.2003.1486.
PubMed 12847496Wainstein BK, Kashef S, Ziegler M, Jelley D, Ziegler JB. Frequency and significance of immediate contact reactions to peanut in peanut-sensitive children. Clin Exp Allergy. 2007 Jun;37(6):839-45. doi: 10.1111/j.1365-2222.2007.02726.x.
PubMed 17517097Wainstein BK, Yee A, Jelley D, Ziegler M, Ziegler JB. Combining skin prick, immediate skin application and specific-IgE testing in the diagnosis of peanut allergy in children. Pediatr Allergy Immunol. 2007 May;18(3):231-9. doi: 10.1111/j.1399-3038.2007.00517.x.
PubMed 17433001Pitsios C, Dimitriou A, Kontou-Fili K. Allergic reactions during allergy skin testing with food allergens. Eur Ann Allergy Clin Immunol. 2009 Aug;41(4):126-8.
PubMed 19877567Pitsios C, Dimitriou A, Stefanaki EC, Kontou-Fili K. Anaphylaxis during skin testing with food allergens in children. Eur J Pediatr. 2010 May;169(5):613-5. doi: 10.1007/s00431-009-1070-5. Epub 2009 Sep 23.
PubMed 19771451Codreanu F, Moneret-Vautrin DA, Morisset M, Guenard L, Rance F, Kanny G, Lemerdy P. The risk of systemic reactions to skin prick-tests using food allergens: CICBAA data and literature review. Eur Ann Allergy Clin Immunol. 2006 Feb;38(2):52-4.
PubMed 16711536Devenney I, Falth-Magnusson K. Skin prick tests may give generalized allergic reactions in infants. Ann Allergy Asthma Immunol. 2000 Dec;85(6 Pt 1):457-60. doi: 10.1016/S1081-1206(10)62571-9.
PubMed 11152165DunnGalvin A, Dubois AE, Flokstra-de Blok BM, Hourihane JO. The effects of food allergy on quality of life. Chem Immunol Allergy. 2015;101:235-52. doi: 10.1159/000375106. Epub 2015 May 21.
PubMed 26022884
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Systemic Reaction After Contact Exposure to the Allergenic Food in Children With Known Food Allergy
- ClinicalTrials.gov ID
- NCT05080127
- Acronym / sponsor ID
- 0355-19-MMC
- Conditions
- Food Allergy, Quality of Life
- Keywords
- food allergy, contact allergic reaction, skin prick test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 15 Oct 2021 (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 prevalence of food allergy in the western world is a growing health problem. The majority of reactions are caused due to oral exposure to the known food allergen. However, there are reports about allergic symptoms after exposure to the allergenic food by contact and/ or inhalation. Most of those reports are subjective without an objective report of healthcare professionals. There are only a few prospective studies that observed objectively the "reliability" of those subjective reports. The estimated chance for systemic allergic reaction due to skin prick test with fresh food is 0.008%, and even then it will not cause anaphylaxis that will need epinephrine use. That evidence is in concordance with our experience. Even with all the information gathered, a study that examines the chance of systemic reaction after skin contact with the allergenic food is still missing.
Additionally, lately, researchers start to examine the influence of food allergy on the quality of life (QOL) of allergic children and their parents. As expected, all studies show negative effects on QOL. The major concern of the parents is from random exposure and severe allergic reaction due to contact with the allergenic food. As far as the investigators know, no study examined the influence of supervised contact with allergenic food on the fear of the child and his parents.
The study aims to evaluate the risk for a systemic allergic reaction after skin exposure to allergenic food in children with known food allergy.
Detailed description
The prevalence of food allergy in the western world is estimated at 8% and is constantly raising. The majority of reactions are caused due to oral exposure to the known food allergen. However, there are reports about allergic symptoms after exposure to the allergenic food by contact and/ or inhalation. Most of those reports are subjective without an objective report of a healthcare professional. There is one description of a 16-year-old boy with cow's milk allergy (CMA), who developed anaphylaxis from skin exposure to small amount of cow's milk under the supervision of a healthcare professional. There are only a few prospective studies that observed objectively the "reliability" of those subjective reports. In 2003, Simonte SJ et al examine 30 children with known peanut allergy of which 19 reported past reactions after contact/ inhaled exposure to peanuts. They did a supervised exposure to contact and inhalation of peanut butter. They reported only local skin reactions such as redness (10%), itching (17%), and wheal and flare (7%) with no systemic reactions. Other studies examine the allergic reactions to skin contact with peanuts and also did not report on systemic reactions. In one of the studies they examine the allergic reaction to skin contact in 330 children allergic to peanuts and only 41% had a local reaction with no systemic reactions. In the second study, the investigators did the accepted skin prick test (SPT) with peanut and immediate skin application food test (I-SAFT) with peanut butter in 84 children. The investigators did not observe systemic allergic reactions. Only one study examined allergic reactions after contact with cow's milk in children with CMA. The aim of this study was to compare the skin reaction of children with CMA with and without atopic dermatitis (AD). The investigators did not report systemic reactions also. There are few cases reports that described systemic allergic reaction during SPT, all cases were with fish allergy. A large study examined reactions to SPT with fresh food on 1,138 allergic patients. The investigators have shown that the chance of systemic allergic reaction is 0.008%, and none of the cases needed epinephrine. They review other 15 studies and did not find evidence to systemic reaction after SPT except for one study that reported a 0.005% prevalence of systemic reaction to follow SPT with fresh food in infants younger than 6 months of age.
That evidence is in concordance with the investigators experience. Until today, the investigators did not see the systemic reaction after SPT in children with food allergies. Even with all the information gathered, a study that examines the chance of systemic reaction after skin contact with the allergenic food is still missing.
Additionally, lately, researchers start to examine the influence of food allergy on the quality of life (QOL) of allergic children and their parents. As expected, all studies show a negative effect on QOL. The major concern of the parents is from random exposure and severe allergic reaction due to contact with the allergenic food. As far as the investigator know, no study examined the influence of supervised contact with allergenic food on the fear of the child and his parents.
The study aims primarily - to evaluate the risk for a systemic allergic reaction after skin exposure to the allergenic food in children with known food allergies.
secondary - 1. To evaluate the QOL of the parents (and children over 8 years) before and after the contact with the allergenic food.
Methods: 500 children with known food allergy and 100 children without food allergy as a control group. Simultaneously to the regular skin prick tests, a patch test sticker with the allergenic food will be placed on the forearm for 15 minutes. The parents will fill quality of life questionnaire before the tests, a week later, and 2 months later.
expected results - No allergic reaction will occur after the patch test other than mild local reaction. the level of anxiety will be reduced after the tests.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- * study group - 500 children with known food allergy * control groups - A. 50 children with atopic comorbidities but no food allergy. B. 50 children without atopic comorbidities
| Arm | Type | Receives |
|---|---|---|
| study subjects | Experimental | Combination Product: application of the allergenic foodChildren with proven IgE-mediated food allergy to one of the allergenic foods described. Parallel to the skin tests that are done as part of the accepted follow-up: 1. The parents will fill a questionnaire regarding the quality of life (QOL) and another questionnaire regards family and personal relevant medical history. 2. Patch test sticker with the allergenic food will be placed on the forearm for 15 minutes. 3. A week later and 2 months later, the same QOL questionnaire will be sent by e-mail. |
| Control - atopic children | Active comparator | Combination Product: application of the allergenic foodChildren with atopic comorbidities except for food allergy (ie. atopic dermatitis, asthma, allergic rhinitis). 1. The parents will fill a questionnaire regarding family and personal relevant medical history and foods that the child is exposed to regularly. 2. Patch test stickers with two of the food allergen list will be placed on the forearm for 15 minutes. |
| Control - healthy children | Active comparator | Combination Product: application of the allergenic foodChildren without any atopic comorbidity (ie. atopic dermatitis, asthma, allergic rhinitis, and food allergy). 1. The parents will fill a questionnaire regarding family and personal relevant medical history and foods that the child is exposed to regularly. 2. Patch test stickers with two of the food allergen list will be placed on the forearm for 15 minutes. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children aged one year to 18 years old with proven food allergy to one of the foods mentioned above.
Key exclusion criteria (6 listed)
- under 12 months of age
- Admitted in the past in intensive care unit after allergic reaction
- Had allergic reaction that treated with three or more adrenalin doses (EpiPen/ IM adrenaline)
- Uncontrolled asthma (according to the GINA guidelines)
- Severe AD
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 |
|---|---|---|
| application of the allergenic fooda small amount of the allergenic fresh food will be placed on the forearm using a patch test sticker for 15 minutes. the skin reaction will be measured. | Combination product | Control - atopic children, Control - healthy children, study subjects |
Primary outcome
reaction to the patch test
Time frame: 15 minutes
systemic or local reaction after the skin test with the patch test
1 secondary outcome
change in quality of life
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Background: PubMed 24388012Sicherer SH, Sampson HA. Food allergy: Epidemiology, pathogenesis, diagnosis, and treatment. J Allergy Clin Immunol. 2014 Feb;133(2):291-307; quiz 308. doi: 10.1016/j.jaci.2013.11.020. Epub 2013 Dec 31.
- Background: PubMed 8934799Dominguez C, Ojeda I, Crespo JF, Pascual C, Ojeda A, Martin-Esteban M. Allergic reactions following skin contact with fish. Allergy Asthma Proc. 1996 Mar-Apr;17(2):83-7. doi: 10.2500/108854196778645092.
- Background: PubMed 16264000McIntyre CL, Sheetz AH, Carroll CR, Young MC. Administration of epinephrine for life-threatening allergic reactions in school settings. Pediatrics. 2005 Nov;116(5):1134-40. doi: 10.1542/peds.2004-1475.
- Background: PubMed 11295721Sicherer SH, Furlong TJ, DeSimone J, Sampson HA. The US Peanut and Tree Nut Allergy Registry: characteristics of reactions in schools and day care. J Pediatr. 2001 Apr;138(4):560-5. doi: 10.1067/mpd.2001.111821.
- Background: PubMed 15301310Liccardi G, De Falco F, Gilder JA, D'Amato M, D'Amato G. Severe systemic allergic reaction induced by accidental skin contact with cow milk in a 16-year-old boy. A case report. J Investig Allergol Clin Immunol. 2004;14(2):168-71.
- Background: PubMed 27499540Dinakar C, Shroba J, Portnoy JM. The transforming power of proximity food challenges. Ann Allergy Asthma Immunol. 2016 Aug;117(2):135-7. doi: 10.1016/j.anai.2016.06.015. No abstract available.
- Background: PubMed 25775957Schichter-Konfino V, Almog M, Bamberger E, Berkowitz D, Kessel A. The significance of allergic contact urticaria to milk in children with cow's milk allergy. Pediatr Allergy Immunol. 2015 May;26(3):218-222. doi: 10.1111/pai.12375.
- Background: PubMed 12847496Simonte SJ, Ma S, Mofidi S, Sicherer SH. Relevance of casual contact with peanut butter in children with peanut allergy. J Allergy Clin Immunol. 2003 Jul;112(1):180-2. doi: 10.1067/mai.2003.1486.
- Background: PubMed 17517097Wainstein BK, Kashef S, Ziegler M, Jelley D, Ziegler JB. Frequency and significance of immediate contact reactions to peanut in peanut-sensitive children. Clin Exp Allergy. 2007 Jun;37(6):839-45. doi: 10.1111/j.1365-2222.2007.02726.x.
- Background: PubMed 17433001Wainstein BK, Yee A, Jelley D, Ziegler M, Ziegler JB. Combining skin prick, immediate skin application and specific-IgE testing in the diagnosis of peanut allergy in children. Pediatr Allergy Immunol. 2007 May;18(3):231-9. doi: 10.1111/j.1399-3038.2007.00517.x.
- Background: PubMed 19877567Pitsios C, Dimitriou A, Kontou-Fili K. Allergic reactions during allergy skin testing with food allergens. Eur Ann Allergy Clin Immunol. 2009 Aug;41(4):126-8.
- Background: PubMed 19771451Pitsios C, Dimitriou A, Stefanaki EC, Kontou-Fili K. Anaphylaxis during skin testing with food allergens in children. Eur J Pediatr. 2010 May;169(5):613-5. doi: 10.1007/s00431-009-1070-5. Epub 2009 Sep 23.
- 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.
Idit Lachover- Roth, MD principal investigator
Meir Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing application of the allergenic food in people with Food Allergy and Quality of Life, run by Meir Medical Center at 2 sites in Israel.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Contact Idit Lachover- Roth, MD (972-54-3152585, idit.roth@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reaction to the patch test (time frame: 15 minutes). 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 NCT05080127, which also lists 15 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 26 Oct 2021.