Food AllergyNCT06328504
Efficacy of Cashew Nut Protein Immunotherapy
A study testing Cashew immunotherapy in people with Food Allergy, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
It is a randomized, single-center, controlled trial to evaluate the effectiveness of oral immunotherapy with cashew protein compared with standard treatment (elimination diet) in pediatric patients with cashew allergy. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Food Allergy
- What is being tested?
- Cashew immunotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 sitePoland
- Study dates
- 28 Mar 2024to 21 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age between 4 and 17 years,
- IgE (immunoglobulin E) -mediated cashew allergy confirmed with positive skin prick tests with cashew allergens (diameter of the wheal greater than 3mm) and/or specific IgE (immunoglobulin E) level greater than 0.35-kilo units of Allergen per liter (kUA/l),
- allergic reaction to cashew protein during oral food challenge (OFC),
- Signed Informed Consent by parent/legal guardian and patient aged >16 years old,
- Patient's and caregivers' cooperation with the researcher.
Who cannot join
- no confirmed allergy to cashew,
- negative provocation test with cashew,
- severe asthma,
- mild/moderate asthma poorly controlled: FEV1 (forced expiratory volume at one second) <80% (less than 5 perc), FEV1/FVC (forced expiratory volume at one second/forced vital capacity) <75% (less than 5 perc), hospitalization for asthma exacerbation in the past 12 months,
- oral/sublingual/subcutaneous immunotherapy to other allergens during the study,
- eosinophilic gastroenteritis,
Show all 17Show fewer
- chronic diseases requiring ongoing treatment, including heart disease, epilepsy, metabolic diseases, diabetes,
- taking medications:
- oral, daily steroid therapy >1 month in the past 12 months,
- a minimum of 2 times oral steroid therapy (a period of at least 7 days) in the past 12 months,
- one-time oral steroid therapy (min. 7 days) in the last 3 months,
- biological treatment,
- need to take antihistamines continuously,
- therapy with β-blockers, ACE-inhibitors (angiotensin converting enzyme), calcium channel inhibitors,
- pregnancy,
- lack of consent to participate in the study,
- lack of patient cooperation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-091
Agnieszka Szczukocka-Zych, MD, +48 22 3179427, agnieszka.szczukocka-zych@wum.edu.pl
About this study
It is a randomized, single-center, controlled trial to evaluate the effectiveness of oral immunotherapy with cashew protein compared with standard treatment (elimination diet) in pediatric patients with cashew allergy.
Read the detailed description
According to Polish data, in the population of children suspected of food allergy, cashew was the third nut found to be allergic, after peanut and hazelnut. Allergic reactions to nuts can be severe and life-threatening, making it challenging to avoid hidden sources of the allergen.
An effective and safe alternative to allergen avoidance strategies may be the use of oral specific immunotherapy.
In this study 39 children, aged 4 to 17 years with a diagnosis of IgE-dependent allergy to cashew, confirmed by an open oral provocation test (OFC; the first provocation before starting oral desensitization), will be randomly (2:1) assigned to two groups. The first group will be desensitized with a maintenance dose - 1200mg of cashew protein, while the second group - the control group - will be offered standard management - avoidance of cashew consumption.
Patients in the control group will be offered immunotherapy at the end of the study if its effectiveness is confirmed.
The desensitization procedure was planned in accordance with the guidelines for immunotherapy in food allergy of the European Academy of Allergology and Clinical Immunology.
The source of cashew protein is flour. The first dose of immunotherapy is given to patients in the intervention group in the hospital ward. The size of the initial dose depends on the symptom-triggering dose during the initial oral food provocation with cashew protein.
Every 2 weeks in the hospital setting, another higher dose of cashew protein will be given to the child. The requirement for increasing the dose of cashew is to achieve full tolerance of the previous dose. The maximum duration of this phase is 60 weeks.
After the maximum dose is tolerated, desensitization will continue for 12 weeks - the maintenance phase of desensitization.
The maintenance dose is 1200mg of cashew protein. The duration of the maintenance phase is 12 weeks (+/-3 weeks). After 12 weeks +/-3 weeks of maintenance dose, OFC and cashew protein tolerance assessment will be performed. Confirmation of complete cashew tolerance is the tolerance of a dose of 4043mg of cashew protein. Primary outcomes include the proportion of participants tolerating a single dose of 4043mg cashew protein during the final oral food challenge. Secondary outcomes assess adverse events, changes in immunological parameters, and the maximum tolerated doses of cashew protein in each group.
- Conditions
- Food Allergy
- Being tested
- Cashew immunotherapy
- Keywords
- cashew, food allergy, immunotherapy, children
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cashew immunotherapyCombination product
Following the building-up phase (up to 60 weeks), patients will receive a daily low dose of cashew flour (1200 mg cashew protein) mixed with well-tolerated fruit mousse for 3 months (12 +/- 3 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Cashew Immunotherapy | Experimental | Children with cashew allergy receiving OIT (OIT-oral immunotherapy). Receives: Combination Product: Cashew immunotherapy |
| Cashew avoidance | No intervention | Children with cashew allergy not receiving OIT (OIT-oral immunotherapy). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cashew full tolerance
Percentage of children tolerating a single dose of 4g of cashew protein after 12 weeks of immunotherapy at a maintenance dose.
Measured: Up to 60 weeks of OIT (oral immunotherapy)
Secondary outcomes (8)
Cashew partial tolerance
Percentage of children with partial tolerance, defined as an increase in the tolerated dose by at least 10-fold and tolerance of at least 1.2g of cashew protein but less than 4g of cashew protein at the end of 12 weeks of cashew protein immunotherapy at the maintenance dose or after 60 weeks of immunotherapy
Measured: Up to 60 weeks of OIT (oral immunotherapy)
OIT safety
Number and type of side effects during oral desensitization with cashew protein, divided into mild, moderate and severe.
Measured: Up to 60 weeks of OIT (oral immunotherapy)
Wheal diameter in skin prick tests
Difference in wheal diameter in skin prick tests between groups before and after completion of 12 weeks of cashew protein immunotherapy at the maintenance dose or after 60 weeks of immunotherapy.
Measured: Up to 60 weeks of OIT (oral immunotherapy)
SIgE (specific immunoglobulin E) (kUA/l) levels
Difference in sIgE (specific immunoglobulin E) (kUA/l) levels against cashew, walnut, pistachio, peanut, hazelnut and almond allergens evaluated between groups 12 weeks of immunotherapy at maintenance dose or after 60 weeks of immunotherapy.
Measured: Up to 60 weeks of OIT (oral immunotherapy)
Basophil activation test (BAT)
Difference in BAT test values between groups before and after 12 weeks of immunotherapy at maintenance dose or after 60 weeks of immunotherapy
Measured: Up to 60 weeks of OIT (oral immunotherapy)
Quality of life- FAQLQ (Food Allergy Quality of Life Questionnaire)
Assessment of quality of life before and after desensitization (impact on families' lives) using FAQLQ. In children up to 12 years old we use FAQLQ-PF (Parent Form) and FAQLQ-CF (Child Form) in children 8-12 years old. For children 13-17 years old we use FAQLQ-TF (Teenager Form).
These questionnaires are under validation in Polish and will be used if validation is completed.
The FAQLQ-PF consists of 30 questions divided into three domains: Emotional Impact, Food Anxiety, and Social and Dietary Restrictions. Parents of children aged 4-6 years old answer 26 questions, and parents of children aged 7-12 years old answer all 30 questions. The FAIM (Food Allergy Independence Measure) consists of four questions and assesses parents expectations of their child's food allergy outcomes.
FAQLQ- CF consist of 30 questions. FAQLQ- TF consist of 28 questions. Every question in all questionaires except FAIM part is assessed in 7 points scale, the higher value the worse outcome.
Measured: Up to 60 weeks of OIT (oral immunotherapy)
Air condensate
Evaluation of pro-inflammatory cytokine levels in exhaled air condensate
Measured: Up to 60 weeks of OIT (oral immunotherapy)
IgG4 (immunoglobulin IgG4) (mgA/l) levels
Difference in sIgG4 (immunoglobulin IgG4) (mgA/l) levels against cashew, walnut, pistachio, peanut, hazelnut and almond allergens evaluated between groups 12 weeks of immunotherapy at maintenance dose or after 60 weeks of immunotherapy.
Measured: Up to 60 weeks of OIT (oral immunotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start28 Mar 2024
- Primary completion21 Apr 2026 (estimated)
- Study completion21 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnieszka Szczukocka-Zych, MD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06328504
- Sponsor's protocol ID
- Cashew Protocol
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pajno GB, Fernandez-Rivas M, Arasi S, Roberts G, Akdis CA, Alvaro-Lozano M, Beyer K, Bindslev-Jensen C, Burks W, Ebisawa M, Eigenmann P, Knol E, Nadeau KC, Poulsen LK, van Ree R, Santos AF, du Toit G, Dhami S, Nurmatov U, Boloh Y, Makela M, O'Mahony L, Papadopoulos N, Sackesen C, Agache I, Angier E, Halken S, Jutel M, Lau S, Pfaar O, Ryan D, Sturm G, Varga EM, van Wijk RG, Sheikh A, Muraro A; EAACI Allergen Immunotherapy Guidelines Group. EAACI Guidelines on allergen immunotherapy: IgE-mediated food allergy. Allergy. 2018 Apr;73(4):799-815. doi: 10.1111/all.13319. Epub 2017 Dec 5.
PubMed 29205393Bognanni A, Chu DK, Firmino RT, Arasi S, Waffenschmidt S, Agarwal A, Dziechciarz P, Horvath A, Jebai R, Mihara H, Roldan Y, Said M, Shamir R, Bozzola M, Bahna S, Fiocchi A, Waserman S, Schunemann HJ, Brozek JL; WAO DRACMA Guideline Group. World Allergy Organization (WAO) Diagnosis and Rationale for Action against Cow's Milk Allergy (DRACMA) guideline update - XIII - Oral immunotherapy for CMA - Systematic review. World Allergy Organ J. 2022 Sep 8;15(9):100682. doi: 10.1016/j.waojou.2022.100682. eCollection 2022 Sep.
PubMed 36185550de Silva D, Rodriguez Del Rio P, de Jong NW, Khaleva E, Singh C, Nowak-Wegrzyn A, Muraro A, Begin P, Pajno G, Fiocchi A, Sanchez A, Jones C, Nilsson C, Bindslev-Jensen C, Wong G, Sampson H, Beyer K, Marchisotto MJ, Fernandez Rivas M, Meyer R, Lau S, Nurmatov U, Roberts G; GA2LEN Food Allergy Guidelines Group. Allergen immunotherapy and/or biologicals for IgE-mediated food allergy: A systematic review and meta-analysis. Allergy. 2022 Jun;77(6):1852-1862. doi: 10.1111/all.15211. Epub 2022 Jan 19.
PubMed 35001400Sampson HA, Gerth van Wijk R, Bindslev-Jensen C, Sicherer S, Teuber SS, Burks AW, Dubois AE, Beyer K, Eigenmann PA, Spergel JM, Werfel T, Chinchilli VM. Standardizing double-blind, placebo-controlled oral food challenges: American Academy of Allergy, Asthma & Immunology-European Academy of Allergy and Clinical Immunology PRACTALL consensus report. J Allergy Clin Immunol. 2012 Dec;130(6):1260-74. doi: 10.1016/j.jaci.2012.10.017. No abstract available.
PubMed 23195525Bollinger ME, Dahlquist LM, Mudd K, Sonntag C, Dillinger L, McKenna K. The impact of food allergy on the daily activities of children and their families. Ann Allergy Asthma Immunol. 2006 Mar;96(3):415-21. doi: 10.1016/S1081-1206(10)60908-8.
PubMed 16597075Cox LS, Sanchez-Borges M, Lockey RF. World Allergy Organization Systemic Allergic Reaction Grading System: Is a Modification Needed? J Allergy Clin Immunol Pract. 2017 Jan-Feb;5(1):58-62.e5. doi: 10.1016/j.jaip.2016.11.009.
PubMed 28065342Anagnostou A. Food immunotherapy: current status and future needs. Expert Rev Clin Immunol. 2023 Jun;19(6):561-563. doi: 10.1080/1744666X.2023.2201438. Epub 2023 Apr 11. No abstract available.
PubMed 37038747Koplin JJ, Wake M, Dharmage SC, Matheson M, Tang ML, Gurrin LC, Dwyer T, Peters RL, Prescott S, Ponsonby AL, Lowe AJ, Allen KJ; HealthNuts study group. Cohort Profile: The HealthNuts Study: Population prevalence and environmental/genetic predictors of food allergy. Int J Epidemiol. 2015 Aug;44(4):1161-71. doi: 10.1093/ije/dyu261. Epub 2015 Jan 21.
PubMed 25613427Brough HA, Caubet JC, Mazon A, Haddad D, Bergmann MM, Wassenberg J, Panetta V, Gourgey R, Radulovic S, Nieto M, Santos AF, Nieto A, Lack G, Eigenmann PA. Defining challenge-proven coexistent nut and sesame seed allergy: A prospective multicenter European study. J Allergy Clin Immunol. 2020 Apr;145(4):1231-1239. doi: 10.1016/j.jaci.2019.09.036. Epub 2019 Dec 20.
PubMed 31866098Elizur A, Appel MY, Nachshon L, Levy MB, Epstein-Rigbi N, Koren Y, Holmqvist M, Porsch H, Lidholm J, Goldberg MR. Cashew oral immunotherapy for desensitizing cashew-pistachio allergy (NUT CRACKER study). Allergy. 2022 Jun;77(6):1863-1872. doi: 10.1111/all.15212. Epub 2022 Jan 15.
PubMed 35000223Chojnowska-Wojtowicz M, Lyzwa K, Zielinska J, Zagorska W, Grzela K. Prevalence of nut allergen sensitization among children in central Poland. Postepy Dermatol Alergol. 2023 Feb;40(1):40-46. doi: 10.5114/ada.2022.124730. Epub 2023 Feb 27.
PubMed 36909898Lyzwa K, Chojnowska-Wojtowicz M, Zielinska J, Zagorska W, Kulus M, Grzela K. Sensitization to nut allergens in children with food allergy and other atopic diseases - just a coexistence? Postepy Dermatol Alergol. 2023 Jun;40(3):402-410. doi: 10.5114/ada.2023.128991. Epub 2023 Jul 16.
PubMed 37545822Szczukocka A, Pietrzyk-Kozinska M, Zielinska J, Krupa-Laska A, Krejner-Bienias A, Kulus M, Grzela K. Efficacy of cashew nut protein immunotherapy: protocol for a single-centre randomised controlled trial in a Polish paediatric population. BMJ Open. 2025 Jul 1;15(7):e101139. doi: 10.1136/bmjopen-2025-101139.
PubMed 40592755
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cashew Nut Protein Immunotherapy
- ClinicalTrials.gov ID
- NCT06328504
- Acronym / sponsor ID
- Cashew Protocol
- Conditions
- Food Allergy
- Keywords
- cashew, food allergy, immunotherapy, children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 21 Apr 2026 (estimated)
- Study completion
- 21 Apr 2027 (estimated)
- First posted
- 25 Mar 2024 (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.
It is a randomized, single-center, controlled trial to evaluate the effectiveness of oral immunotherapy with cashew protein compared with standard treatment (elimination diet) in pediatric patients with cashew allergy.
Detailed description
According to Polish data, in the population of children suspected of food allergy, cashew was the third nut found to be allergic, after peanut and hazelnut. Allergic reactions to nuts can be severe and life-threatening, making it challenging to avoid hidden sources of the allergen.
An effective and safe alternative to allergen avoidance strategies may be the use of oral specific immunotherapy.
In this study 39 children, aged 4 to 17 years with a diagnosis of IgE-dependent allergy to cashew, confirmed by an open oral provocation test (OFC; the first provocation before starting oral desensitization), will be randomly (2:1) assigned to two groups. The first group will be desensitized with a maintenance dose - 1200mg of cashew protein, while the second group - the control group - will be offered standard management - avoidance of cashew consumption.
Patients in the control group will be offered immunotherapy at the end of the study if its effectiveness is confirmed.
The desensitization procedure was planned in accordance with the guidelines for immunotherapy in food allergy of the European Academy of Allergology and Clinical Immunology.
The source of cashew protein is flour. The first dose of immunotherapy is given to patients in the intervention group in the hospital ward. The size of the initial dose depends on the symptom-triggering dose during the initial oral food provocation with cashew protein.
Every 2 weeks in the hospital setting, another higher dose of cashew protein will be given to the child. The requirement for increasing the dose of cashew is to achieve full tolerance of the previous dose. The maximum duration of this phase is 60 weeks.
After the maximum dose is tolerated, desensitization will continue for 12 weeks - the maintenance phase of desensitization.
The maintenance dose is 1200mg of cashew protein. The duration of the maintenance phase is 12 weeks (+/-3 weeks). After 12 weeks +/-3 weeks of maintenance dose, OFC and cashew protein tolerance assessment will be performed. Confirmation of complete cashew tolerance is the tolerance of a dose of 4043mg of cashew protein. Primary outcomes include the proportion of participants tolerating a single dose of 4043mg cashew protein during the final oral food challenge. Secondary outcomes assess adverse events, changes in immunological parameters, and the maximum tolerated doses of cashew protein in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cashew Immunotherapy | Experimental | Combination Product: Cashew immunotherapyChildren with cashew allergy receiving OIT (OIT-oral immunotherapy). |
| Cashew avoidance | No intervention | –Children with cashew allergy not receiving OIT (OIT-oral immunotherapy). |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- age between 4 and 17 years,
- IgE (immunoglobulin E) -mediated cashew allergy confirmed with positive skin prick tests with cashew allergens (diameter of the wheal greater than 3mm) and/or specific IgE (immunoglobulin E) level greater than 0.35-kilo units of Allergen per liter (kUA/l),
- allergic reaction to cashew protein during oral food challenge (OFC),
- Signed Informed Consent by parent/legal guardian and patient aged >16 years old,
- Patient's and caregivers' cooperation with the researcher.
Key exclusion criteria (17 listed)
- no confirmed allergy to cashew,
- negative provocation test with cashew,
- severe asthma,
- mild/moderate asthma poorly controlled: FEV1 (forced expiratory volume at one second) <80% (less than 5 perc), FEV1/FVC (forced expiratory volume at one second/forced vital capacity) <75% (less than 5 perc), hospitalization for asthma exacerbation in the past 12 months,
- oral/sublingual/subcutaneous immunotherapy to other allergens during the study,
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 |
|---|---|---|
| Cashew immunotherapyFollowing the building-up phase (up to 60 weeks), patients will receive a daily low dose of cashew flour (1200 mg cashew protein) mixed with well-tolerated fruit mousse for 3 months (12 +/- 3 weeks). | Combination product | Cashew Immunotherapy |
Primary outcome
Cashew full tolerance
Time frame: Up to 60 weeks of OIT (oral immunotherapy)
Percentage of children tolerating a single dose of 4g of cashew protein after 12 weeks of immunotherapy at a maintenance dose.
8 secondary outcomes
Cashew partial tolerance
Time frame: Up to 60 weeks of OIT (oral immunotherapy)
OIT safety
Time frame: Up to 60 weeks of OIT (oral immunotherapy)
Wheal diameter in skin prick tests
Time frame: Up to 60 weeks of OIT (oral immunotherapy)
SIgE (specific immunoglobulin E) (kUA/l) levels
Time frame: Up to 60 weeks of OIT (oral immunotherapy)
Basophil activation test (BAT)
Time frame: Up to 60 weeks of OIT (oral immunotherapy)
Quality of life- FAQLQ (Food Allergy Quality of Life Questionnaire)
Time frame: Up to 60 weeks of OIT (oral immunotherapy)
Air condensate
Time frame: Up to 60 weeks of OIT (oral immunotherapy)
IgG4 (immunoglobulin IgG4) (mgA/l) levels
Time frame: Up to 60 weeks of OIT (oral immunotherapy)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Background: PubMed 29205393Pajno GB, Fernandez-Rivas M, Arasi S, Roberts G, Akdis CA, Alvaro-Lozano M, Beyer K, Bindslev-Jensen C, Burks W, Ebisawa M, Eigenmann P, Knol E, Nadeau KC, Poulsen LK, van Ree R, Santos AF, du Toit G, Dhami S, Nurmatov U, Boloh Y, Makela M, O'Mahony L, Papadopoulos N, Sackesen C, Agache I, Angier E, Halken S, Jutel M, Lau S, Pfaar O, Ryan D, Sturm G, Varga EM, van Wijk RG, Sheikh A, Muraro A; EAACI Allergen Immunotherapy Guidelines Group. EAACI Guidelines on allergen immunotherapy: IgE-mediated food allergy. Allergy. 2018 Apr;73(4):799-815. doi: 10.1111/all.13319. Epub 2017 Dec 5.
- Background: PubMed 36185550Bognanni A, Chu DK, Firmino RT, Arasi S, Waffenschmidt S, Agarwal A, Dziechciarz P, Horvath A, Jebai R, Mihara H, Roldan Y, Said M, Shamir R, Bozzola M, Bahna S, Fiocchi A, Waserman S, Schunemann HJ, Brozek JL; WAO DRACMA Guideline Group. World Allergy Organization (WAO) Diagnosis and Rationale for Action against Cow's Milk Allergy (DRACMA) guideline update - XIII - Oral immunotherapy for CMA - Systematic review. World Allergy Organ J. 2022 Sep 8;15(9):100682. doi: 10.1016/j.waojou.2022.100682. eCollection 2022 Sep.
- Background: PubMed 35001400de Silva D, Rodriguez Del Rio P, de Jong NW, Khaleva E, Singh C, Nowak-Wegrzyn A, Muraro A, Begin P, Pajno G, Fiocchi A, Sanchez A, Jones C, Nilsson C, Bindslev-Jensen C, Wong G, Sampson H, Beyer K, Marchisotto MJ, Fernandez Rivas M, Meyer R, Lau S, Nurmatov U, Roberts G; GA2LEN Food Allergy Guidelines Group. Allergen immunotherapy and/or biologicals for IgE-mediated food allergy: A systematic review and meta-analysis. Allergy. 2022 Jun;77(6):1852-1862. doi: 10.1111/all.15211. Epub 2022 Jan 19.
- Background: PubMed 23195525Sampson HA, Gerth van Wijk R, Bindslev-Jensen C, Sicherer S, Teuber SS, Burks AW, Dubois AE, Beyer K, Eigenmann PA, Spergel JM, Werfel T, Chinchilli VM. Standardizing double-blind, placebo-controlled oral food challenges: American Academy of Allergy, Asthma & Immunology-European Academy of Allergy and Clinical Immunology PRACTALL consensus report. J Allergy Clin Immunol. 2012 Dec;130(6):1260-74. doi: 10.1016/j.jaci.2012.10.017. No abstract available.
- Background: PubMed 16597075Bollinger ME, Dahlquist LM, Mudd K, Sonntag C, Dillinger L, McKenna K. The impact of food allergy on the daily activities of children and their families. Ann Allergy Asthma Immunol. 2006 Mar;96(3):415-21. doi: 10.1016/S1081-1206(10)60908-8.
- Background: PubMed 28065342Cox LS, Sanchez-Borges M, Lockey RF. World Allergy Organization Systemic Allergic Reaction Grading System: Is a Modification Needed? J Allergy Clin Immunol Pract. 2017 Jan-Feb;5(1):58-62.e5. doi: 10.1016/j.jaip.2016.11.009.
- Background: PubMed 37038747Anagnostou A. Food immunotherapy: current status and future needs. Expert Rev Clin Immunol. 2023 Jun;19(6):561-563. doi: 10.1080/1744666X.2023.2201438. Epub 2023 Apr 11. No abstract available.
- Background: PubMed 25613427Koplin JJ, Wake M, Dharmage SC, Matheson M, Tang ML, Gurrin LC, Dwyer T, Peters RL, Prescott S, Ponsonby AL, Lowe AJ, Allen KJ; HealthNuts study group. Cohort Profile: The HealthNuts Study: Population prevalence and environmental/genetic predictors of food allergy. Int J Epidemiol. 2015 Aug;44(4):1161-71. doi: 10.1093/ije/dyu261. Epub 2015 Jan 21.
- Background: PubMed 31866098Brough HA, Caubet JC, Mazon A, Haddad D, Bergmann MM, Wassenberg J, Panetta V, Gourgey R, Radulovic S, Nieto M, Santos AF, Nieto A, Lack G, Eigenmann PA. Defining challenge-proven coexistent nut and sesame seed allergy: A prospective multicenter European study. J Allergy Clin Immunol. 2020 Apr;145(4):1231-1239. doi: 10.1016/j.jaci.2019.09.036. Epub 2019 Dec 20.
- Background: PubMed 35000223Elizur A, Appel MY, Nachshon L, Levy MB, Epstein-Rigbi N, Koren Y, Holmqvist M, Porsch H, Lidholm J, Goldberg MR. Cashew oral immunotherapy for desensitizing cashew-pistachio allergy (NUT CRACKER study). Allergy. 2022 Jun;77(6):1863-1872. doi: 10.1111/all.15212. Epub 2022 Jan 15.
- Background: PubMed 36909898Chojnowska-Wojtowicz M, Lyzwa K, Zielinska J, Zagorska W, Grzela K. Prevalence of nut allergen sensitization among children in central Poland. Postepy Dermatol Alergol. 2023 Feb;40(1):40-46. doi: 10.5114/ada.2022.124730. Epub 2023 Feb 27.
- Background: PubMed 37545822Lyzwa K, Chojnowska-Wojtowicz M, Zielinska J, Zagorska W, Kulus M, Grzela K. Sensitization to nut allergens in children with food allergy and other atopic diseases - just a coexistence? Postepy Dermatol Alergol. 2023 Jun;40(3):402-410. doi: 10.5114/ada.2023.128991. Epub 2023 Jul 16.
- 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.
Agnieszka Szczukocka-Zych, MD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cashew immunotherapy in people with Food Allergy, run by Medical University of Warsaw at 1 site in Poland.
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 5 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 30 Jan 2025. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katarzyna Grzela, PhD, MD (+48223179431, katarzyna.grzela@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cashew full tolerance (time frame: Up to 60 weeks of OIT (oral immunotherapy)). 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 NCT06328504, which also lists 13 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 30 Jan 2025.