Multi-Food Oral Immunotherapy for Peanut and Tree Nuts
2026년 8월 11일 업데이트: Medical University of Warsaw
An Open-Label, Multicenter, Randomized Clinical Trial Evaluating the Efficacy and Safety of Oral Multi-Food Immunotherapy With Peanut and Tree Nuts Protein Mixtures
This study aims to evaluate the efficacy and safety of multi-food oral immunotherapy (multi-OIT) using peanut and tree nuts proteins in children with confirmed food allergy to at least two allergens.
Participants will be randomized in a 2:1 ratio to receive either multi-OIT or standard management consisting of an elimination diet.
The primary objective is to evaluate immunotherapy efficacy defined as achieving tolerance to a cumulative dose of 4444 mg of protein during an oral food challenge (OFC-2) for at least one allergen that elicited a reaction during baseline challenge (OFC-1), compared with the control group.
Secondary outcomes include the proportion of participants tolerating multiple allergens at the target cumulative dose; the incidence, type, and severity of adverse events classified according to the World Allergy Organization (WAO) grading system; changes in immunological parameters, including allergen-specific IgE and IgG4 levels; changes in skin prick test responses; changes in the quality of life of patients and their families.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
상세 설명
This is an interventional, open-label, multicenter, randomized clinical trial enrolling 39 children aged 1-12 years with confirmed allergy to at least two of the following allergens: peanut, cashew, walnut, hazelnut and almond.
Participants will be randomized in a 2:1 ratio to either the experimental group receiving multi-food oral immunotherapy (multi-OIT) or the control group receiving standard of care consisting of an elimination diet and rescue medications. Multi-OIT will be administered using a standardized mixture of peanut and tree nuts proteins, with a dose-escalation phase followed by a maintenance phase targeting 300 mg of protein per allergen per day. Treatment duration will be approximately 18 months.
All participants will undergo oral food challenges at baseline (OFC-1) and at the end of the study (OFC-2). The primary efficacy endpoint is defined as the proportion of participants achieving tolerance to a cumulative dose of 4444 mg of protein during OFC-2 for at least one allergen that elicited a reaction during OFC-1, compared with the control group. Safety will be monitored throughout the study based on adverse events recorded in symptom diaries and classified according to established grading systems.
Secondary outcomes include the proportion of participants tolerating multiple allergens at the target cumulative dose, the frequency and severity of adverse events classified according to the World Allergy Organization (WAO) grading system, changes in immunological parameters (including allergen-specific IgE and IgG4), skin prick test responses and quality of life of patients and their families.
Participants in the control group will be offered the option to receive immunotherapy after completion of the study.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
39
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Katarzyna Grzela, PhD, MD
- 전화번호: +48 22 3179417
- 이메일: katarzyna.grzela@wum.edu.pl
연구 장소
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, 폴란드, 60-572
- Department of Pediatric Pulmonology, Allergology and Clinical Immunology, Institute of Pediatrics, Karol Jonscher Clinical Hospital, Poznań University of Medical Sciences
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연락하다:
- Irena Wojsyk-Banaszak, MD, PhD
- 전화번호: +48618491313
- 이메일: sekretpulmo@skp.ump.edu.pl
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, 폴란드, 30-663
- Department of Pediatrics, Children's Diseases Clinic, Jagiellonian University Medical Colleg, Division of Pulmonology, Allergology and Dermatology, University Children's Hospital in Kraków
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연락하다:
- Ewa Cichocka-Jarosz, MD, PhD
- 전화번호: +48 12 333 94 77
- 이메일: mijarosz@cyf-kr.edu.pl
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Masovian Voivodeship
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Dziekanów Leśny, Masovian Voivodeship, 폴란드, 05-092
- Allergy Unit, Department of Pulmonary Diseases, Children's Hospital in Dziekanów Leśny
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연락하다:
- Wioletta Zagórska, MD, PhD
- 전화번호: +48 22 765 74 02
- 이메일: wioletta.zagorska@szpitaldziekanow.pl
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Warsaw, Masovian Voivodeship, 폴란드, 02-091
- Department of Paediatric Pulmonology and Allergology, Medical University of Warsaw
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연락하다:
- Katarzyna Grzela, MD, PhD
- 전화번호: +48 22 3179417
- 이메일: katarzyna.grzela@wum.edu.pl
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Age 1-12 years;
- Confirmed allergy to at least two allergens included in the protocol, i.e., peanut and/or tree nuts: cashew, walnut, hazelnut, and almond;
- Positive skin prick test (SPT) (wheal diameter ≥ 3 mm) and/or specific IgE (sIgE) level > 0.35 kUA/L for at least two of the analyzed allergens;
- Positive OFC-1 (oral food challenge) of grade I-IV according to the WAO classification for at least two allergens, with a positive reaction occurring after administration of a dose ≥ 3 mg and ≤ 3000 mg of allergen protein;
- Participants may be enrolled based on the abbreviated procedure as outlined in the study description;
- Written informed consent obtained from a legal guardian, and, where applicable, assent from the child in accordance with their age and level of maturity;
- Good prognosis for compliance and cooperation of the patient and their caregivers.
Exclusion Criteria:
- Allergic reaction at the lowest challenge dose of 1 mg of allergen protein for any allergen, or no allergic reaction after administration of the maximum dose of 3000 mg of allergen protein for at least four of the analyzed allergens;
- History of anaphylaxis with a grade V reaction according to the WAO classification, either during an oral food challenge or in the patient's medical history;
- Severe asthma;
- Poorly controlled asthma according to GINA 2025 (lack of symptom control and/or ≥2 exacerbations requiring systemic glucocorticoids or ≥1 exacerbation requiring hospitalization within the last 12 months), or in children able to perform spirometry: FEV1 < -1.64 Z-score and/or FEV1/FVC < -1.64 Z-score;
- Eosinophilic gastrointestinal disease;
- Other chronic diseases requiring ongoing treatment which, in the investigator's opinion, may increase the risk associated with study participation or interfere with the interpretation of results, including severe cardiac disease, epilepsy, metabolic disorders, or diabetes;
- Previous immunotherapy with food allergens;
- Concurrent immunotherapy with aeroallergens;
- Treatment with biologic agents, beta-blockers, ACE inhibitors, or calcium channel blockers;
- Oral corticosteroid therapy meeting any of the following criteria: daily treatment for >1 month within the last 12 months; at least two courses lasting ≥7 days within the last 12 months; one course lasting ≥7 days within the last 3 months;
- Lack of consent to participate in the study or insufficient cooperation of the patient and/or caregivers. In such cases, patients will receive standard medical care, including allergen avoidance and provision of emergency medication.
Well-controlled asthma, allergic rhinitis, and atopic dermatitis are not exclusion criteria.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Multi-Food Oral Immunotherapy (Multi-OIT)
Participants will receive multi-food oral immunotherapy (multi-OIT) using a standardized mixture of peanut and tree nuts proteins (cashew, walnut, hazelnut, and almond).
Treatment includes a dose-escalation phase (1-300 mg protein per allergen) followed by a maintenance phase for 12 months (+/- 3 months) with a target daily dose of 300 mg of protein per allergen.
Dose increases will be performed under medical supervision, and daily dosing will be continued at home.
The total treatment duration is approximately 18 months.
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Multi-food oral immunotherapy using a standardized mixture of peanut and tree nuts proteins (cashew, walnut, hazelnut, and almond), administered in a dose-escalation phase followed by a maintenance phase with a target daily dose of 300 mg of protein per allergen.
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활성 비교기: Standard of Care (Elimination Diet)
Participants will continue standard management consisting of strict elimination of peanut and tree nuts from the diet and use of rescue medications, including epinephrine, in case of accidental exposure.
Participants will be monitored according to the study schedule and will undergo follow-up assessments comparable to the experimental group.
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Standard management consisting of strict dietary avoidance of peanut and tree nuts, along with the use of rescue medications, including epinephrine, in the event of accidental allergen exposure.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Immunotherapy Efficacy
기간: Up to 21 months after starting oral immunotherapy
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Evaluation of immunotherapy efficacy defined as achieving tolerance to a cumulative dose of 4444 mg of protein during OFC-2 for at least one allergen that elicited a reaction during OFC-1, compared with the control group.
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Up to 21 months after starting oral immunotherapy
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of Participants Tolerating at least 2, 3, 4 or 5 Allergens at a Cumulative Dose of 4444 mg During OFC-2
기간: Up to 21 months after starting oral immunotherapy
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Proportion of participants who tolerate a cumulative dose of 4444 mg of protein for at least 2, 3, 4, or 5 allergens during OFC-2 (post-treatment oral food challenge).
Tolerance is defined as consumption of the full cumulative dose without dose-limiting allergic symptoms.
The outcome will be summarized as the proportion of participants meeting each threshold and compared between study groups.
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Up to 21 months after starting oral immunotherapy
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Change in Maximum Tolerated Allergen Dose from OFC-1 to OFC-2
기간: Up to 21 months after starting oral immunotherapy
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Change in the maximum tolerated dose (mg of protein) of allergens during oral food challenge from OFC-1 (baseline) to OFC-2 (post-treatment).
The maximum tolerated dose is defined as the highest cumulative dose ingested without dose-limiting allergic symptoms.
Changes will be analyzed within and between study groups.
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Up to 21 months after starting oral immunotherapy
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Incidence, Type and Severity of Adverse Events During Immunotherapy Compared with Control (WAO Grading)
기간: Up to 21 months after starting oral immunotherapy
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Number, type, and severity of adverse events during immunotherapy compared with the control group, assessed based on symptom diaries and classified by severity according to the WAO scale.
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Up to 21 months after starting oral immunotherapy
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Change in Skin Prick Test (SPT) Wheal Diameter for Peanut and Tree Nut Allergens from Baseline to Final Assessment
기간: Up to 21 months after starting oral immunotherapy
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Measurement of change in wheal diameter (mm) for peanut and tree nut allergens as assessed by skin prick testing (SPT) between baseline (OFC-1) and final assessment (OFC-2).
Wheal size will be recorded as the mean diameter and compared within and between study groups.
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Up to 21 months after starting oral immunotherapy
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Change from Baseline in Allergen-Specific IgE (sIgE) and IgG4 Levels
기간: Up to 21 months after starting oral immunotherapy
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Change in serum concentrations of sIgE and IgG4 from baseline to post-treatment assessment.
Measurements will be performed using standardized immunoassays and analyzed as continuous variables to evaluate immunologic response to therapy.
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Up to 21 months after starting oral immunotherapy
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Change in Food Allergy-Related Quality of Life (FAQLQ)
기간: Up to 21 months after starting oral immunotherapy
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Change in quality of life of patients and their families from baseline to post-treatment assessment, as measured using the Food Allergy Quality of Life Questionnaire (FAQLQ).
Scores will be analysed as continuous variables to assess the impact of treatment on daily functioning and well-being.
Scores range from 1 to 7, with higher scores indicating worse quality of life.
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Up to 21 months after starting oral immunotherapy
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Brough 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.
- Andorf S, Manohar M, Dominguez T, Block W, Tupa D, Kshirsagar RA, Sampath V, Chinthrajah RS, Nadeau KC. Feasibility of sustained response through long-term dosing in food allergy immunotherapy. Allergy Asthma Clin Immunol. 2017 Dec 21;13:52. doi: 10.1186/s13223-017-0224-7. eCollection 2017.
- Chojnowska-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.
- Lodge CJ, Waidyatillake N, Peters RL, Netting M, Dai X, Burgess J, Hornung CJ, Perrett KP, Tang MLK, Koplin JJ, Dharmage SC. Efficacy and safety of oral immunotherapy for peanut, cow's milk, and hen's egg allergy: A systematic review of randomized controlled trials. Clin Transl Allergy. 2023 Jul;13(7):e12268. doi: 10.1002/clt2.12268.
- Pasioti M, Xepapadaki P, Mathioudakis AG, Lakoumentas J, Efstathiou E, Papadopoulos NG. Current options in the management of tree nut allergy: A systematic review and narrative synthesis. Pediatr Allergy Immunol. 2024 May;35(5):e14132. doi: 10.1111/pai.14132.
- Upton JEM, Toscano-Rivero D, Ke D, Berenjy A, Lejtenyi D, Beaudette L, Yin X, Li CH, Duan LY, Cohen CG, Kim V, Marzouk S, Grunebaum E, McCusker CT, Mazer B, Eiwegger T, Ben-Shoshan M. Peanut Oral Immunotherapy Using 30 and 300 mg Maintenance Doses. J Allergy Clin Immunol Pract. 2026 Jan;14(1):223-232.e7. doi: 10.1016/j.jaip.2025.10.007. Epub 2025 Oct 16.
- Upton JEM, Li CH, Berenjy A, Galper A, Yin X, Celik A, Duan L, Wong S, Ditlof CM, San Diego KE, Hoang JA, Ben-Shoshan M, Kothari A, Hung L, Monteiro M, Phue WH, Moraes TJ, Eiwegger T. Safety and Efficacy of Very Low-Dose Multi-Nut Oral Immunotherapy in Children. Clin Transl Allergy. 2025 Dec;15(12):e70125. doi: 10.1002/clt2.70125.
- Turner PJ, Ansotegui IJ, Campbell DE, Cardona V, Carr S, Custovic A, Durham S, Ebisawa M, Geller M, Gonzalez-Estrada A, Greenberger PA, Hossny E, Irani C, Leung ASY, Levin ME, Muraro A, Oppenheimer JJ, Ortega Martell JA, Pouessel G, Rial MJ, Senna G, Tanno LK, Wallace DV, Worm M, Morais-Almeida M; WAO Anaphylaxis Committee and WAO Allergen Immunotherapy Committee. Updated grading system for systemic allergic reactions: Joint Statement of the World Allergy Organization Anaphylaxis Committee and Allergen Immunotherapy Committee. World Allergy Organ J. 2024 Feb 10;17(3):100876. doi: 10.1016/j.waojou.2024.100876. eCollection 2024 Mar.
- Sampson HA, Arasi S, Bahnson HT, Ballmer-Weber B, Beyer K, Bindslev-Jensen C, Bird JA, Blumchen K, Davis C, Ebisawa M, Nowak-Wegrzyn A, Patel N, Peters RL, Sicherer S, Spergel J, Turner PJ, Yanagida N, Eigenmann PA. AAAAI-EAACI PRACTALL: Standardizing oral food challenges-2024 Update. Pediatr Allergy Immunol. 2024 Nov;35(11):e14276. doi: 10.1111/pai.14276.
- Jones SM, Kim EH, Nadeau KC, Nowak-Wegrzyn A, Wood RA, Sampson HA, Scurlock AM, Chinthrajah S, Wang J, Pesek RD, Sindher SB, Kulis M, Johnson J, Spain K, Babineau DC, Chin H, Laurienzo-Panza J, Yan R, Larson D, Qin T, Whitehouse D, Sever ML, Sanda S, Plaut M, Wheatley LM, Burks AW; Immune Tolerance Network. Efficacy and safety of oral immunotherapy in children aged 1-3 years with peanut allergy (the Immune Tolerance Network IMPACT trial): a randomised placebo-controlled study. Lancet. 2022 Jan 22;399(10322):359-371. doi: 10.1016/S0140-6736(21)02390-4.
- Erdle SC, Cook VE, Cameron SB, Yeung J, Kapur S, McHenry M, Chan ES, Mak R, Rex GA, Wong T, Soller L. Real-World Safety Analysis of Preschool Tree Nut Oral Immunotherapy. J Allergy Clin Immunol Pract. 2023 Apr;11(4):1177-1183. doi: 10.1016/j.jaip.2023.01.031. Epub 2023 Feb 1.
- Huang J, Puglisi LH, Cook KA, Kelso JM, Wangberg H. Safety and Feasibility of Peanut, Tree Nut, and Sesame Oral Immunotherapy in Infants and Toddlers in a Real-World Setting. J Allergy Clin Immunol Pract. 2025 Jan;13(1):185-191.e3. doi: 10.1016/j.jaip.2024.09.025. Epub 2024 Sep 30.
- Begin P, Winterroth LC, Dominguez T, Wilson SP, Bacal L, Mehrotra A, Kausch B, Trela A, Hoyte E, O'Riordan G, Seki S, Blakemore A, Woch M, Hamilton RG, Nadeau KC. Safety and feasibility of oral immunotherapy to multiple allergens for food allergy. Allergy Asthma Clin Immunol. 2014 Jan 15;10(1):1. doi: 10.1186/1710-1492-10-1.
- Nguyen K, Lewis MO, Hanna E, Alfaro MKC, Corrigan K, Buonanno J, Datta R, Brown-Whitehorn T, Spergel JM, Cianferoni A. Safety of Multifood Oral Immunotherapy in Children Aged 1 to 18 Years at an Academic Pediatric Clinic. J Allergy Clin Immunol Pract. 2023 Jun;11(6):1907-1913.e1. doi: 10.1016/j.jaip.2023.03.002. Epub 2023 Mar 10.
- Santos AF, Riggioni C, Agache I, Akdis CA, Akdis M, Alvarez-Perea A, Alvaro-Lozano M, Ballmer-Weber B, Barni S, Beyer K, Bindslev-Jensen C, Brough HA, Buyuktiryaki B, Chu D, Del Giacco S, Dunn-Galvin A, Eberlein B, Ebisawa M, Eigenmann P, Eiwegger T, Feeney M, Fernandez-Rivas M, Fiocchi A, Fisher HR, Fleischer DM, Giovannini M, Gray C, Hoffmann-Sommergruber K, Halken S, O'B Hourihane J, Jones CJ, Jutel M, Knol EF, Konstantinou GN, Lack G, Lau S, Mejias AM, Marchisotto MJ, Meyer R, Mortz CG, Moya B, Muraro A, Nilsson C, de Oliveira LCL, O'Mahony L, Papadopoulos NG, Perrett KP, Peters R, Podesta M, Poulsen LK, Roberts G, Sampson H, Schwarze J, Smith P, Tham E, Untersmayr E, Van Ree R, Venter C, Vickery B, Vlieg-Boerstra B, Werfel T, Worm M, Du Toit G, Skypala I. EAACI guidelines on the management of IgE-mediated food allergy. Allergy. 2025 Jan;80(1):14-36. doi: 10.1111/all.16345. Epub 2024 Oct 30.
- Lyons SA, Clausen M, Knulst AC, Ballmer-Weber BK, Fernandez-Rivas M, Barreales L, Bieli C, Dubakiene R, Fernandez-Perez C, Jedrzejczak-Czechowicz M, Kowalski ML, Kralimarkova T, Kummeling I, Mustakov TB, Papadopoulos NG, Popov TA, Xepapadaki P, Welsing PMJ, Potts J, Mills ENC, van Ree R, Burney PGJ, Le TM. Prevalence of Food Sensitization and Food Allergy in Children Across Europe. J Allergy Clin Immunol Pract. 2020 Sep;8(8):2736-2746.e9. doi: 10.1016/j.jaip.2020.04.020. Epub 2020 Apr 21.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 9월 1일
기본 완료 (추정된)
기본 완료
2031년 9월 1일
연구 완료 (추정된)
연구 완료
2031년 12월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 7월 27일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 8월 11일
처음 게시됨 (실제)
처음 게시됨
2026년 8월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 8월 13일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 11일
마지막으로 확인됨
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- Multifood
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
De-identified individual participant data (IPD) that underlie the results reported in this study will be made available to qualified researchers upon reasonable request. Data requests may be submitted beginning 9 months after publication of the primary study results. Approved data will be accessible for a period of up to 24 months, with potential extensions considered on a case-by-case basis.
Access will be granted to researchers conducting independent scientific research, following review and approval of a detailed research proposal and a corresponding Statistical Analysis Plan (SAP). A Data Sharing Agreement (DSA) must be executed prior to data release.
For additional information or to submit a data access request, please contact: katarzyna.grzela@wum.edu.pl.
IPD 공유 기간
Data requests may be submitted beginning 9 months after publication of the primary study results.
Approved data will be made available for a period of up to 24 months.
Requests for extension beyond this period will be considered on a case-by-case basis.
IPD 공유 액세스 기준
Access to de-identified individual participant data (IPD) may be requested by qualified researchers conducting independent scientific research.
Access will be granted following review and approval of a research proposal and a corresponding Statistical Analysis Plan (SAP), and upon execution of a Data Sharing Agreement (DSA).
For additional information or to submit a request, please contact katarzyna.grzela@wum.edu.pl
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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