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Multi-Food Oral Immunotherapy for Peanut and Tree Nuts

2026年8月11日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

39

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • ポーランド
    • Greater Poland Voivodeship
      • Poznan、Greater Poland Voivodeship、ポーランド、60-572
        • Department of Pediatric Pulmonology, Allergology and Clinical Immunology, Institute of Pediatrics, Karol Jonscher Clinical Hospital, Poznań University of Medical Sciences
        • コンタクト：
    • Lesser Poland Voivodeship
      • Krakow、Lesser Poland Voivodeship、ポーランド、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
        • コンタクト：
    • Masovian Voivodeship
      • Dziekanów Leśny、Masovian Voivodeship、ポーランド、05-092
        • Allergy Unit, Department of Pulmonary Diseases, Children's Hospital in Dziekanów Leśny
        • コンタクト：
      • Warsaw、Masovian Voivodeship、ポーランド、02-091
        • Department of Paediatric Pulmonology and Allergology, Medical University of Warsaw
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
他の：Multi-Food Oral Immunotherapy (Multi-OIT) with Peanut and Tree Nuts Proteins
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.
アクティブコンパレータ：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.
他の：Standard of Care (Elimination Diet)
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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Immunotherapy Efficacy
時間枠：Up to 21 months after starting oral immunotherapy
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.
Up to 21 months after starting oral immunotherapy

二次結果の測定

結果測定
メジャーの説明
時間枠
Proportion of Participants Tolerating at least 2, 3, 4 or 5 Allergens at a Cumulative Dose of 4444 mg During OFC-2
時間枠：Up to 21 months after starting oral immunotherapy
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.
Up to 21 months after starting oral immunotherapy
Change in Maximum Tolerated Allergen Dose from OFC-1 to OFC-2
時間枠：Up to 21 months after starting oral immunotherapy
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.
Up to 21 months after starting oral immunotherapy
Incidence, Type and Severity of Adverse Events During Immunotherapy Compared with Control (WAO Grading)
時間枠：Up to 21 months after starting oral immunotherapy
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.
Up to 21 months after starting oral immunotherapy
Change in Skin Prick Test (SPT) Wheal Diameter for Peanut and Tree Nut Allergens from Baseline to Final Assessment
時間枠：Up to 21 months after starting oral immunotherapy
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.
Up to 21 months after starting oral immunotherapy
Change from Baseline in Allergen-Specific IgE (sIgE) and IgG4 Levels
時間枠：Up to 21 months after starting oral immunotherapy
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.
Up to 21 months after starting oral immunotherapy
Change in Food Allergy-Related Quality of Life (FAQLQ)
時間枠：Up to 21 months after starting oral immunotherapy
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.
Up to 21 months after starting oral immunotherapy

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Medical University of Warsaw

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2031年9月1日

研究の完了 (推定)

2031年12月1日

試験登録日

最初に提出

2026年7月27日

QC基準を満たした最初の提出物

2026年8月11日

最初の投稿 (実際)

2026年8月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月13日

QC基準を満たした最後の更新が送信されました

2026年8月11日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • Multifood

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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 共有アクセス基準

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 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF

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米国FDA規制機器製品の研究

いいえ

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