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Набор скоро начнётся NCT07073404

Omalizumab for Plant-Food Allergy Due to Sensitization to LTP or Profilin

— Наблюдательное Food Allergies

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Omalizumab Injection.
Кому может быть актуально
Состояния в реестре: Food Allergies. Базовые параметры: 14 лет — 55 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Omalizumab for the Monotherapy Treatment of Patients With Allergy to Foods of Plant Origin Due to Sensitization to Lipid Transfer Proteins (LTPs) and Profilin

Обзор

Omalizumab has demonstrated efficacy, increasing the tolerance threshold in patients with multiple food allergies, as well as reducing the risk of severe reactions when used as monotherapy. This favors improving the reactivity profile of patients with food allergy. In our setting, plant allergy caused by sensitization to panallergens such as lipid transfer proteins (LTPs) and profilins entails important limitations for the consumption of a healthy diet due to the extensive dietary restrictions. The main objective of this project is to analyze the efficacy of treatment with omalizumab administered every 2-4/weeks, used in monotherapy in patients with plant allergy due to sensitization to profilin and LTPs and those patients in whom sublingual immunotherapy with Pru p 3 (peach LTP), has not been effective, by performing a before-after study we will evaluate the changes in clinical reactivity to LTP (peach) and profilin (melon) and the changes immunological effect after omalizumab intervention. In addition, we will evaluate the changes in reactivity to at least one food other than peach and melon in the different sensitization profiles.

Вмешательства

  • Препарат Omalizumab Injection
    Treatment with omalizumab in monotherapy for 16 weeks in patients allergic to vegetables due to sensitization to lipid transfer proteins (LTPs) and profilin.

Первичные конечные точки

  • Change in tolerated dose of peach or melon during physician-supervised oral food challenge (PPO) in patients with vegetable allergy due to sensitization to lipid transfer proteins (LTPs) or profilin [Срок оценки: 16 weeks]
Вторичные конечные точки (2)
  • To analyze the changes induced in the immunological profile after the intervention: -Humoral: IgE and IgG4 levels to peach LTP (Pru p 3) and palm tree profilin (Pho d 2) by immunoassays. [Срок оценки: 16 weeks]
  • To analyze the changes induced in the immunological profile after the intervention: 2.2-Cellular: activation of peach LTP basophils (Pru p 3) and palm profilin (Pho d 2) by flow cytometry. [Срок оценки: 16 weeks]

Критерии участия

Критерии включения

  • Males or females aged 14-55 years who sign the informed consent (IC) for the study and Biobank sample storage.
  • Allergy to plant foods due to sensitisation to LTP, patients allergic to profilin confirmed by a suggestive clinical history, positive skin tests and specific IgE to Pru p 3 (peach LTP) and Pho d 2 (Phoenix dactylifera profilin).
  • Positive oral challenge test (OPT) to peach and at least one other food in patients allergic to LTP and positive oral challenge test to melon and at least one other food in patients allergic to profilin.
  • Selection of a group of LTP-allergic individuals with therapeutic failure after treatment with ITSL-Pru p 3.

Критерии исключения

  • Pregnancy and lactation.
  • Immunological diseases; treatment with immunomodulatory and/or blocking drugs.
  • Mental illness, which makes it impossible to follow and adhere to treatment (e.g. major depression, psychosis, etc.).
  • Severe atopic dermatitis according to SCORAD 5: FEV1<70% (this test will be carried out as a priority in patients with a previous diagnosis of asthma).
  • Inflammation in the oral cavity with severe symptoms, as well as with oral surgery in the previous 7 days.
  • Immunotherapy with pollens in the previous 2 years.
  • Subjects unable to comply with the schedule of visits during the study, as well as due to the consumption of the food under investigation, for example, due to work difficulties.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07073404 · Omalizumab proyect

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗