A Long Term, Observational Follow-Up Study of Children and Young People Who Underwent an 18-Month Course of Oral Immunotherapy Treatment for Peanut, Egg or Milk Allergy (5-15 Years Post-Treatment)
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Food Allergies, Peanut Allergies, Egg Allergy, Milk Allergy. Базовые параметры: Без ограничений · 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
- Австралия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Long Term Outcomes Associated With Attainment of Remission Following Oral Immunotherapy to Peanut, Egg and Cow's Milk (LPEM Study)
Обзор
The goal of this observational study is to learn about the long-term outcomes of children and young people who underwent an 18-month course of oral immunotherapy (OIT) treatment for peanut, egg or milk allergy. It aims to: • Compare long-term changes in health-related quality of life (HRQL) at 5-15 years after stopping OIT in participants who achieved remission and those who did not. Participants will attend a single follow-up visit for: * A blood test * Skin prick test (SPT) * Allergy questionnaires
Подробное описание
The study population will be made up of participants from four clinical trials: PEAT, PrEMO, PPOIT-001 and PPOIT-002. They are being invited to participate in the LPEM observational study to evaluate the long-term outcomes of OIT.
* PEAT: Egg OIT. These participants are from the PEAT parent study (double-blind placebo-controlled randomized trial of probiotic and egg OIT). * PrEMO: Egg or Milk OIT. These participants are from the PrEMO parent study (open label study of probiotic and egg and cow's milk OIT). * PPOIT-001: Peanut OIT. These participants are from the PPOIT-001 parent study (double-blind placebo-controlled randomized trial of probiotic and peanut OIT). * PPOIT-002: Peanut OIT. These participants are from the PPOIT-002 parent study (open label study of probiotic and peanut OIT).
Participants will have a blood sample taken at the visit to measure their peanut/egg/milk specific immunoglobulin E (sIgE) level. Plasma and peripheral blood mononuclear cells (PBMC) will also be stored for future analysis. A maximum of 50 milliliters (mL) of blood will be collected via venipuncture. If collection of blood via venipuncture is not possible, capillary blood via fingerprick technique will be collected instead (in which case only blood for the sIgE level will be collected, due to volume).
Participants will have a skin prick test completed at the visit to measure their allergy status. The skin prick test will include the following extracts:
* Positive control (histamine) * Negative control (saline) * House Dust Mite * Rye Grass * Peanut, Egg or Milk (depending on the participant's OIT treatment received in the parent study)
Первичные конечные точки
- Changes in health-related quality of life (HRQL) scores from baseline to 5-15 years after stopping oral immunotherapy (OIT) in individuals who achieved remission and those who did not, as measured by Food Allergy Quality of Life Questionnaires (FAQLQ). [Срок оценки: A single study visit (approximately 2 hours) will be conducted at 5-15 years after the participant completed OIT in their parent study.]
Вторичные конечные точки (6)
- Changes in HRQL scores from baseline to 5-15 years after stopping OIT in individuals who received OIT and those who received OIT placebo, as measured by FAQLQ. [Срок оценки: A single study visit (approximately 2 hours) will be conducted at 5-15 years after the participant completed OIT in their parent study.]
- The incidence and severity of allergic reactions (in the preceding 12 months) at 5-15 years after stopping OIT in individuals who achieved remission and those who did not, as measured by REDCap Allergen Specific Questionnaire. [Срок оценки: A single study visit (approximately 2 hours) will be conducted at 5-15 years after the participant completed OIT in their parent study.]
- The incidence and severity of allergic reactions (in the preceding 12 months) at 5-15 years after stopping OIT in individuals who received OIT and those who received OIT placebo, as measured by REDCap Allergen Specific Questionnaire. [Срок оценки: A single study visit (approximately 2 hours) will be conducted at 5-15 years after the participant completed OIT in their parent study.]
- Patterns of food ingestion (in the preceding 12 months) at 5-15 years after stopping OIT in individuals who achieved remission and those who did not, as measured by REDCap Allergen Specific Questionnaire. [Срок оценки: A single study visit (approximately 2 hours) will be conducted at 5-15 years after the participant completed OIT in their parent study.]
- Changes in immunological markers from baseline to 5-15 years after stopping OIT in individuals who achieved remission and those who did not, as measured by allergen specific immunoglobulin E (sIgE) blood levels. [Срок оценки: A single study visit (approximately 2 hours) will be conducted at 5-15 years after the participant completed OIT in their parent study.]
- Changes in immunological markers from baseline to 5-15 years after stopping OIT in individuals who received OIT and those who received OIT placebo, as measured by allergen specific immunoglobulin E (sIgE) blood levels. [Срок оценки: A single study visit (approximately 2 hours) will be conducted at 5-15 years after the participant completed OIT in their parent study.]
Критерии участия
Критерии включения
- Previous participant of PEAT, PrEMO, PPOIT-001 or PPOIT-002 parent study
- Received at least one dose of OIT treatment in the parent study
- Written informed consent from participant and/or parent/guardian (if below 18 years of age)
Критерии исключения
-Have any conditions that, in the opinion of the investigator, precludes participation for reason of safety
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Австралия · 1 центр
- Murdoch Children's Research Institute — Parkville
Идентификаторы
NCT: NCT07359183 · 121398