Oral Immunotherapy With Egg in Infants

Официальное название

Oral Immunotherapy With Egg

Обзор

In children allergic to egg, oral immunotherapy (OIT) with egg may accelerate that the children grow out of the food allergy. Children than have a positive oral food provocation with egg with a low threshold, will be offered to start OIT. This means that the child have to ingest a small amount of egg every day. Once a year, the child will undergo a new oral food provocation to investigate if the child is still allergic to egg or not. The age of the children at time of this acquired tolerance will be compared with a historical cohort of children with egg allergy.

Подробное описание

The aim of the study is to investigate if OIT with egg white can accelerate tolerance to egg in infants with provocation-verified allergy to egg and with a low threshold.

The study is non-randomised. Children fulfilling the inclusion criteria will be offered OIT. The children will undergo an oral provocation once a year to detect development of tolerance to egg. Age at tolerance acquisition will be compared with a histical cohort of aged-matched children with allergy to egg and with a similar threshold at the diagnostic provocation

Вмешательства

• Другое low-dose OIT egg
  The children have to ingest a small specified amount of egg white every day. The amount will gradually increase, as the child becomes more and more tolerant to egg

Первичные конечные точки

• Percentage of children who develops tolerance to egg per year [Срок оценки: If the oral food provocation is negative (that is the child is still allergic to egg) the child will be re-provocated after 12 months. As long as the provocation is positive it will be repeated once a year for 5 years]

Вторичные конечные точки (1)

• specific IgE [Срок оценки: baseline and through study completion, an average of 1 year]

Критерии участия

Критерии включения

• positive specific IgE to egg
• positive oral provocation for egg
• low threshold

Критерии исключения

• uncontrolled astham treatment with biologics or immunsupressive drugs treatment with antihistamines

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07540091 · HCA-OIT_egg

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗