Oral Immunotherapy With Egg in Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: low-dose OIT egg.
- Who it may be relevant to
- Registry conditions: Food Allergy in Infants. Basic parameters: 12 months — 36 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Oral Immunotherapy With Egg
Overview
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.
Detailed description
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
Interventions
- Other 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
Primary outcome measures
- Percentage of children who develops tolerance to egg per year [Time frame: 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]
Secondary outcome measures (1)
- specific IgE [Time frame: baseline and through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- positive specific IgE to egg
- positive oral provocation for egg
- low threshold
Exclusion criteria
- uncontrolled astham treatment with biologics or immunsupressive drugs treatment with antihistamines
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07540091 · HCA-OIT_egg