Oral Immunotherapy With Egg in Infants

ConditionFood Allergy in Infants

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age12-36

SponsorJosefine Gradman

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

positive specific IgE to egg

positive oral provocation for egg

low threshold

Disqualifiers

uncontrolled astham treatment with biologics or immunsupressive drugs treatment with antihistamines

Trial population

Children that within 4 months have undergone a positive provocation with egg with a low threshold at Hans Christian Andersen Children's Hospital

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

low-dose OIT egg
Other intervention
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

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: OIT egg1 intervention

Group B: Non-OIT0 interventions

Trial outcomes

Primary outcomes

Percentage of children who develops tolerance to egg per year

Once a year the children will undergo an oral food provocation with egg to investigate if they have becomed tolerant to egg

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 outcomes

specific IgE

Measurement of specific IgE to egg in the blood

Time frame

baseline and through study completion, an average of 1 year

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Josefine Gradman

Lead sponsor

Odense University Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: