The patients referring to Department of Asthma and Allergy, Rasool Akram Hospital, and Jahad Clinic with an allergy to egg white up to 2 hours after ingestion and positive Skin Prick test to Egg white enter the study. All patients aged 4 years and older who have a history of IgE-mediated hypersensitivity to egg white enter in the study. At the first step, oral food challenge will be done for the subjects without a clear IgE mediated reaction to egg white in the last 6 months.The subjects with a positive reaction to OFC will be included in the study. At the beginning of the study, the skin prick test (SPT) will be performed for egg white, egg yolk, and five major food allergens including wheat, soy, milk, peanut, fish, and sesame. The baseline concentration of specific IgE and IgG4 to egg white and ovomucoid will be measured. These tests will be repeated at the end of the maintenance phase (after 6 months).
The patients were randomly divided into two groups: egg white and the placebo group. Three phase including an initial dose escalation during 5 days of hospitalization, to continue the use of received dose at home, to increase the dose up to achieve maintenance dose and maintain dose after 6 months according to the protocol of use of pasteurized raw egg white( produced by Telavang Co.). To escalate the dose in build-up phase, the patients will be hospitalized for 5 days in Rasool Akram Hospital. Obviously, during the hospitalization and the build-up phase, all treatment will be available to manage the possible attack of an anaphylactic reaction.
For the safety of the patients, premedication will be done with the antihistamine (H1 and H2) and ALRA. In case of a mild reaction, antihistamines will be administered, and in case of intermediate and severe reactions, intramuscular epinephrineو Prednisolone and Salbutamol will be added.The interval between escalating doses is 4 hours. In case of a mild, moderate and severe reactions the phases will be returned to one and two previous phase. Also, to control the possible anaphylactic attack in the maintenance phase, necessary training will be given to the patient or their parents.
The sue of egg white will be continued for 6 months at home. After 6 months, the patient will be referred to measure the size of skin prick test (SPT) and the serum level of IgE and IgG4 to egg white and ovomucoid. Additionally, at the end of 6th month, to evaluate the success rate of desensitization, OFC will be done for all patients.
The dose table of Egg white in OFC
0.3 CC
1.2 CC
3 CC
4.5 CC
6 CC
7.5 CC
Total 30 cc
In the patients with an anaphylactic reaction, OFC starting dose will be equal to 0.015cc (1mg egg protein).
The dose table of Egg white in Build up
0.1CC
0.2CC
0.4CC
0.8CC
1.5CC
3 CC
4.5CC
6 CC
8CC
12 CC
16CC
20 CC
Selecting the starting dose for the Build up phase is based on the OFC reaction .