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IRCT20180116038387N1 IRCT 2018-02-26 Iran University of Medical Sciences Effectiveness of Oral Immunotherapy in patients with allergy to egg white The effectiveness of oral immunotherapy with egg white for desensitizing the patients with IgE mediated sensitization to egg white and comparison with the control group 2018-02-04 anticipated 14 Complete https://irct.ir/trial/28989 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples were randomly selected(according to random number table) from patients referred to the Asthma and Allergy Clinic of Rasool Akram Hospital and Allergy Clinic of Jahad , Blinding description: After obtaining informed consent from all the patients to participate in the study, they will not inform about dividing them in groups(Immunotherapy or placebo). N/A Condition 1: IgE-mediated sensitization to Egg white. Condition 2: IgE-mediated sensitization to Egg white. Intervention 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 epinephrine and Prednisolone and Salbutamol will be added.The interval between escalating doses is 4 hours. In case of a mild, moderate and severe reactions will be returned to one and two previous phases. Also, to control the possible anaphylactic attack in the maintenance phase, necessary training will be given to the patient or their parents.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is A few studies have been done in the field of oral Immunotherapy in Iran and we would like to continue this process in the future projects. So, the time of publishing the data file has been not defined.
public Dr. Vahid Ghobadi Dana
Hazrat Rasoul Akram Hospital, Niayesh Street, Sattarkhan Street, Tehran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6651 4001 drghobadidana@yahoo.com Iran University of Medical Sciences scientific Dr. Vahid Ghobadi Dana
Hazrat Rasoul Akram Hospital, Niayesh Street, Sattarkhan Street,Tehran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6655 9595 drghobadidana@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) The patients referring to Department of Asthma and Allergy in Rasool Akram Hospital and Jahad Clinic with a history of allergic reaction to egg white up to 2 hours after ingestion and positive Skin Prick test to Egg white The inability to pass the Oral Food Challenge (OFC) according to the protocol of Middelton Book with using pasteurized raw egg white (Produced by Telavang Egg Industries Co.) 4 years no limit Both Age less than 4 years old History of Cardiovascular diseases Use of Beta-Blockers and ACE Severe and Uncontrolled Asthma T78.0 T78.1 Anaphylactic reaction due to food Other adverse food reactions, not elsewhere classified Treatment - Other Intervention 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 epinephrine and Prednisolone and Salbutamol will be added.The interval between escalating doses is 4 hours. In case of a mild, moderate and severe reactions will be returned to one and two previous phases. Also, to control the possible anaphylactic attack in the maintenance phase, necessary training will be given to the patient or their parents. Desensitization. Timepoint: 6 months. Method of measurement: Pass the Oral food challenge test after 6 months use of egg white. Specific IgE concentration to Egg white. Timepoint: 6 months. Method of measurement: Immunocap. Specific IgG4 concentration to Egg white. Timepoint: 6 months. Method of measurement: ImmunoCAP. The size of Skin Prick Test. Timepoint: 6 months. Method of measurement: The size of wheal and Flare(mm). Telavang Company Dr. Vahid Ghobadi Dana Iran University of Medical Sciences Telavang Company Dr. Vahid Ghobadi Dana Approved 2018-01-15 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)