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IRCT20181220042066N1 IRCT 2020-09-22 Tehran University of Medical Sciences Desensitization to wheat Desensitization to wheat and relationship of tolerance in patients with T regulatory and specific IgE levels 2016-08-22 anticipated 12 Complete https://irct.ir/trial/38022 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Wheat Allergy, Anaphylaxis, Food Allergy. Intervention group : Patients with anaphylactic reactions to wheat underwent with Rush Method. Patients underwent the premedication with Cetirizine and Montelukast for three days. Then, they were admitted to spend the early phase of rush oral immunotherapy in the department of allergy and immunology. The treatment protocol has a buildup phase and a maintenance phase. The early dose is determined based on the result of oral food challenge. In the rush method, the specific amount of sandwich bread (Senan company) containing known content of wheat protein was given to the patient twice a day. In the case of tolerance and lack of severe symptoms, the amount of bread increased to reach the amount 5.2 grams of wheat protein (equivalent to 52 grams of sandwich bread). The next dose of wheat was determined based on the severity of the symptoms appearing in the previous dose. In the case of mild symptoms, the dose is gradually increased to reach a dose of 5.2 grams of wheat protein, and if moderate symptoms appear, increasing the dose is stopped. This phase was followed by maintenance phase for three months. In the maintenance phase, after increasing dose and consumption of 52 grams Senan sandwich bread, patients should consume this amount of bread daily for up to 3 months. During this period, patients should follow a wheat-free diet in addition to therapeutic doses. After the maintenance period, patients are allowed to gradually use of other foods containing wheat, and in the absence of symptoms, consume products containing wheat, freely. They should not stop consuming the wheat and should consume at least 5.2 grams of wheat protein daily.. Yes - There is a plan to make this available What will be shared: The new protocol of immunotherapy for wheat, informed consent and clinical reports of patients, and the results obtained in this study will be provided for sub-specialists in Allergy and Clinical Immunology and researchers after the publication of the article. When: After article publication To whom: Sub-specialists in Allergy and clinical Immunology in academic hospitals and centers Conditions: Sub-specialists in Allergy and clinical Immunology in academic hospitals and centers Where to obtain: Dr. Samin Sharafian Tel: 00989113782097 Email: samin.sh2020@yahoo.com How to obtain: After submitting a request by the applicant, his resume on wheat Immunotherapy will be reviewed. After consulting and approval of the professors, the data and protocols will be sent to them within a month. Comments:
public Samin Sharafian
Children Medical Center
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6693 3926 samin.sh2020@yahoo.com Tehran University of Medical Sciences scientific Masoud Movahedi
Children’s Medical Center, No 63, Gharib Ave, Keshavarz Blv, and Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6693 3926 movahedm1@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age more than 5 years A positive history of severe wheat allergy (Anaphylaxis) A positive specific IgE to wheat (in vivo or in vitro tests) Confirmation of wheat allergy by a oral food challenge (OFC) 5 years no limit Both Dissatisfaction of patients or their parents to perform OFC Viral or bacterial infectious diseases Unstable or uncontrolled asthma in the time of OFC Use of medications in the time of skin prick test (SPT) or DBPCFC T78.0 Anaphylactic reaction due to food Treatment - Other Intervention group : Patients with anaphylactic reactions to wheat underwent with Rush Method. Patients underwent the premedication with Cetirizine and Montelukast for three days. Then, they were admitted to spend the early phase of rush oral immunotherapy in the department of allergy and immunology. The treatment protocol has a buildup phase and a maintenance phase. The early dose is determined based on the result of oral food challenge. In the rush method, the specific amount of sandwich bread (Senan company) containing known content of wheat protein was given to the patient twice a day. In the case of tolerance and lack of severe symptoms, the amount of bread increased to reach the amount 5.2 grams of wheat protein (equivalent to 52 grams of sandwich bread). The next dose of wheat was determined based on the severity of the symptoms appearing in the previous dose. In the case of mild symptoms, the dose is gradually increased to reach a dose of 5.2 grams of wheat protein, and if moderate symptoms appear, increasing the dose is stopped. This phase was followed by maintenance phase for three months. In the maintenance phase, after increasing dose and consumption of 52 grams Senan sandwich bread, patients should consume this amount of bread daily for up to 3 months. During this period, patients should follow a wheat-free diet in addition to therapeutic doses. After the maintenance period, patients are allowed to gradually use of other foods containing wheat, and in the absence of symptoms, consume products containing wheat, freely. They should not stop consuming the wheat and should consume at least 5.2 grams of wheat protein daily. 1- Evaluation of desensitization to wheat. Timepoint: Evaluation of desensitization to wheat after 12 months after Immunotherapy. Method of measurement: 1- Skin Prick Test,2- Specific IgE measurement, 3-clinical symptoms and oral food challenge. 2-Evaluation of tolerance to wheat. Timepoint: Evaluation of tolerance to wheat after use of free wheat products for two weeks. Method of measurement: clinical symptoms and oral food challenge. Percentage of T regulatory cells. Timepoint: Before and after Immunotherapy. Method of measurement: Flowcytometry. Wheal and flare in Skin Prick Test. Timepoint: Before and after Immunotherapy. Method of measurement: observation of wheal and flare. Specific IgE level to wheat. Timepoint: Before and after Immunotherapy. Method of measurement: Immunoblotting test Allergy screen. Complications. Timepoint: Before and after Immunotherapy. Method of measurement: examination and observation of clinical symptoms. Tehran University of Medical Sciences Approved 2017-08-14 Ethics committee of Tehran University of Medical Siences Tehran University of Medical Sciences, Keshavarz Blvd. , Tehran, Iran Tehran Tehran Iran (Islamic Republic of)