Desensitization to wheat in patients with anaphylactic reaction to wheat
Design
Clinical Trial without control group, single and non-randomized. To confirm the diagnosis of wheat allergy, food challenge is performed for all patients.
Settings and conduct
In this interventional study, desensitization of wheat is carried out in patients referred to the Children Medical Center. Skin Prick test is performed with wheat extract. Specific IgE level of the wheat and T regulatory cell are measured. To confirm the diagnosis of wheat allergy, food challenge is performed for all patients.The patients with anaphylactic reaction to wheat were treated with rush method.
Participants/Inclusion and exclusion criteria
Inclusion and exclusion Criteria: Age more than 5 years, A positive history of severe allergy to wheat, A positive specific IgE to wheat,Confirmation of wheat allergy by OFC/Dissatisfaction of the patients or their parents, Viral or bacterial infectious diseases, Unstable or uncontrolled asthma, Use of medications
Intervention groups
Considering the clinical history and adverse reactions developed in OFC, the patients with anaphylactic reaction entered the study. Intervention group were patients with anaphylactic reactions.The patients with anaphylactic reaction were treated with rush methods.
Main outcome variables
Desensitization to wheat,-Complications,-Tolerance to wheat, Prick test
Specific IgE to Wheat,T reg cells count
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181220042066N1
Registration date:2020-09-22, 1399/07/01
Registration timing:retrospective
Last update:2020-09-22, 1399/07/01
Update count:0
Registration date
2020-09-22, 1399/07/01
Registrant information
Name
Samin Sharafian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6642 8996
Email address
s-sharafian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
2015-08-23, 1394/06/01
Actual recruitment end date
2018-02-04, 1396/11/15
Trial completion date
2018-02-04, 1396/11/15
Scientific title
Desensitization to wheat and relationship of tolerance in patients with T regulatory and specific IgE levels
Public title
Desensitization to wheat
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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)
Exclusion criteria:
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
Age
From 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
More than 1 sample in each individual
Number of samples in each individual:
2
Serum samples
Actual sample size reached:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Siences
Street address
Tehran University of Medical Sciences, Keshavarz Blvd. , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733151
Approval date
2017-08-14, 1396/05/23
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.3196
Health conditions studied
1
Description of health condition studied
Wheat Allergy, Anaphylaxis, Food Allergy
ICD-10 code
T78.0
ICD-10 code description
Anaphylactic reaction due to food
Primary outcomes
1
Description
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
Description
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
Secondary outcomes
1
Description
percentage of T regulatory cells
Timepoint
Before and after Immunotherapy
Method of measurement
Flowcytometry
2
Description
Wheal and flare in Skin Prick Test
Timepoint
Before and after Immunotherapy
Method of measurement
observation of wheal and flare
3
Description
Specific IgE level to wheat
Timepoint
Before and after Immunotherapy
Method of measurement
Immunoblotting test Allergy screen
4
Description
Complications
Timepoint
Before and after Immunotherapy
Method of measurement
examination and observation of clinical symptoms
Intervention groups
1
Description
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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Children Medical Center
Full name of responsible person
Samin Sharafian
Street address
Dr. Gharib Street
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6692 9234
Fax
+98 21 6693 0024
Email
samin.sh2020@yahoo.com
Web page address
http://chmc.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Keshavarz Blv.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Fax
+98 21 8163 3611
Email
rmo@tums.ac.ir
Web page address
http://vcr.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
80
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Samin Sharafian
Position
Fellow in training (Allergy and Clinical Immunology)
Latest degree
Specialist
Other areas of specialty/work
Immunology
Street address
Children Medical Center
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 3926
Fax
+98 21 6693 0024
Email
samin.sh2020@yahoo.com
Web page address
http://chmc.tums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoud Movahedi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Immunology
Street address
Children’s Medical Center, No 63, Gharib Ave, Keshavarz Blv, and Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 3926
Fax
+98 21 6693 0024
Email
movahedm1@gmail.com
Web page address
http://chmc.tums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Samin Sharafian
Position
Fellow in training(Allergy and clinical Immunology)
Latest degree
Specialist
Other areas of specialty/work
Immunology
Street address
Children’s Medical Center, No 63, Gharib Ave, Keshavarz Blv, and Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 3926
Fax
+98 21 6693 0024
Email
samin.sh2020@yahoo.com
Web page address
http://chmc.tums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
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 the data will become available and for how long
After article publication
To whom data/document is available
Sub-specialists in Allergy and clinical Immunology in academic hospitals and centers
Under which criteria data/document could be used
Sub-specialists in Allergy and clinical Immunology in academic hospitals and centers
From where data/document is obtainable
Dr. Samin Sharafian Tel: 00989113782097 Email: samin.sh2020@yahoo.com
What processes are involved for a request to access data/document
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.