The purpose of this study is oral desensitization therapy of 15 patients with wheat allergy.The study population are the patients above 5 years with IgE-mediated wheat allergy (positive skin prick test to wheat flour extract and wheat specific IgE level above 0.35 IU/L) who don't have severe asthma, chronic urticaria and other severe systemic disease. According to patient’s history and their symptoms that occur during double-blind placebo-controlled food challenge test, the patients are divided into two groups with anaphylaxis and without anaphylaxis. We perform Rush Oral Immunotherapy (ROIT) for anaphylactic type and outpatient method for non-anaphylactic type of wheat allergy. Our protocol is consisting of initial build up phase following maintenance phase. Maximum dose during build up phase is 5.2 g wheat protein. We use bread for OIT. In ROIT the patients hospitalize and build up phase perform during several days but in outpatient method the amount of ingestion gradually increase to 52 g of bread (containing 5.2 g wheat protein) within several weeks. After completion the buildup phase, the patients are asked to ingest the maintenance dose (52 g of bread) "daily" for 3 months. In both groups if they are able to take wheat products without adverse reactions for 3 months, they receive confirmed OFC with 5.2 g wheat protein. If this challenge is negative, we regard them as desensitized state and they can ingest wheat products freely without interruption.
General information
Acronym
Wheat Oral Immunotherapy
IRCT registration information
IRCT registration number:IRCT201204199510N1
Registration date:2014-02-26, 1392/12/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-26, 1392/12/07
Registrant information
Name
Alireza Khayatzadeh
Name of organization / entity
Department of Allergy and Clinical Immunology, Children's Medical Center at Tehran University of Med
Country
Iran (Islamic Republic of)
Phone
+98 61472153
Email address
a-khayatzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy and safety of wheat oral immunotherapy in patient with wheat allergy
Public title
Wheat oral desensitization in patient with wheat allergy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients above 5 years with IgE mediated wheat allergy (positive skin prick test response to wheat flour and wheat specific IgE level above 0.35 IU/L); positive oral food challenge to wheat.
exclusion criteria: severe and uncontrolled asthma; chronic urticaria; significant systemic disease; poor compliance
Age
From 5 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
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
Tehran University of Medical Sciences
Street address
Office of TUMS Public Relations, sixth Floor,Ghods street, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2012-12-31, 1391/10/11
Ethics committee reference number
91/d/130/2505
Health conditions studied
1
Description of health condition studied
wheat allergy
ICD-10 code
T78
ICD-10 code description
Adverse effects, not elsewhere classified
2
Description of health condition studied
Desensitization
ICD-10 code
Z51.6
ICD-10 code description
Desensitization to allergens
Primary outcomes
1
Description
Daily consumption of wheat products without any complications
Timepoint
Before oral immunotherapy and 3 month after starting maintenance phase
Method of measurement
Oral food challenge with 52 gr of bread containing 5.2 g wheat protein
Secondary outcomes
1
Description
Evaluation of skin, respiratory, gastrointestinal symptoms and anaphylaxis reaction during course of treatment
Timepoint
During buildup and maintenance phase
Method of measurement
Number of participants with adverse events and observation of their sign and symptoms
Intervention groups
1
Description
The anaphylactic patients take Loratadine and Montelukast, three days prior to admission to prevent the severe adverse reaction. On the first day of admission; we perform OFC again with premedication, so we determine the initial dose of rush OIT. In rush phase, patients take bread two time a day, and if they can take them without severe reactions, they are asked to take bread with 50% increase of the former dose. Maximum amount of bread is set at 52 g of bread. In outpatient method after the OFC, the patients are asked to ingest a small amount of wheat at home every day. The initial protein dose is about 1/4 of the threshold to elicit positive symptoms in OFC without premedication. Amount of wheat ingestion gradually buildup to 52 g of bread that contain 5.2g of wheat protein according to their symptoms. In both groups after completion of build-up phase, the patients are asked to ingest 52 g of bread containing 5.2 g wheat protein as a maintenance dose "daily" for 3 months. During this period the patients should continue the wheat-elimination diet. َََAt the end of maintenance phase we performed OFC with 52 g of bread (containing 5.2 g wheat protein). If the patients could pass the test, we regarded them as desensitized, and after that they could ingest wheat products without any restrictions. The patients who completed treatment had to eat at least 5.2 g wheat protein every day since we were not sure whether they have got tolerance or not. Moreover it is not difficult for most of people to eat 5.2 g wheat protein per day, because they usually have the same amount of wheat products in their daily diet.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Cernter Hospital
Full name of responsible person
Alireza Khayatzadeh
Street address
Children' Medical Center, Dr.Gharib st, Keshavarz Blvd, Tehran 14194, I.R. of Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Office of TUMS Public Relations, sixth Floor, Ghods St., Keshavarz Blvd. Vali-e-Asr Ave., Tehran, Iran.
City
Tehran
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
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Allergy and Clinical Immunology in Children's Medical Center at Tehran University of M
Full name of responsible person
Alireza Khayatzadeh
Position
Fellow of allergy and clinical immunology
Other areas of specialty/work
Street address
Children' Medical Center, Dr.Gharib st, Keshavarz Blvd, Tehran 14194, I.R. of Iran
City
Tehran
Postal code
Phone
+98 21 6147 2153
Fax
Email
a-khayatzadeh@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Allergy and Clinical Immunology of Children's Medical Center at Tehran University of M
Full name of responsible person
Masoud Movahedi
Position
Associate Professor
Other areas of specialty/work
Street address
Children' Medical Center, Dr.Gharib st, Keshavarz Blvd, Tehran 14194, I.R. of Iran
City
Tehran
Postal code
Phone
+98 21 6147 2153
Fax
Email
movahedm@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Allergy and Clinical Immunology of Children's Medical Center at Tehran University of M
Full name of responsible person
Alireza Khayatzadeh
Position
Fellow of allergy and clinical immunology
Other areas of specialty/work
Street address
Children' Medical Center, Dr.Gharib st, Keshavarz Blvd, Tehran 14194, I.R. of Iran
City
Tehran
Postal code
Phone
+98 21 6147 2153
Fax
Email
a-khayatzadeh@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)