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Evaluation the successful rate of Wheat Oral Immunotherapy to induce wheat tolerance in wheat allergic patients

Protocol summary

Summary
This is an interventional study investigating the efficacy, safety and immunological mechanisms of oral wheat desensitization therapy in wheat allergic children. Wheat allergic children who meet the inclusion criteria, are recruited to the study. Patients having uncontrolled asthma, other lung disease, cardiovascular disease or other significant systemic disease and patients having poor compliance are excluded. Anaphylaxis is confirmed by DBPCFC in all patients. At first all patients take Loratadine and Montelukast, to prevent the severe adverse reaction, three days prior to admission.then OFCs (oral food challenges) is performed to determine the initial dose of OIT. In build up phase, patients take cake. if they can take it without severe reactions, they were asked to take bread A, which contains 5.28 gr gluten in 100gr ( start from 15 , increase up to 30gr). the amount of bread increase twice a week . in third step they start from 20 gr of bread B, which contains 8.8 gr gluten in 100g. After finishing build up phase, they were asked to take 60g of bread in a day (maintenance phase). If they can keep taking wheat products without adverse reactions for 3 months, they will aske to eliminate wheat for 2 weeks, then they receive OFCs. If this challenges were negative, we regarde them as tolerant. If positive, we regarde them as desensitization conditions. In addition to clinical measures, some immunological mechanisms of desensitization (Skin prick test, Wheat sIgE, and total IgE) is measured at the first day, at the end of build up phase, and Maintenance phase.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013081214305N2
Registration date: 2015-04-04, 1394/01/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-04-04, 1394/01/15
Registrant information
Name
ِDelara Babaie
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7021
Email address
dbabaie@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Pediatric Infections Research Center of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Evaluation the successful rate of Wheat Oral Immunotherapy to induce wheat tolerance in wheat allergic patients
Public title
Oral immunotherapy in patient with wheat anaphylaxis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria 1. Wheat allergic children aged over 2 years with history of severe symptoms and positive SPT 2. Elevated serum wheat specific IgE 3. Immediate reaction in open oral wheat challenge test Exclusion Criteria: • Uncontrolled asthma • Other chronic lung or renal disease • Cardiovascular disease or other significant systemic disease • Patients having poor compliance
Age
From 2 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 16
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
Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Shahid Aarabi street, Yaman street, Shahid Chamran highway
City
Tehran
Postal code
Approval date
2014-12-15, 1393/09/24
Ethics committee reference number
13554-87-1-1393

Health conditions studied

1

Description of health condition studied
Wheath anaphylaxia
ICD-10 code
T78.0
ICD-10 code description
Anaphylactic shock due to adverse food reaction

Primary outcomes

1

Description
Level of total IgE in plasma
Timepoint
Start of oral immunothrapy,at the end of oral immunothrapy,after maintenace phase
Method of measurement
Measure of plasma level

2

Description
Level of specific IgE for wheat in plasma
Timepoint
Start of oral immunothrapy,at the end of oral immunothrapy,after maintenance phase
Method of measurement
Measure of plasma level

3

Description
Size of wheal and flare of wheat skin test
Timepoint
Start of oral immunotherapy,After maintenance phase
Method of measurement
Measure of size according millimeter

Secondary outcomes

empty

Intervention groups

1

Description
OFCs (oral food challenges) is performed to determine the initial dose of OIT. In build up phase, patients take cake. if they can take it without severe reactions, they were asked to take bread A, which contains 5.28 gr gluten in 100gr ( start from 15 , increase up to 30gr). the amount of bread increase twice a week . in third step they start from 20 gr of bread B, which contains 8.8 gr gluten in 100g.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mofid Children' s Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Pediatric Infections Research Center of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Delara babaie
Street address
Mofid Children's Hospital, Shariati street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pediatric Infections Research Center of Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mitra sahragard
Position
Pediatric resident
Other areas of specialty/work
Street address
Mofid Children's Hospital, Shariati street
City
Tehran
Postal code
Phone
+98 21 2222 7021
Fax
Email
Mitra.sahragard@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Delara babaie
Position
Assistant professor Allergy and Clinical Immunology
Other areas of specialty/work
Street address
Mofid Children's Hospital, Shariati street
City
Tehran
Postal code
Phone
+98 21 2222 7021
Fax
+98 21 2222 7033
Email
Dbabaie@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamideh seifi
Position
Pediatric resident
Other areas of specialty/work
Street address
Mofid Children's Hospital, Shariati street
City
Tehran
Postal code
Phone
+98 21 2222 7021
Fax
Email
Hamideh_s80@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
empty
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