Comparison of the effect of oral immunotherapy with cow's milk products and conventional desensitization in children with allergy to heated cow's milk: a clinical trial
Triple-blind randomized placebo controlled clinical trial, community based, two parallel group design with 25 patients suffering from type 1 hypersensitivity
Settings and conduct
In the allergy and immunology clinic patients were randomized into milk and muffins groups. for all patients before and after desensitization skin prick test, IgE serum level test, the eosinophil and T regulatory cell counting were performed. The study is triple-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients two years and older; presentation of skin symptoms such as urticaria, erythema and angioedem; gastrointestinal symptoms such as severe vomiting, abdominal pain and diarrhea; respiratory symptoms such as rhinitis and bronchospasm; these symptoms should be present up to two hours after exposure; these symptoms should be present at least in last six months; positive skin prick test for cow's milk or measurement of sIgE for cow's milk
Exclusion criteria:cellular immune response that it's not mediated by IgE; malignancy or severe immunodeficiency disorders; using beta blockers; uncontrolled severe persistent asthma; Cardiovascular disease that epinephrine administration in them is contraindicated; Taking immunosuppressive drugs; Eosinophilic Gastrointestinal;
Disorder that produced by the milk and it diagnosed
Intervention groups
In the intervention, 12 patients (2 female and 10 male) used heated cow milk (muffin). In control group, 13 patients (5 female and 8 male) underwent oral immunotherapy with cow milk.
Main outcome variables
Regulatory T cell; Specific IGE for milk; Milk Desensitization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170426033658N2
Registration date:2018-04-01, 1397/01/12
Registration timing:retrospective
Last update:2018-04-01, 1397/01/12
Update count:0
Registration date
2018-04-01, 1397/01/12
Registrant information
Name
Emad Bahraminiya
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 0024
Email address
bahraminia-e@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research , Tehran University of Medical Sciences
Expected recruitment start date
2016-04-29, 1395/02/10
Expected recruitment end date
2017-04-30, 1396/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral immunotherapy with cow's milk products and conventional desensitization in children with allergy to heated cow's milk: a clinical trial
Public title
clinical trial of the effect of raw and cooked milk immunotherapy in children with milk allergy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
patients two years and older
Presentation of skin symptoms such as urticaria, erythema and angioedema
gastrointestinal symptoms such as severe vomiting, abdominal pain and diarrhea
respiratory symptoms such as rhinitis and bronchospasm
Presentation of the symptoms up to two hours after exposure
these symptoms should be present at least in last six months
positive skin prick test for cow's milk or measurement of sIgE for cow's milk
positive challenge test with cow's milk
Exclusion criteria:
cellular immune response that is not mediated by IgE
malignancy or severe immunodeficiency disorders
using beta blockers
uncontrolled severe persistent asthma
Cardiovascular disease that epinephrine administration is contraindicated in them
Taking immunosuppressive drugs
previously diagnosed Eosinophilic Gastrointestinal Disorder in response to milk
Age
From 2 years old to 15 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Method of simple randomization
Blinding (investigator's opinion)
Triple blinded
Blinding description
1- participants, 2- Physicians, and nurses, who care for participants, 3- data analyser
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Siences, Poorsina ave, Gods ave, Enghelab street
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2016-11-22, 1395/09/02
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1395.1076
Health conditions studied
1
Description of health condition studied
food allergy
ICD-10 code
T78.4
ICD-10 code description
Allergy, unspecified
Primary outcomes
1
Description
regulatory T cell
Timepoint
Before intervention, after intervention
Method of measurement
Flow cytometry
2
Description
Specific IGE for milk
Timepoint
Before intervention, after intervention
Method of measurement
RIDA
3
Description
Milk Desensitization
Timepoint
Before intervention, after intervention
Method of measurement
Clinical
Secondary outcomes
1
Description
symptoms,anaphylaxis,desensitization
Timepoint
Immediately after intervention.
Method of measurement
physical examination
Intervention groups
1
Description
In the intervention group, certain amount of muffin is given to patients and they are monitored for 4 hours under medical observation. Then desensitization with 1.8 muffin's slice is initiated and the dosage will be added monthly (For 4 to 6 months) until it reaches one complete muffin.
Category
Other
2
Description
In the control group, certain amount of milk is given to patients and they are monitored for half an hour under medical observation. the desensitization is initiated with 0.1mL of cow's milk and the dosage will be added weekly (For 10 to 12 weeks) until it reaches the amount of 200 cc.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Center Hospital
Full name of responsible person
Dr.Emad Bahraminiya
Street address
No. 62, Qarib St, Keshavarz Blvd,
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6692 2115
Email
bahraminiya.emad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research of Tehran University of Medical Sciences
Full name of responsible person
Masood Yunesian
Street address
Sixth floor,Central Organization of Tehran University,Qods street,Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8163 3685
Email
yunesian@tums.ac.ir
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research of Tehran University of Medical Sciences
Proportion provided by this source
100
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
Dr.Emad Bahraminiya
Position
fellowship of allergy and clinical immunology
Latest degree
Subspecialist
Other areas of specialty/work
Immunology
Street address
No 62, Qarib St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 61479
Fax
Email
bahraminiya.emad@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Masoud Movahedi
Position
Full Professor
Latest degree
Subspecialist
Other areas of specialty/work
Immunology
Street address
No. 62, Qarib St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 61479
Fax
Email
movahedm1@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Emad Bahraminiya
Position
fellowship of allergy and clinical immunology
Latest degree
Subspecialist
Other areas of specialty/work
Immunology
Street address
No. 62, Qarib St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 61479
Fax
Email
bahraminiya.emad@gmail.com
Web page address
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
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
IPD collected for the primary outcome measure only
When the data will become available and for how long
starting 2 months after publication
To whom data/document is available
people working in academic institutions and clinical immunology specialist
Under which criteria data/document could be used
use of data for systematic review articles
From where data/document is obtainable
email address: bahraminiya.emad@gmail.com
What processes are involved for a request to access data/document
Just ask for an email and send it within less than a week.