In this study, patients over 3 years with TYPE 1 HYPERSENSIVITY which Has been confirmed based on history ;physical exam . skin test ,immunocap.and double blind placebo control challenge test, have been considered for cow’s milk oral immunotherapy with Specific Protocols. We do immunoterapy According to the patients history and positive result of DBPCFC ; The study consisted of three phases : rash and climbing and maintenance. This study have been done on an outpatient basis at the hospital. amount of milk be given to patients slowly until a dose of 200-250 mL within a few weeks. Patients eat 200 to 250 ml of milk for 3 months After completion of the ascending phase (maintenance phase). If Patients able to eat milk products without advers reaction for one year the food challenge test (OFC) is done to check the status of tolerance Once again. So that consumption of milk Stops for 2 weeks and OFC tests are done for patients. If the challenge test was positive means that not created tolerance in patients,they have been desensitization and Should consume milk daily. If the challenge test was negative means that created tolerance in patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015041621793N1
Registration date:2015-06-15, 1394/03/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-15, 1394/03/25
Registrant information
Name
Mohsen Ebrahimi
Name of organization / entity
Tehran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6147
Email address
ebrahimi.m@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral immunotherapy with cows milk in desensitizaition and induce tolerance in patients with cows milk allergy
Public title
Effect of oral immunotherapy in improving Sensitivity in Patients with cow's milk Allergy
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:patients above 3 years old with IgE mediated cow's milk allergy which confirm challenge test
exclusion criteria:lack of parental and patient consent,non IgE mediated allergy to cows milk and uncontrolled severe asthma.
Age
From 3 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
14
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
Children Medical Center, Keshavarz Blvd, Dr Gharib St, Tehran, IR Iran
City
Tehran
Postal code
1417653761
Approval date
2015-03-04, 1393/12/13
Ethics committee reference number
6211568003-140288
Health conditions studied
1
Description of health condition studied
Food allergies
ICD-10 code
T78.0
ICD-10 code description
Anaphylactic shock following adverse reactions Food
Primary outcomes
1
Description
Create tolerance to cow's milk
Timepoint
One year after the end of intervention
Method of measurement
clinical signs and open food challenge test
2
Description
Desensitization to cow's milk
Timepoint
6 months after starting intervention
Method of measurement
Based on clinical signs
Secondary outcomes
1
Description
Changes in the level of specific IgE
Timepoint
before starting intervention and six months after the end of intervention
Method of measurement
RIDA test
2
Description
Changes in skin test before and after desensitization
Timepoint
before starting intervention and 6 months after the end of the intervention
Method of measurement
Skin Prick Test
Intervention groups
1
Description
In this study,A certain amount of milk are given to patients under medical supervision and a half hours to be considered.the desensitization beginning with 0.1mL of cow's milk, and increasing the dosage weekly(For 10 to 12 weeks) until to reaching a dose of 200 mL of milk.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Childrens Medical Center
Full name of responsible person
Mohsen Ebrahimi
Street address
Children Medical Center, Keshavarz Blvd, Dr Gharib St, Tehran, IR Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohsen Ebrahimi
Street address
Children Medical Center, Keshavarz Blvd, Dr Gharib St, Tehran, IR 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
Childrens Medical Center
Full name of responsible person
Mohsen Ebrahimi
Position
Allergy and Immunology Fellowship
Other areas of specialty/work
Street address
Children Medical Center, Keshavarz Blvd, Dr Gharib St, Tehran, IR Iran
City
tehran
Postal code
Phone
+98 21 6693 3926
Fax
Email
ebrahimi.m@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Childrens Medical Center
Full name of responsible person
Mohsen Ebrahimi
Position
Allergy and Immunology Fellowship
Other areas of specialty/work
Street address
Children Medical Center, Keshavarz Blvd, Dr Gharib St, Tehran, IR Iran
City
Tehran
Postal code
Phone
+98 21 6693 3926
Fax
Email
ebrahimi.m@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Childrens Medical Center
Full name of responsible person
Mohsen Ebrahimi
Position
Allergy and Immunology Fellowship
Other areas of specialty/work
Street address
Children Medical Center, Keshavarz Blvd, Dr Gharib St, Tehran, IR Iran
City
Tehran
Postal code
Phone
+98 21 6693 3926
Fax
Email
mohsen_dr_ebrahimi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)