The assessment of specificity of Double Dose Oral Food Challenge in predicting of permanent tolerance development in patient with history of anaphylaxis to cows milk under subject of desensitization
evaluation of usefulness of Double Dose Oral Food Challenge plus Specific IgE & IgG4 and size of weal in prick and prick to prick test in prediction of permanent tolerance development in cow`s milk anaphylaxis whome underwent desensitization.
Design
in this study, 22 patient with a history to anaphylaxis to cows milk protein that underwent desensitization and fulfill the inclusion criteria will recruit to Allergic clinic of Rasoul e Akram hospital and will be tested with Specific IgE & IgG4 , prick and prick to prick and Double Dose Oral food challenge test, then all of them will be strict avoided of cow`s milk for 3 weeks and after that standard oral food challenge will be done again.
Settings and conduct
patient with a history of anaphylaxia to cows milk protein under the subject of desensitization that refer to Rasool Allergic clinic
Participants/Inclusion and exclusion criteria
The patient with a history of anaphylaxis to cows milk allergy under subject to desensitization, 24 months after desensitization and history of any symptoms during the last 3 months, and consent to participate to project.
Intervention groups
there is no control group. all the permanent patients with anaphylaxis to cows milk whom underwent desensitization and eligible inaccording to inclusion criteria, will be assessed by: assessment of Specific IgE & IgG4 , prick and prick to prick and Double Dose Oral food challenge test, then all of them will be strict avoided of cow`s milk for 3 weeks and after that standard oral food challenge will be done again.
Main outcome variables
Permanent tolerance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181230042174N2
Registration date:2019-08-04, 1398/05/13
Registration timing:prospective
Last update:2019-08-04, 1398/05/13
Update count:0
Registration date
2019-08-04, 1398/05/13
Registrant information
Name
morteza fallahpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 4933
Email address
fallahpour.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-08, 1398/05/17
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of specificity of Double Dose Oral Food Challenge in predicting of permanent tolerance development in patient with history of anaphylaxis to cows milk under subject of desensitization
Public title
The assessment of ability of Double Dose Oral Food Challenge in predicting the permanent tolerance development in patient with history of anaphylaxis to cows milk under subject of desensitization
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
History of anaphylaxis to cows milk protein
at least 24 months post desensitization
symptom free within last 3 months
consent to project
Exclusion criteria:
every body who has not fulfill inclusion criteria
not full adherence to protocol of this study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
22
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 Iran university of medical science
Specific IgE & IgG4 , prick and prick to prick and Double Dose Oral food challenge test, then all of them will be strict avoided of cow`s milk for 3 weeks and after that standard oral food challenge will be done again.
Intervention groups
1
Description
there is no control group. all the permanent patients with anaphylaxis to cows milk whom underwent desensitization and eligible inaccording to inclusion criteria, will be assessed by: assessment of Specific IgE & IgG4 , prick and prick to prick and Double Dose Oral food challenge test, then all of them will be strict avoided of cow`s milk for 3 weeks and after that standard oral food challenge will be done again. at first 2 cc of blood serum will be stored at -21 c freezer and after finishing the sampling they will be assessed with immuno-CAP for sIgE & sIgG4. in the next step skin prick test with Greer allergy extracts and and prick to prick test with fresh milk will be done. oral food challenge will done with 8 gram protein equal with 72 g aptamil formula with cow`s milk base in 100 cc water( recommended daily dose in desensitization period was 4 g protein equal to 36g aptamil powder in 100 cc water). liquid will be use each 20 minutes with amount of:1,4,10,20,25 and 25 ml, then all the patients will be avoided of cow`s milk for 3 weeks and after that standard OFC will be repeated with 4 g protein in 100 cc .individuals who passed the second OFC will be considered permanent tolerance. all the data will analyses.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
rasool akram allergy clinic
Full name of responsible person
Fatemeh Alizadeh
Street address
niyayesh Ave. rasool akram hospital
City
tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6435 2241
Email
alizadeh.135@gmail.com
Web page address
http://hrmc.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Morteza Naserbakht
Street address
East Hemmat Highway. Iran Medical University
City
tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6435 2241
Email
alizadeh.135@gmail.com
Web page address
http://hrmc.iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?