determine the effect of desensitization in patients with sesame anaphylaxis
Design
According to the notification to allergist specialists,patients referred to our clinic & samples are selected sequentially among them.the sample size is estimated 10
Settings and conduct
oral immunotherapy in two phases:induction phase(with injection of two doses of omalizumab) in 4weeks with weekly incremental increase of sesame according to protocol until reaching to target dose of 5 gram of sesame protein in Rasool hospital allergy clinic & continued target dose at home for 4 months in maintenance phase
Participants/Inclusion and exclusion criteria
Inclusion criteria:positive oral food challenge with sesame tahini in patients with sesame anaphylaxis history with or without positive skin prick,skin prick to prick or specific IgE sesame tests.
Exclusion criteria:
1.age less than 4 years 2.history of cardiovascular disease
3.beta blocker or ACEI drug usage
4.severe or uncontrolled asthma
5.infectious or immune deficiency disease
6.unwillingness of patient
Intervention groups
Initially,OFC will be done to confirmation of diagnosis in all patients.the patients with positive OFC are selected for treatment.Immunotherapy has two phases.induction phase in 4weeks with weekly incremental increase of sesame.in second phase(maintenance) patients continue to cosume target dose at home for 4 months .At the end of the fourth month to determine of success of desensitization,OFC will done again.
Main outcome variables
desensitization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181002041210N1
Registration date:2018-10-18, 1397/07/26
Registration timing:registered_while_recruiting
Last update:2018-10-18, 1397/07/26
Update count:0
Registration date
2018-10-18, 1397/07/26
Registrant information
Name
Fereshteh Salari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2383
Email address
drfereshtehsalari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of sesame oral immunotherapy effect for desensitization in patients with sesame anaphylaxis
Public title
Evaluation of desensitization in patients with sesame anaphylaxis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
positive oral food challenge with consumption of sesame tahini(OGHAB HALVA company) in patient with sesame anaphylaxis history with or without positive skin prick,skin prick to prick or specific IgE sesame tests
Exclusion criteria:
age less than 4 years
history of cardiovascular disease
beta blocker or ACEI drug usage
severe or uncontrolled asthma
infectious or immune deficiency disease
unwillingness of patient
Age
From 4 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
10
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 Sciences
Street address
Iran University of Medical Sciences,Near the Milad Tower,Hemmat Highway,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-03-07, 1396/12/16
Ethics committee reference number
IR.IUMS.FMD.REC1396.9511568001
Health conditions studied
1
Description of health condition studied
sesame anaphylaxis
ICD-10 code
T78
ICD-10 code description
Anaphylactic shock due to adverse food reaction
Primary outcomes
1
Description
sesame anaphylaxis in oral food challenge
Timepoint
ٍEvaluation of sesame anaphylaxis in the begining of the study(before intervention) and 4 months after the end of immunotherapy
Method of measurement
oral food challenge test
Secondary outcomes
1
Description
serum specific sesame immunoglobulin E level
Timepoint
in the begining of the study(before intervention) and 4 months after the end of immunotherapy
Method of measurement
ImmunoCAP specific IgE test
2
Description
size of wheal in skin prick test
Timepoint
in the begining of the study(before intervention) and 4 months after the end of immunotherapy
Method of measurement
ruler
3
Description
size of wheal in skin prick to prick test
Timepoint
in the begining of the study(before intervention) and 4 months after the end of immunotherapy
Method of measurement
ruler
Intervention groups
1
Description
Intervention group:at first all patients receive two doses of omalizumaboral (anti IgE antibody)150 mg by subcutaneous injection 4 weeks before starting treatment and second dose at the begining of the immunotherapy.Immunotherapy in two phases:induction phase in 4weeks with weekly incremental increase of sesame tahini(OGHAB HALVA company) according to protocol until reaching to target dose of 5 gram of sesame protein in Rasool hospital allergy clinic & continued daily cosumption of target dose at home for 4 months in maintenance phase.during the study daily telephone followup calls for patients will be done.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
ّFereshteh Salari
Street address
Niayesh Ave,Satarkhan Ave
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2383
Email
drfereshtehsalari@gmail.com
Web page address
http://hrmc.iums.ac.ir/index.php
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fereshteh Salari
Street address
Iran University of Medical Sciences,Near the Milad Tower,Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
PR@iums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Iran University of Medical Sciences
Full name of responsible person
Fereshteh Salari
Position
Fellowship of allergy & clinical immunology
Latest degree
Specialist
Other areas of specialty/work
allergy & clinical immunology
Street address
clinic of Allergy,Hazrat Rasool Akram Hospital,Niayesh Ave,Satarkhan Ave