Evaluation of double dose wheat tolerance, serum and dermatologic marker changes in prediction of permanent tolerance in patients with wheat anaphylaxis under oral desensitization.
Tolerance of double maintenance dose and changes in serum and dermal markers in the prediction of permanent tolerance in anaphylaxis to wheat in patient has undergone oral desensitization
Design
This is a Internationale pilot study on 20 people who are at least 1 year in maintenance phase of desensitization to wheat
Settings and conduct
predictors of tolerance including consumption of double maintenance phase dose of wheat and serum igE and igG4 levels in individuals who have been exposed to wheat for at least 1 year in the maintenance phase of desensitization and whose persistent tolerance is proven by double blind methods
Participants/Inclusion and exclusion criteria
All patients with a history of type 1 or anaphylaxis respond to wheat that are under immunotherapy and
1. At least 1 year are treated with maintenance phase
2,At last for 3 months there is no type 1 allergic reaction
3. Do not discontinue the maintenance regimen
Exit criteria:
1. Serum before immunotherapy is not available
2 - The prick test has not been performed before immunotherapy
3. Patient has no satisfaction to test
Intervention groups
Individuals who have undergone desensitization to wheat and now they are in maintenance phase at least for 1 year
Main outcome variables
Independent Variables:changes in serum igE; changes in serum IgG4; variations in the diameter of the skin prick test;tolarance of double dose wheat
Dependent variable:permanent tolerance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190612043872N1
Registration date:2019-07-08, 1398/04/17
Registration timing:registered_while_recruiting
Last update:2019-07-08, 1398/04/17
Update count:0
Registration date
2019-07-08, 1398/04/17
Registrant information
Name
Ali Pourvali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8824 5435
Email address
pourvali.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-06, 1398/04/15
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of double dose wheat tolerance, serum and dermatologic marker changes in prediction of permanent tolerance in patients with wheat anaphylaxis under oral desensitization.
Public title
ٍEvaluation of the relationship between anaphylaxis recovery to wheat with tolerance of higher wheat consumption and serum and skin changes in patients undergoing desensitization
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with a history of type 1allergy or anaphylaxis to wheat undergoing at least 1 year of maintenance immunotherapy
Exclusion criteria:
The maintenance diet has been discontinued
For the last 3 months, there is a type 1 allergic reaction
Serum before immunotherapy is not available
Age
From 3 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In the final challenge of tolerance to wheat, both the participant and clinical caregivers are blind.
Placebo
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