Determination of the effect of oral immunotherapy of nuts in the treatment of patients with type 1 allergy after eating nuts
Design
Randomized clinical trial
Settings and conduct
patients are subjected to immunotherapy. Desensitization is done for different people for four types of nuts: walnut, pistachio, hazelnut and almond. Depending on the severity of the reaction, each person is first given nuts that they are sensitive to from one hundredth to one thousandth of the desired. Then the person visits once a week and the dose is gradually increased according to the prepared protocol up to the maximum target amount within 4 to 6 months. The goal is that at the end of the follow-ups, the person can consume 3 grams of protein from those nuts without having a type 1 allergic reaction. Further, after 4 to 6 months of treatment, when the amount consumed reaches 3 grams of protein, the process of increasing the dose is stopped.
Rasool-E-Akram hospital - Tehran
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with type 1 allergy after eating nuts referred to Rasool Akram Hospital
Exclusion criteria:
1. Patients with cardiovascular diseases, diabetes
2. Patients with skin symptoms of chronic eczema or active allergic diseases such as asthma, allergic rhinitis and uncontrolled active atopic dermatitis
Intervention groups
Patients with type 1 allergy after eating nuts referred to Rasool Akram Hospital.
Each person is given from one hundredth to one thousandth of the desired nuts to which he is sensitive.
Main outcome variables
Allergy symptoms - CRD test (Component-resolved diagnosis) - Skin prick test - Specific antibody test (sIegE) - Total IgE
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240121060754N1
Registration date:2024-05-06, 1403/02/17
Registration timing:retrospective
Last update:2024-05-06, 1403/02/17
Update count:0
Registration date
2024-05-06, 1403/02/17
Registrant information
Name
seyede samane asefi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 1000
Email address
asefi_samane@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-03-18, 1402/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of the effect of oral immunotherapy of nuts in the treatment of patients with type 1 allergy after eating nuts
Public title
Effect of oral immunotherapy of nuts in the treatment of type 1 allergy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 1 allergy after eating nuts
Exclusion criteria:
Patients with cardiovascular diseases, diabetes
Patients with skin symptoms of chronic eczema or active allergic diseases such as asthma, allergic rhinitis and uncontrolled active atopic dermatitis
Age
From 4 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
One week after the last re-dose, prick test and sIgE and Total IgE are done for the patient.
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
Research Ethics Committees of School of Medicine, Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2023-04-26, 1402/02/06
Ethics committee reference number
IR.IUMS.FMD.REC.1402.043
Health conditions studied
1
Description of health condition studied
Type 1 allergy with food
ICD-10 code
L27.2
ICD-10 code description
Dermatitis due to ingested food
Primary outcomes
1
Description
Allergy symptoms
Timepoint
first visit - 4 to 6 months after treatment
Method of measurement
Questionnaire and visit
2
Description
CRD test (Component-resolved diagnosis)
Timepoint
first visit - 4 to 6 months after treatment
Method of measurement
Questionnaire and visit
3
Description
Skin prick test
Timepoint
first visit - 4 to 6 months after treatment
Method of measurement
Questionnaire and visit
4
Description
Specific antibody test (sIegE)
Timepoint
first visit - 4 to 6 months after treatment
Method of measurement
Questionnaire and visit
5
Description
Total IgE
Timepoint
first visit - 4 to 6 months after treatment
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients are subjected to immunotherapy. Desensitization is done for different people for four types of nuts: walnut, pistachio, hazelnut and almond. Depending on the severity of the reaction, each person is first given nuts that they are sensitive to from one hundredth to one thousandth of the desired. Then the person visits once a week and the dose is gradually increased according to the prepared protocol up to the maximum target amount within 4 to 6 months. The goal is that at the end of the follow-ups, the person can consume 3 grams of protein from those nuts without having a type 1 allergic reaction. Further, after 4 to 6 months of treatment, when the amount consumed reaches 3 grams of protein, the process of increasing the dose is stopped.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool-E-Akram hospital
Full name of responsible person
Seyedeh Samaneh Asefi
Street address
Rasoul-E-Akram Hospital, Maziar Mansouri street, Sattarkhan street, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2528
Email
Asefi_samane@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Nabawi
Street address
Rasoul-E-Akram Hospital, Maziar Mansouri street, Sattarkhan street, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2528
Email
Asefi_samane@yahoo.com
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
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
Iran University of Medical Sciences
Full name of responsible person
Seyedeh Samaneh Asefi
Position
Medical resident
Latest degree
Specialist
Other areas of specialty/work
Immunology
Street address
Rasoul-E-Akram Hospital, Maziar Mansouri street, Sattarkhan street, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2528
Email
Asefi_samane@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyedeh Samaneh Asefi
Position
Medical resident
Latest degree
Specialist
Other areas of specialty/work
Immunology
Street address
Rasoul-E-Akram Hospital, Maziar Mansouri street, Sattarkhan street, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2528
Email
Asefi_samane@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyedeh Samaneh Asefi
Position
Medical resident
Latest degree
Specialist
Other areas of specialty/work
Immunology
Street address
Rasoul-E-Akram Hospital, Maziar Mansouri street, Sattarkhan street, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2528
Email
Asefi_samane@yahoo.com
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
All potential data can be shared after publication of result
When the data will become available and for how long
At the end of data collection period until the publication of results
To whom data/document is available
Only doctors and medical students
Under which criteria data/document could be used
Only when people intend to research about this topic
From where data/document is obtainable
To the scientific and executive members of the project
What processes are involved for a request to access data/document
Communicate with the scientific and executive authorities of the project - Submiting their official letter from research centers -using the patient's information only at designated center - Submiting their final report obtained by information.