Evaluation of Relationship between Food Allergy and Refractory Seizures in Children
Design
In Shis study 34 Patients with Inclusion Criteria referred to Neurologic Clinic and no response to Opimal anti epileptic drugs came to allergy clinic; each of Patient had a Specific Code
Settings and conduct
This Study was conducted Clinical Trial.34 Patients with Inclusion Criteria referred to Neurologic Clinic and no Response to Opimal Anti epileptic Drugs came to Allergy Clinic; Demographic Data, the Daily Seizures Frequency, Eosinophilia, Serum IgE, Type of Seizure, MRI and EEG and Skin Prick Tests finding with Indoor, Outdoor and Food Allergens of Patients entered in Forms.Before and After 8-weeks Food avoidance with 6 Main Food, Daily Seizures Frequency was recorded in the Patient Information Form.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
The Patients Should have Refractory Idoipatic Seizures.
Minimum Age is 1 month and Maximum Age is 16 years
Exclusion Criteria:
Not able to do food avoidance
Certain Cause for Seizure like Cerebral Palsy
Intervention groups
34 Patients 1month to 16 years old with Refractory Seizures referred to Neurologic Clinic and no Response to Optimal anti Epileptic Drugs came to Allergy Clinic
Skin Prick Tests Finding with Indoor, Outdoor and Food Allergens of Patients entered in Forms.
Main outcome variables
Reduction in Seizure Frequency
Food Regimen Tolerance
Lack of Complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171022036925N2
Registration date:2018-03-10, 1396/12/19
Registration timing:retrospective
Last update:2018-03-10, 1396/12/19
Update count:0
Registration date
2018-03-10, 1396/12/19
Registrant information
Name
Hoshng Gorjipour
Name of organization / entity
Mofid children’s hospital
Country
Iran (Islamic Republic of)
Phone
+98 22227021
Email address
info-mch@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Children neurologic research center
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
2016-07-22, 1395/05/01
Actual recruitment end date
2017-03-18, 1395/12/28
Trial completion date
empty
Scientific title
The Evaluation of Relationship between Food Allergy and Refractory Seizures in Children
Public title
Food Allergy and Refractory Seizures in Children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The Patients Should have Refractory Idoipatic Seizures
Minimum Age is 1 month and Maximum age is16 years
Exclusion criteria:
Not able to do Food Avoidance
There was certain cause for Seizure such as Cerebral Palsy
Age less than 1 month and more than 16 years
Age
From 1 month old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
36
Actual sample size reached:
34
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
In this study 34 patients 1 month to 16 years old with refractory seizures referred to neurologic clinic that received optimal epilepsy drugs came to our allergy clinic for this intervention
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Velenjak-University Bulvar
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2016-05-29, 1395/03/09
Ethics committee reference number
IR.SBMU.RETECH.REC.1395.167
2
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Velenjak-University Bulvar
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2016-05-29, 1395/03/09
Ethics committee reference number
IR.SBMU.RETECH.REC.1395.167
Health conditions studied
1
Description of health condition studied
Refractory Seizures
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Seizure
Timepoint
Before and 8 Weeke After Intervention
Method of measurement
Seizure Frequency in Day-Week and Month
Secondary outcomes
1
Description
Seizure Frequency
Timepoint
Daily-Weeky-Monthly
Method of measurement
Seizure Frequency in Day-Week-Month
Intervention groups
1
Description
Six Main Food Avoidance((Milk-Egg-Peanut-Wheat-Soya-Sea Food1-Six Main Food Avoidance(Milk- Egg-Peanut-Wheat-Soya-Sea Food)2-Use Neocate Formula or Elemental Base Formula
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid Children’s Hospital
Full name of responsible person
Hoshang Gorjipour
Street address
Shareeati Street, Near to Mirdamad
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2222 7021
Email
info-mch@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pediatric Neurologic Research Center
Full name of responsible person
Dr Mohammad Ghofrani
Street address
Mofid Children’s Hospital
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2290 9559
Email
pnr.center@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pediatric Neurologic Research Center
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
Mofid Children’s Hospital
Full name of responsible person
Hoshang Gorjipour
Position
Fellow of Immunology and Allergy
Latest degree
Subspecialist
Other areas of specialty/work
Street address
Mofid’s Hospital
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2284 4186
Fax
Email
dr.hgorjipour@ymail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mofid Children’s Hospital
Full name of responsible person
Dr Mahbubeh Mansoori
Position
Immunologist and Allergist
Latest degree
Subspecialist
Other areas of specialty/work
Street address
Mofid’s Hospital
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2222 7021
Fax
Email
mbmans65@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mofid Children’s Hospital
Full name of responsible person
Hoshang Gorjipour
Position
Fellow of Immunology and Allergy
Latest degree
Subspecialist
Other areas of specialty/work
Street address
Shareeati Street, Near to Mirdamad
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
00
Fax
Email
dr.hgorjipour@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
After Registration in Validate Journals
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available