Evaluation the effect of probiotic supplementation on clinical symptoms and biochemical indices in children with drug-resistant epilepsy
Design
Non-randomized clinical trial without control group
Settings and conduct
This study will be done on epileptic children who had been on adequate anticonvulsant medication for more than one year but their seizures was not stopped. First the patient's seizure will be recorded for one month .Then probiotics will be given for two months. Blood parameters and seizure parameters will be compared before and after. The study site will be Shahid Beheshti Hospital in Kashan.
Participants/Inclusion and exclusion criteria
Treatment-resistant epileptic patients under the age of 16 with no history of underlying and progressive brain disease.
Intervention groups
Resistant epileptic patients receiving probiotic
The intervention group is a group of resistant epilepsy patients who receive one capsule of prokid for 2 months as daily and the results are compared before and after.
Main outcome variables
Seizure frequency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170615034549N2
Registration date:2020-06-17, 1399/03/28
Registration timing:registered_while_recruiting
Last update:2020-06-17, 1399/03/28
Update count:0
Registration date
2020-06-17, 1399/03/28
Registrant information
Name
Mahmoud Salami
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5562 1157
Email address
salami-m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-27, 1398/08/05
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of probiotic supplementation on clinical symptoms and biochemical indices in children with drug-resistant epilepsy
Public title
Evaluation the effect of probiotic on drug-resistant epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a diagnosis of refractory epilepsy.
Patients are between 3 and 15 years old.
children who have a medical record with a medical doctor and have been referred to the pediatric neurosurgery clinic of Shahid Beheshti Hospital for treatment.
They have had at least one seizure in the past three months.
Exclusion criteria:
Children that the cause of their seizures are secondary such as electrolyte imbalances
Children with underlying, genetic or progressive brain diseases.
Children who have had probiotic use for one month before the study.
Children who take antibiotics with any reason for one month before the study.
Children who take any immunosuppressant medication with any reason for one month before the study.
Children who take any vitamin or mineral supplement except vitamin D
Age
From 3 years old to 15 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Kashan University of Medical Sciences
Street address
Physiology Research Center, Institute of Basic Sciences, Kashan University of Medical Sciences, Kashan, I. R. Iran
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2019-10-27, 1398/08/05
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1398.076
Health conditions studied
1
Description of health condition studied
Drug resistant epilepsy
ICD-10 code
G40
ICD-10 code description
Epilepsy and recurrent seizure
Primary outcomes
1
Description
Seizure frequency
Timepoint
before and after probiotic treatment
Method of measurement
asking frequency of seizure frequency
Secondary outcomes
1
Description
blood indices(Sodium- calcium - potassium - magnesium - hepatic enzymes including alkaline phosphatase, AST and ALT- bilirubin - creatinin)
Timepoint
before and after
Method of measurement
Measurement of venous blood sample
Intervention groups
1
Description
Intervention group: children with Drug resistant epilepsy that are received oral probiotic supplementation as daily with 2 month. The probiotic supplement is Prokid from Gostaresh Milad Farmed Co., which contains beneficial bacteria ,Bifidobacterium lactis, Lactobacillus acidophilus, Bifidobacterium bifidum, Lactobacillus rhamnos with 6×109 CFU concentration.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital of Kashan
Full name of responsible person
Dr. Ahmad Talebian
Street address
Ghotb Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973447
Phone
+98 31 5554 0027
Email
talebian_a@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Deputy of Research- Kashan University of Medical Sciences
Street address
Ghotb Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr Ahmad Talebian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ghotb Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973447
Phone
+98 31 5554 0027
Email
talebian_a@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahmoud Salami
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Ghotb ravandi Blvd
City
kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5562 1157
Email
salami-m@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fatemeh Zarei
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
Ghotb ravandi Blvd
City
kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5562 1157
Email
fa.zarei2631@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Publishing results as a paper
When the data will become available and for how long
permanently as a paper
To whom data/document is available
All people
Under which criteria data/document could be used
For research and therapeutic aims (if possible)
From where data/document is obtainable
Dr. Salami
What processes are involved for a request to access data/document