The effect of synbiotics on children with drug-resistant epilepsy in children referred to the clinics of Arak University of Medical Sciences and the quality of life of their caregivers
Determining the effect of synbiotic supplementation on the number of epileptic seizures in children with refractory epilepsy and the quality of life of caregivers
Design
This before and after clinical trial was performed on 30 children with refractory seizures.
We do not have blindness in this study and the study will be done Open-Labled. The effect of synbiotics in a group will be examined before and after, so randomization is not and will not be done.
Settings and conduct
This before and after clinical trial will be performed on 30 children with refractory seizures referred to the clinics of Arak University of Medical Sciences in 2021, which has been diagnosed by a pediatric neurologist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age group 1 year to 15 years old; having at least one seizure per month despite the use of anticonvulsant drugs in the last three months; no history of hypertension; no active infection; no history of gastrointestinal ulcers; minimal consumption Anticonvulsant drug as a single drug with appropriate amount and duration (at least 2 months) and lack of seizure control. Exclusion criteria: infants with infantile spasm; recent history of false seizures; active infection; history of hypertension; history of gastrointestinal tract ulcers; patients who terminate the treatment plan earlier than scheduled due to personal reasons and lack of necessary cooperation and communication.
Intervention groups
For previous anticonvulsant medications, the infant should use paddy lactate at a dose of 5 to 15 drops per day for 8 weeks daily, and children 2 to 15 years old should take Kidi lactate at a dose of 1 sachet per day for 8 weeks daily for up to one month.
Main outcome variables
Number of epileptic seizures; quality of life caregivers; seizure onset time; aura
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200519047517N1
Registration date:2021-10-11, 1400/07/19
Registration timing:registered_while_recruiting
Last update:2021-10-11, 1400/07/19
Update count:0
Registration date
2021-10-11, 1400/07/19
Registrant information
Name
amirali mottaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3464
Email address
md.mottaghi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of synbiotics on children with drug-resistant epilepsy in children referred to the clinics of Arak University of Medical Sciences and the quality of life of their caregivers
Public title
Evaluation of the effect of probiotics in resistant pediatric epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 1 year to 15 years
Having at least one seizure a month despite using anticonvulsants for the past three months
Taking at least 3 anticonvulsant drugs as a single drug with appropriate amount and duration (at least 2 months) and lack of seizure control
No history of hypertension
Absence of active infection
No history of gastrointestinal ulcers
Exclusion criteria:
Infants with infantile spasm
Recent history of pseudo-seizures
Active infection
History of hypertension
History of gastrointestinal ulcers in patients
Patients who terminated the treatment plan earlier than scheduled due to personal reasons, lack of necessary cooperation and communication.
Age
From 1 year old to 15 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
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 Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Sardasht
City
Arak
Province
Markazi
Postal code
3848176589
Approval date
2021-06-27, 1400/04/06
Ethics committee reference number
IR.ARAKMU.REC.1400.077
Health conditions studied
1
Description of health condition studied
Resistant epilepsy
ICD-10 code
G40.1
ICD-10 code description
Other generalized epilepsy and epileptic syndromes, not intractable, with status epilepticus
Primary outcomes
1
Description
Number of epileptic seizures per month
Timepoint
One Month
Method of measurement
The ZARIT burden questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
To previous anticonvulsant drugs, the infant patient should use Pedi Lactic 5 to 15 drops per day for 8 weeks daily and children 2 to 15 years old should take Kidi Lactic 1 sachet per day for 8 weeks daily for up to one month. synbiotics will be used by Bio Fermentation Company made in Iran.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Amirali Mottaghi
Street address
Alamolhoda Blvd., Arak Town
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
elamirali313@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Aalireza Kamali
Street address
Arak University of Medical Sciences, Sardasht Ave.
City
Arak
Province
Markazi
Postal code
3848175593
Phone
+98 86 3417 3502
Email
amozesh@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Fakhreddin Shariatmadari
Position
Associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Amirkabir Hospital, Khorram Ave.
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3502
Email
shariat.8666@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fakhreddin Shariatmadari
Position
associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Amirkabir Hospital, Khorram ave.
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3502
Email
shariat.8666@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fakhredin Shariatmadari
Position
associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Amirkabir Hospital, Khorram Ave.
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3502
Email
shariat.8666@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
After identifying people, it is shared
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
researchers
Under which criteria data/document could be used
Citation of data is unrestricted
From where data/document is obtainable
Email responsible for the plan
What processes are involved for a request to access data/document
After checking the accuracy of the information in the applicant