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Evaluation of probiotics effect on quality of life and seizure attacks in patients with refractory epilepsy in pediatric neurology clinics of Urmia University of Medical Sciences

Protocol summary

Study aim
etermining the effect of Reuteflor probiotic on the quality of life and reduction of seizures in treatment-resistant epilepsy patients in pediatric neurology clinics of Urmia University of Medical Sciences.
Design
The samples under investigation in the present study are 75 children with epilepsy resistant to treatment with an age range of 3 to 18 years old that referred to pediatric clinics of Urmia University of Medical Sciences, who were selected consecutively and available according to the inclusion criteria
Settings and conduct
The present study is an intervention study of before and after type. The place of study is pediatric neurology clinics of Urmia University of Medical Sciences
Participants/Inclusion and exclusion criteria
The criteria for inclusion in the study were all drug-resistant epilepsy patients between the ages of 3 and 18 year old. Exclusion criteria : the development of serious complications following the use of drugs, lack of satisfaction with the continuation of the study, Non-epileptic seizures, change in the dose and type of anti-epileptic drugs in the last 30 days, probiotic consumption in the last 30 days, insufficiency Renal or hepatic, lactose intolerance, celiac disease, long-term antibiotic use and life expectancy of less than 1 year, as well as the presence of progressive neurodegenerative disease, the presence of any psychiatric disorder, and the receipt of relevant drugs according to the parents' opinion.
Intervention groups
In the present study, the intervention is the prescription of probiotic medicine. The probiotic under investigation, is Reuteflor that contains lyophilized lactobacillus reuteri bacteria with a daily dose of one sachet will be given.
Main outcome variables
The average number of convulsions of patients with resistant epilepsy 3 months after the start of probiotic and before the start of the intervention is different.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221024056286N1
Registration date: 2022-12-21, 1401/09/30
Registration timing: prospective

Last update: 2022-12-21, 1401/09/30
Update count: 0
Registration date
2022-12-21, 1401/09/30
Registrant information
Name
Parisa Alaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3343 8795
Email address
hamed.nodet@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of probiotics effect on quality of life and seizure attacks in patients with refractory epilepsy in pediatric neurology clinics of Urmia University of Medical Sciences
Public title
Evaluation of probiotics effect on quality of life and seizure attacks in patients with refractory epilepsy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patients with refractory epilepsy
Exclusion criteria:
Cause serious complications following drug use Dissatisfaction with continuing the study Non-epileptic seizures History of status epilepticus in the last 12 months Change in dose and type of antiepileptic drugs in the last 30 days Probiotic consumption in the last 30 days Chronic GI diseases, kidney or liver failure lactose intolerance Life expectancy less than 1 year Presence of progressive neurodegenerative disease Presence of any psychiatric disorder
Age
From 3 years old to 18 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 75
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
Ethics committee of Urmia University of Medical Sciences
Street address
no 10 . 37 ave Beheshti blv
City
Urmia
Province
West Azarbaijan
Postal code
5715844331
Approval date
2021-08-11, 1400/05/20
Ethics committee reference number
IR.UMSU.REC.1400.195

Health conditions studied

1

Description of health condition studied
epilepsy
ICD-10 code
G40
ICD-10 code description
Epilepsy and recurrent seizures

Primary outcomes

1

Description
Quality of life score in Quality of Life in Childhood Epilepsy Questionnaire version 55
Timepoint
3 months before and 3 month later
Method of measurement
Quality of life score in Quality of Life in Childhood Epilepsy Questionnaire version 55

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Administration of Reuteflor probiotic which contains 300 miligram lyophilized live friendly bacteria , Lactobacillus reuteri , once per day dose that dissolve in cool water or food . it manufactured in Fara Daru company .
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahari Hospital
Full name of responsible person
Parisa Alaie
Street address
Motahari Hospital , Kashani Ave
City
Urmia
Province
West Azarbaijan
Postal code
5714755241
Phone
+98 44 3223 7077
Email
motahari-h-urm@umsu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Ghazavi Ahad
Street address
Urgency Ave , Resalat ST
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
umsu@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Parisa Alaie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No 1 , 37th Ave , Beheshti Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5715822334
Phone
+98 44 3343 8795
Email
hamed.nodet@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Parisa Alaie
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
10 Apartment No 1 37 Ave Shahid beheshti st.
City
Urmia
Province
West Azarbaijan
Postal code
5715833443
Phone
+98 44 3343 8795
Fax
Email
Hamed.nodet@gnail.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Parisa Alaie
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
10 Apartment No 1 37 Ave Shahid beheshti st.
City
Urmia
Province
West Azarbaijan
Postal code
5715833443
Phone
+98 44 3343 8795
Fax
Email
Hamed.nodet@gnail.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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
After Unrecognize the patients , age , sex , seizure type , Cerebral palsy , seizure frequency , drugs and quality of life will share.
When the data will become available and for how long
sharing will begin 6 month after result printing
To whom data/document is available
expose to all
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
Parisa Alaie , Call 00989149773819
What processes are involved for a request to access data/document
There is no special process and it will be accessed in the shortest time
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