Investigating the effect of GABA-producing probiotics on reducing seizures in patients with drug-resistant epilepsy.
Design
A superior two-arm clinical trial with parallel groups, incorporating a control group, double-blind, randomized, phase 3 on 70 patients. Randomization will be conducted using Stata software. The block randomization method is used to generate the random allocation sequence. Random blocks of sizes 4 and 6 are created through the website https://www.sealedenvelope.com/simple-randomiser/v1/lists.
Settings and conduct
Pediatric Neurology Clinic of Qaem Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients recognized as having drug-resistant epilepsy (having seizures despite taking more than two appropriate drugs for the type of seizure).
Exclusion criteria:
The cause of seizures being progressive brain diseases.
Gastrointestinal problems that interfere with the absorption of probiotics.
Patient's refusal to continue the research.
Occurrence of side effects including diarrhea, vomiting, skin rash, and exacerbation of seizures (which will be mentioned separately in the final statistics).
Intervention groups
Patients will be divided into two groups: one receiving routine treatment accompanied by probiotics, and the other receiving routine treatment along with a placebo (similarly packaged as the other groups but without probiotics or herbal substances).
Main outcome variables
The effect of the drug in reducing the number of seizures
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240408061452N1
Registration date:2024-05-09, 1403/02/20
Registration timing:registered_while_recruiting
Last update:2024-05-09, 1403/02/20
Update count:0
Registration date
2024-05-09, 1403/02/20
Registrant information
Name
shima shekari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2000
Email address
dr.shekari.shima@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of GABA-producing probiotic bacteria on decreasing seizures in children with refractory epilepsy
Public title
Effect of probiotic bacteria on decreasing seizures in children with refractory epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients known as drug-resistant epilepsy
having seizures despite taking more than two appropriate medications for the type of seizure
age between 4 to 16 years
Exclusion criteria:
The cause of the seizure may be progressive brain diseases.
digestive disorders which interfere probiotic absorption
incidence of complications including diarrhea, vomiting, rash
The patient's reluctance to continue participating in the study.
Age
From 4 years old to 16 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method is used to generate a sequence of random assignments.
Random blocks of variable sizes 4 and 6 are prepared via the website https://www.sealedenvelope.com/simple-randomiser/v1/lists.
The content of each block is sealed in an opaque envelope, and upon the patients' visits, one of the blocks is randomly selected. Depending on the sequence content, the individual is placed in one of the study arms.
Blinding (investigator's opinion)
Double blinded
Blinding description
After the random allocation of each patient to the study groups, and the interventions performed by the researcher, the evaluation of patient outcomes will be conducted by a researcher who is unaware of the type of intervention received.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine- Mashhad University of Medical Sciences
Street address
Daneshgah
City
Mashhad
Province
Razavi Khorasan
Postal code
9188385656
Approval date
2023-11-07, 1402/08/16
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.423
Health conditions studied
1
Description of health condition studied
refractory or drug-resistant epilepsy
ICD-10 code
G40.9
ICD-10 code description
Epilepsy, unspecified
Primary outcomes
1
Description
seizure frequency
Timepoint
30 days
Method of measurement
numbering seizure frequency
Secondary outcomes
empty
Intervention groups
1
Description
The group receiving routine treatment along with a selected probiotic, chosen from strains of Lactobacillus brevis, Lactobacillus delbrueckii subsp. bulgaricus, and Lactobacillus plantarum sourced from the Iranian Industrial Microorganisms Collection Center with PTCC or ATCC designations, will be evaluated for their ability to produce gamma-aminobutyric acid (GABA) in MRS broth. The strain that demonstrates a higher capacity to produce GABA will be selected and prepared in a consumable powder form. The treatment period will last for 30 days with daily administration of the probiotic.
Category
Treatment - Drugs
2
Description
The recipient group will receive routine treatment along with placebo (packaged similarly to the intervention group but without probiotics). The treatment period will be for 30 days with daily medication administration.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Neurology Clinic of Qaem Hospital
Full name of responsible person
Mehran Beiraghi Toosi
Street address
Daneshgah
City
Mashhad
Province
Razavi Khorasan
Postal code
9188385656
Phone
+98 51 3800 2000
Email
beiraghitm@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mohsen tafaghodi
Street address
daneshgah
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
TafaghodiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Shima shekari
Position
felowship of Pediatric neurology
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
daneshgah
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
dr.shekari.shima@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shima Shekari
Position
Pediatric neurology felowship
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Daneshgah
City
Mashhad
Province
Razavi Khorasan
Postal code
9188385656
Phone
+98 51 3800 2000
Fax
Email
dr.shekari.shima@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shima Shekari
Position
Pediatric neurology felowship
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Daneshgah
City
Mashhad
Province
Razavi Khorasan
Postal code
9188385656
Phone
+98 51 3800 2000
Fax
Email
dr.shekari.shima@gmail.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
No - There is not 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
data will be available upon resonable request from corresponding
When the data will become available and for how long
6 months after publishing results
To whom data/document is available
resheachers
Under which criteria data/document could be used
using in other research
From where data/document is obtainable
correspond, Dr. mehran beiraghi toosi
What processes are involved for a request to access data/document