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Evaluation of co-amoxiclav on seizure frequency in drug-resistant epilepsy in children

Protocol summary

Study aim
Determining the effect of coamoxiclav drug on the frequency of seizures in children with drug-resistant epilepsy
Design
A controlled, unblinded, phase 2 clinical trial on 20 patients
Settings and conduct
This study was designed as a non-blind clinical trial on children with drug-resistant epilepsy referred to the clinic of Bo Ali Sina Hospital in Sari in 2022. In this study, the first stool sample is taken from 20 patients after the initial interview. And the second stool sample is taken after a 5-day period of Amoxiclav drug consumption, 5-7 days apart from the first sample. Also, 9 healthy children are sampled once. Stool samples are collected and stored in special containers in a freezer at -20 until specialized tests are performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children aged 3-18 years who had an established diagnosis of drug-resistant epilepsy, and had two or more seizures during a week. Consent of the patient or his/her guardian. The exclusion criteria: History of penicillin allergy, patients treated with co-amoxiclav interfering drugs, reception of corticosteroids, taking antibiotics in the last 1 month or needing to take another antibiotic during the study period, liver disease, patients who are candidates for epilepsy surgery or other non-pharmacological methods, and need to change the dose of anticonvulsant during the study period.
Intervention groups
In this study, the first stool sample was taken from 20 patients. And the second stool sample was taken after a 5-day period of taking Amoxiclav, 5-7 days apart from the first sample. Also, 9 healthy children were sampled once.
Main outcome variables
Evaluating the frequency of seizures in patients with drug-resistant epilepsy before and after receiving coamoxiclav, investigating changes in intestinal microbes in patients with drug-resistant epilepsy before and after receiving coamoxiclav

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20090412001808N8
Registration date: 2024-01-29, 1402/11/09
Registration timing: retrospective

Last update: 2024-01-29, 1402/11/09
Update count: 0
Registration date
2024-01-29, 1402/11/09
Registrant information
Name
Ali Abbaskhanian
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1223 3010
Email address
aabbaskhanian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
2022-06-25, 1401/04/04
Actual recruitment end date
2023-09-22, 1402/06/31
Trial completion date
2023-09-22, 1402/06/31
Scientific title
Evaluation of co-amoxiclav on seizure frequency in drug-resistant epilepsy in children
Public title
Evaluation of co-amoxiclav on seizure frequency in drug-resistant epilepsy in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 3-18 years An established diagnosis of drug-resistant epilepsy with two or more seizures during the 7-day baseline period Consent of the patient or the patient's guardian to participate in the study
Exclusion criteria:
History of penicillin allergy Patients treated with co-amoxiclav interfering drugs reception of corticosteroids Taking antibiotics in the last 1 month or needing to take another antibiotic during the study period Liver disease Patients who were candidates for epilepsy surgery or other non-pharmacological methods Patients who need to change the dose of anticonvulsant during the study period
Age
From 3 years old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 25
Actual sample size reached: 20
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 the Mazandaran University of Medical Sciences
Street address
Research and Technology Deputy Building., Moalem Square
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Approval date
2020-06-21, 1399/04/01
Ethics committee reference number
IR.MAZUMS.REC.1399.5208

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
The primary laboratory outcome is defined as changes in the microbial load of different species in stool samples on the fifth day compared to baseline.
Timepoint
The first stool sample is taken from patients after the initial interview. The second stool sample is taken after 5 days of taking co-amoxiclav, 5-7 days apart from the first sample.
Method of measurement
Bacterial copy number is determined in patients' feces samples using real-time PCR technique.

2

Description
The primary clinical outcome is response rate at week 12. A response rate of ≥50% reduction in seizures is classified as "responder" and less than 50% reduction in seizure frequency is classified as "non-responder".
Timepoint
The patient and his/her family are asked to record the frequency of seizures up to 12 weeks after receiving the drug.
Method of measurement
Self report

Secondary outcomes

empty

Intervention groups

1

Description
Administer coamoxiclav at a dose of 40 mg/kg/d in two divided doses for 5 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Boo'Ali Sina Hospital
Full name of responsible person
Ali Abaskhanian
Street address
Boo'Ali Sina Hospital, Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۸۳۸۴۷۷
Phone
+98 11 3334 3010
Fax
Email
aabbaskhanian@mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ali Abaskhanian
Street address
Mazandaran University of Medical Sciences, Valie-Asr Boulevard, Sari, Mazandaran
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3304 4000
Email
info@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Ali Abaskhanian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Boo'Ali Sina Hospital, Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۸۳۸۴۷۷
Phone
+98 11 3334 3010
Email
aabbaskhanian@mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ali Abaskhanian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Boo'Ali Sina Hospital., Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۸۳۸۴۷۷
Phone
+98 11 3334 3010
Email
aabbaskhanian@mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Kobra Sheidaee
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Boo'Ali Sina Hospital., Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۸۳۸۴۷۷
Phone
+98 11 3334 3010
Email
azadehsheidaee@gmail.com

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
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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