Back to resultsCiprofloxacin in Drug-resistant Epilepsy (CIDRE)
Primary Purpose
Epilepsy Intractable
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Ciprofloxacin Oral Product
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy Intractable
Eligibility Criteria
Inclusion Criteria:
- Drug-resistant epilepsy with frequency of at least 2 seizure/Week
- Acceptance of patients or his/her guardian (Signing informed consent)
Exclusion Criteria:
- Hypersensitivity to ciprofloxacin or other fluoroquinolones
- History of tendon, renal, hepatic or cerebrovascular disease, organ transplantation or myasthenia gravis
- Usage of medications with interaction to ciprofloxacin
- No reliable contraception
- Pregnancy or breastfeeding
- Being under treatment with corticosteroid
- Usage of antibiotics in recent 2 months or need to use it during the study
- Patients who are candidate for epilepsy surgery or other nonmedical treatments
- Change in anti-seizure medications (ASMs) during recent month
- Patients who will need changes in ASMs dose during study
Sites / Locations
- Bu Ali Sina hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Ciprofloxacin
Arm Description
Outcomes
Primary Outcome Measures
Changes in seizure frequency registered in questionnaire
Comparison of seizure frequency in 4th week with the frequency at the start of the study.
Changes in quantity of microbial DNA extracted from stool samples by AccuPrep Stool DNA extraction Kit
Comparison of quantity of extracted microbial DNA in stool sample taken at day5-7 with the sample taken at the start of the study
Changes in microbial burden of stool samples using Absolute real time polymerase chain reaction (PCR)
Comparison of microbial burden of stool samples taken at day5-7 with the sample taken at the start of the study
Secondary Outcome Measures
Changes in seizure frequency registered in questionnaire
Comparison of seizure frequency in 12th week with the frequency at the start of the study
Full Information
NCT ID
NCT04763070
First Posted
February 16, 2021
Last Updated
June 4, 2021
Sponsor
Mazandaran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04763070
Brief Title
Ciprofloxacin in Drug-resistant Epilepsy
Acronym
CIDRE
Official Title
Effect of Ciprofloxacin on Seizure Frequency in Patients With Drug-resistant Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mazandaran University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to investigate the effect of a short-term prescription of ciprofloxacin on intestinal microbial pattern and seizure frequency of patients with drug-resistant epilepsy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy Intractable
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ciprofloxacin
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin Oral Product
Intervention Description
The first stool sample will be taken before treatment and the second one will be taken in day 5 to 7 after treatment initiation. Treatment includes ciprofloxacin tablet 500mg twice a day for 5 days.
Primary Outcome Measure Information:
Title
Changes in seizure frequency registered in questionnaire
Description
Comparison of seizure frequency in 4th week with the frequency at the start of the study.
Time Frame
4 weeks
Title
Changes in quantity of microbial DNA extracted from stool samples by AccuPrep Stool DNA extraction Kit
Description
Comparison of quantity of extracted microbial DNA in stool sample taken at day5-7 with the sample taken at the start of the study
Time Frame
7 days
Title
Changes in microbial burden of stool samples using Absolute real time polymerase chain reaction (PCR)
Description
Comparison of microbial burden of stool samples taken at day5-7 with the sample taken at the start of the study
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Changes in seizure frequency registered in questionnaire
Description
Comparison of seizure frequency in 12th week with the frequency at the start of the study
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Drug-resistant epilepsy with frequency of at least 2 seizure/Week
Acceptance of patients or his/her guardian (Signing informed consent)
Exclusion Criteria:
Hypersensitivity to ciprofloxacin or other fluoroquinolones
History of tendon, renal, hepatic or cerebrovascular disease, organ transplantation or myasthenia gravis
Usage of medications with interaction to ciprofloxacin
No reliable contraception
Pregnancy or breastfeeding
Being under treatment with corticosteroid
Usage of antibiotics in recent 2 months or need to use it during the study
Patients who are candidate for epilepsy surgery or other nonmedical treatments
Change in anti-seizure medications (ASMs) during recent month
Patients who will need changes in ASMs dose during study
Facility Information:
Facility Name
Bu Ali Sina hospital
City
Sari
State/Province
Mazandaran
ZIP/Postal Code
4815838477
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ciprofloxacin in Drug-resistant Epilepsy
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