CIDRE: Ciprofloxacin in Drug-resistant Epilepsy

Sponsor
Mazandaran University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT04763070
Collaborator
(none)
23
1
1
8
2.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ciprofloxacin Oral Product
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Ciprofloxacin on Seizure Frequency in Patients With Drug-resistant Epilepsy
Actual Study Start Date :
Oct 1, 2020
Actual Primary Completion Date :
Apr 1, 2021
Actual Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Ciprofloxacin

Drug: Ciprofloxacin Oral Product
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.

Outcome Measures

Primary Outcome Measures

  1. Changes in seizure frequency registered in questionnaire [4 weeks]

    Comparison of seizure frequency in 4th week with the frequency at the start of the study.

  2. Changes in quantity of microbial DNA extracted from stool samples by AccuPrep Stool DNA extraction Kit [7 days]

    Comparison of quantity of extracted microbial DNA in stool sample taken at day5-7 with the sample taken at the start of the study

  3. Changes in microbial burden of stool samples using Absolute real time polymerase chain reaction (PCR) [7 days]

    Comparison of microbial burden of stool samples taken at day5-7 with the sample taken at the start of the study

Secondary Outcome Measures

  1. Changes in seizure frequency registered in questionnaire [12 weeks]

    Comparison of seizure frequency in 12th week with the frequency at the start of the study

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bu Ali Sina hospital Sari Mazandaran Iran, Islamic Republic of 4815838477

Sponsors and Collaborators

  • Mazandaran University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nasim Tabrizi, Associate professor of neurology, Mazandaran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT04763070
Other Study ID Numbers:
  • 5210
First Posted:
Feb 21, 2021
Last Update Posted:
Jun 7, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 7, 2021