Ciprofloxacin in Drug-resistant Epilepsy (CIDRE)

June 4, 2021 updated by: Nasim Tabrizi, Mazandaran University of Medical Sciences

Effect of Ciprofloxacin on Seizure Frequency in Patients With Drug-resistant Epilepsy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 46 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in seizure frequency registered in questionnaire
Time Frame: 4 weeks
Comparison of seizure frequency in 4th week with the frequency at the start of the study.
4 weeks
Changes in quantity of microbial DNA extracted from stool samples by AccuPrep Stool DNA extraction Kit
Time Frame: 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
7 days
Changes in microbial burden of stool samples using Absolute real time polymerase chain reaction (PCR)
Time Frame: 7 days
Comparison of microbial burden of stool samples taken at day5-7 with the sample taken at the start of the study
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in seizure frequency registered in questionnaire
Time Frame: 12 weeks
Comparison of seizure frequency in 12th week with the frequency at the start of the study
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mazandaran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

February 16, 2021

First Submitted That Met QC Criteria

February 17, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

June 7, 2021

Last Update Submitted That Met QC Criteria

June 4, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5210

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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