Ciprofloxacin in Drug-resistant Epilepsy

Mazandaran University of Medical Sciences23 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Epilepsy Intractable

Interventions

Ciprofloxacin Oral ProductDRUG

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.

Eligibility

Sex: ALLMin age: 16 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Bu Ali Sina hospital

Sari, Mazandaran, Iran

Outcomes

Primary Outcomes

Changes in seizure frequency registered in questionnaire

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

Time frame: 4 weeks

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

Time frame: 7 days

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

Time frame: 7 days

Secondary Outcomes

Changes in seizure frequency registered in questionnaire

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

Time frame: 12 weeks

Data from ClinicalTrials.gov

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