Ciprofloxacin in Drug-resistant Epilepsy

Not Applicable

Completed

• Conditions: Epilepsy Intractable
• Interventions: Drug: Ciprofloxacin Oral Product

• Registration Number: NCT04763070
• Lead Sponsor: Mazandaran University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-21
• Primary Completion: 2021-04-01
• Status Verified: 2021-06
• Study Completion: 2021-06-01
• Last Update Submitted: 2021-06-04
• Last Update Posted: 2021-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ciprofloxacin	Ciprofloxacin Oral Product	-

Primary Outcome Measures

Name	Time	Method
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.
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
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

Name	Time	Method
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

Trial Locations

Locations (1)

Bu Ali Sina hospital; 🇮🇷 Sari, Mazandaran, Iran, Islamic Republic of