Ciprofloxacin in Drug-resistant Epilepsy

Epilepsy Intractable Clinical Trial

— CIDRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04763070
• Other study ID #: 5210
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2021
• Source: Mazandaran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Epilepsy Intractable

Intervention

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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Bu Ali Sina hospital	Sari	Mazandaran

Sponsors (1)

Lead Sponsor	Collaborator
Mazandaran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in seizure frequency registered in questionnaire	Comparison of seizure frequency in 4th week with the frequency at the start of the study.	4 weeks
Primary	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	7 days
Primary	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	7 days
Secondary	Changes in seizure frequency registered in questionnaire	Comparison of seizure frequency in 12th week with the frequency at the start of the study	12 weeks