Ciprofloxacin in Drug-resistant Epilepsy

NCT04763070 | Completed DMC

• 1 other identifier: 5210
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy Intractable

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Changes in seizure frequency registered in questionnaire

  12 weeks

Study Arms (1)

Ciprofloxacin

OTHER

Drug: Ciprofloxacin Oral Product

Interventions

Ciprofloxacin Oral Product DRUG

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.

Ciprofloxacin

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Drug-resistant epilepsy with frequency of at least 2 seizure/Week
• Acceptance of patients or his/her guardian (Signing informed consent)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mazandaran University of Medical Sciences: lead

Study Sites (1)

Bu Ali Sina hospital

Sari, Mazandaran, 4815838477, Iran

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of neurology

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 21, 2021
• Study Start: October 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)