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Completed

NCT Number: NCT04763070

Ciprofloxacin in 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.

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Key information

Conditions

Epilepsy Intractable Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Epilepsy Nervous System Diseases

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bu Ali Sina hospital

Sari, Mazandaran, 4815838477, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Mazandaran University of Medical Sciences

Other

Registry information

Official study title

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

Acronym: CIDRE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 21, 2021
Registry last updated
Jun 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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