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CompletedNCT04763070CIDREUpdated Jun 7, 2021

Ciprofloxacin in Drug-resistant Epilepsy

An interventional study of Ciprofloxacin Oral Product in Epilepsy Intractable, sponsored by Mazandaran University of Medical Sciences. Completed at 1 site in Iran. Open to participants aged 16 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-06-07.

Sponsored by Mazandaran University of Medical Sciences · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Oct 2020, registered Feb 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
16 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Epilepsy Intractable
03

In context

Drug Resistant Epilepsy

270 studies on the registry are indexed under Drug Resistant Epilepsy; 100 are open to participants now.

This study's enrollment of 23 is below the median of 30 across 213 interventional studies indexed under Drug Resistant Epilepsy.

Browse Drug Resistant Epilepsy studies →

Lead sponsor

Mazandaran University of Medical Sciences is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Other
    Ciprofloxacin

    Drug: Ciprofloxacin Oral Product

Interventions

  • 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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. 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

07

Study locations

1 site
  • Bu Ali Sina hospital
    Sari, Mazandaran 4815838477, Iran
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04763070
Lead sponsor
Mazandaran University of Medical Sciences
Responsible party
Nasim Tabrizi (Associate professor of neurology, Mazandaran University of Medical Sciences) — Principal investigator
First posted
Feb 21, 2021
Start date
Oct 1, 2020
Primary completion
Apr 1, 2021
Completion
Jun 1, 2021
Last update
Jun 7, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ciprofloxacin

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