CIDRE: Ciprofloxacin in Drug-resistant Epilepsy
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: Ciprofloxacin
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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.
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Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Drug-resistant epilepsy with frequency of at least 2 seizure/Week
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Acceptance of patients or his/her guardian (Signing informed consent)
Exclusion Criteria:
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Hypersensitivity to ciprofloxacin or other fluoroquinolones
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History of tendon, renal, hepatic or cerebrovascular disease, organ transplantation or myasthenia gravis
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Usage of medications with interaction to ciprofloxacin
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No reliable contraception
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Pregnancy or breastfeeding
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Being under treatment with corticosteroid
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Usage of antibiotics in recent 2 months or need to use it during the study
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Patients who are candidate for epilepsy surgery or other nonmedical treatments
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Change in anti-seizure medications (ASMs) during recent month
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Patients who will need changes in ASMs dose during study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Bu Ali Sina hospital | Sari | Mazandaran | Iran, Islamic Republic of | 4815838477 |
Sponsors and Collaborators
- Mazandaran University of Medical Sciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 5210