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Evaluation of co-amoxiclav on seizure frequency in drug-resistant epilepsy in children

Evaluation of co-amoxiclav on seizure frequency in drug-resistant epilepsy in children

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090412001808N8
Enrollment
25
Registered
2024-01-29
Start date
2021-06-22
Completion date
Unknown
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy. Epilepsy and recurrent seizures

Interventions

Administer coamoxiclav at a dose of 40 mg/kg/d in two divided doses for 5 days.

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 18 Years

Inclusion criteria

Inclusion criteria: Children aged 3-18 years An established diagnosis of drug-resistant epilepsy with two or more seizures during the 7-day baseline period Consent of the patient or the patient's guardian to participate in the study

Exclusion criteria

Exclusion criteria: History of penicillin allergy Patients treated with co-amoxiclav interfering drugs reception of corticosteroids Taking antibiotics in the last 1 month or needing to take another antibiotic during the study period Liver disease Patients who were candidates for epilepsy surgery or other non-pharmacological methods Patients who need to change the dose of anticonvulsant during the study period

Design outcomes

Primary

MeasureTime frame
The primary laboratory outcome is defined as changes in the microbial load of different species in stool samples on the fifth day compared to baseline. Timepoint: The first stool sample is taken from patients after the initial interview. The second stool sample is taken after 5 days of taking co-amoxiclav, 5-7 days apart from the first sample. Method of measurement: Bacterial copy number is determined in patients' feces samples using real-time PCR technique.;The primary clinical outcome is response rate at week 12. A response rate of =50% reduction in seizures is classified as "responder" and less than 50% reduction in seizure frequency is classified as "non-responder". Timepoint: The patient and his/her family are asked to record the frequency of seizures up to 12 weeks after receiving the drug. Method of measurement: Self report.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Abaskhanian

Mazandaran University of Medical Sciences

aabbaskhanian@mazums.ac.ir+98 11 3334 3010

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026