Status:
COMPLETED
The Effect of Probiotic Supplementation in Drug-resistant Epilepsy Patients
Lead Sponsor:
María Gómez Eguílaz
Conditions:
Epilepsy
Epilepsy Intractable
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study evaluates the effect of probiotic supplementation in patients with drug-resistant epilepsy. All the patients received the probiotic.
Detailed Description
Epilepsy is a neurological disease with a prevalence of 0.6%. Despite the high number of antiepileptic drugs available, 20-30% of patients fail to control their seizures even with a correct treatment,...
Eligibility Criteria
Inclusion
- Older than 18 years-old.
- Diagnosis of drug-resistant epileptic seizures.
- Under stable treatment with antiepileptic drugs for at least 30 days before their inclusion.
- Occurrence of at least one seizure per month.
- Acceptance and informed consent for the inclusion of the patient in the study protocol.
Exclusion
- Stable epilepsy.
- Idiopathic generalized epilepsy.
- Epileptic status in the previous 12 months.
- Change in the dose or type of antiepileptic drug within 30 days prior to the start of the study.
- Active consumption of alcohol or substances of abuse.
- Pregnancy and / or mothers during lactation period.
- Patients treated with probiotics from 30 days before the start of the study.
- Chronic gastrointestinal problems (for example irritable bowel).
- Liver or kidney problems.
- Lactose intolerant or celiac.
- Immunosuppressed.
- Patients on chronic antibiotic treatment.
- Impossibility to fill in a questionnaire, by the patient or the person responsible, and to follow the schedule of visits.
- Progressive neurological deterioration (tumors or metastasis of the central nervous system (CNS), Alzheimer's disease, vascular dementias).
- Use of antiepileptic drugs in research.
- Patients with an expectation of life \<1 year.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2015
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03403907
Start Date
October 1 2014
End Date
August 31 2015
Last Update
January 19 2018
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