The Effect of Probiotic Supplementation in Drug-resistant Epilepsy Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03403907|
Recruitment Status : Completed
First Posted : January 19, 2018
Last Update Posted : January 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy Epilepsy Intractable||Other: Probiotic||Not Applicable|
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, this is known as drug-resistant epilepsy. This type of epilepsy limits severely the quality of life in patients and increases their morbidity and mortality.
There are different therapeutic strategies for the treatment of drug-resistant epilepsy such as the vagus nerve stimulation, which has an effectiveness of approximately 50% reduction of seizures in 50% of patients. Another one is epilepsy surgery, which can achieve up to 70% of crisis control with specifically selected surgery for certain patients. On the other hand, the ketogenic diet has nearly 30% effectiveness, which is defined as a seizure reduction of more than 50%. Despite all these treatments, there is still a group of patients that keeps showing epileptic seizures.
The microbiota is a collective of microorganisms that live in a symbiotic relationship within our organism. Currently, it is known that there is a bidirectional relationship between microbiota-gut-brain. Probiotics are live microorganisms that can benefit the health of the host when administered in adequate doses.
The purpose of the study is to prove the quality of life improvement in drug-resistant patients after the administration of a probiotic for 4 months in order to reduce the number of seizures. Additionally, the parameters of inflammatory cytokines will be evaluated as well as the probiotic medication safety will be assessed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Probiotic Supplementation in Drug-resistant Epilepsy Patients|
|Actual Study Start Date :||October 1, 2014|
|Actual Primary Completion Date :||August 31, 2015|
|Actual Study Completion Date :||August 31, 2015|
twice a day for 4 months (Streptococcus thermophilus, Lactobacillus acidophilus, L.plantarum, L. paracasei, L. delbrueckii subs bulgaricus, Bifidobacterium breve, B.longus y B.infantis. y CD2).
- effectiveness of probiotics for controlling epileptic seizures in patients with drug-resistant epilepsy [ Time Frame: From visit 2 to visit 3 (administration of probiotics, 4 months) ]effectiveness can be defined as the reduction in number of seizures of at least 50%
- Quality of life [ Time Frame: From visit 2 to visit 3 (administration of probiotics, 4 months) ]
Measured by the questionnaire of quality of life in epilepsy (QOLIE-10) in Spanish language 10-item questionnaire for screening quality-of-life issues for patients with epilepsy, in clinical practice. It evaluates: epilepsy effects, mental health and role function.
The minimum of scale is 10-maximun: 50 10-19: very well; could hardly be better 20-29: pretty good 30-39: godd and bad parts about equal 40-49: pretty bad 50: very bad; could hardly be worse
- Assessing the anti-inflammatory effect of probiotics [ Time Frame: From visit 2 to visit 3 (administration of probiotics, 4 months) ]To evaluate inflammatory markers: interleukin-6 (IL-6) and soluble CD14 (sCD14) in blood test.
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability). [ Time Frame: From visit 2 to visit 3 (administration of probiotics, 4 months) ]Adverse events monitoring during the intervention.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403907
|Principal Investigator:||María Gómez Eguílaz||Fundación RiojaSalud|