NCT03403907

The Effect of Probiotic Supplementation in Drug-resistant Epilepsy Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: María Gómez Eguílaz · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, 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.

Conditions

• Epilepsy
• Epilepsy Intractable

Interventions

Type	Name	Description
OTHER	Probiotic	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).

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-08-31
• Completion: 2015-08-31
• First posted: 2018-01-19
• Last updated: 2018-01-19