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The Effect of Probiotic Supplementation in Drug-resistant Epilepsy Patients

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What is being tested

Probiotic

Other
Who is being recruted

Drug Resistant Epilepsy+2

+ Brain Diseases

+ Central Nervous System Diseases

Over 18 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: October 2014
See protocol details

Summary

Principal SponsorMaría Gómez Eguílaz
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2014

Actual date on which the first participant was enrolled.

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.

Official TitleThe Effect of Probiotic Supplementation in Drug-resistant Epilepsy Patients
NCT03403907
Principal SponsorMaría Gómez Eguílaz
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Drug Resistant EpilepsyBrain DiseasesCentral Nervous System DiseasesEpilepsyNervous System Diseases

Criteria

5 inclusion criteria required to participate
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.

Show More Criteria

16 exclusion criteria prevent from participating
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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Probiotic administration

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers
The Effect of Probiotic Supplementation in Drug-resistant Epilepsy Patients | PatLynk