The Effect of Probiotic Supplementation in Drug-resistant Epilepsy Patients

January 18, 2018 updated by: María Gómez Eguílaz
This study evaluates the effect of probiotic supplementation in patients with drug-resistant epilepsy. All the patients received the probiotic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic
Probiotic administration
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%
From visit 2 to visit 3 (administration of probiotics, 4 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From visit 2 to visit 3 (administration of probiotics, 4 months)
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.
From visit 2 to visit 3 (administration of probiotics, 4 months)
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.
From visit 2 to visit 3 (administration of probiotics, 4 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

María Gómez Eguílaz

Investigators

  • Principal Investigator: María Gómez Eguílaz, Fundación RiojaSalud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

August 31, 2015

Study Completion (Actual)

August 31, 2015

Study Registration Dates

First Submitted

December 21, 2017

First Submitted That Met QC Criteria

January 18, 2018

First Posted (Actual)

January 19, 2018

Study Record Updates

Last Update Posted (Actual)

January 19, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • probiotico-epilepsia-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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