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The Effect of Probiotic Supplementation in Drug-resistant Epilepsy Patients

Primary Purpose

Epilepsy, Epilepsy Intractable

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Probiotic
Sponsored by
María Gómez Eguílaz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring epilepsy, microbiota, probiotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Probiotic

    Arm Description

    Probiotic administration

    Outcomes

    Primary Outcome Measures

    effectiveness of probiotics for controlling epileptic seizures in patients with drug-resistant epilepsy
    effectiveness can be defined as the reduction in number of seizures of at least 50%

    Secondary Outcome Measures

    Quality of life
    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
    To evaluate inflammatory markers: interleukin-6 (IL-6) and soluble CD14 (sCD14) in blood test.
    Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).
    Adverse events monitoring during the intervention.

    Full Information

    First Posted
    December 21, 2017
    Last Updated
    January 18, 2018
    Sponsor
    María Gómez Eguílaz
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03403907
    Brief Title
    The Effect of Probiotic Supplementation in Drug-resistant Epilepsy Patients
    Official Title
    The Effect of Probiotic Supplementation in Drug-resistant Epilepsy Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2014 (Actual)
    Primary Completion Date
    August 31, 2015 (Actual)
    Study Completion Date
    August 31, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    María Gómez Eguílaz

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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, 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy, Epilepsy Intractable
    Keywords
    epilepsy, microbiota, probiotics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Probiotic
    Arm Type
    Experimental
    Arm Description
    Probiotic administration
    Intervention Type
    Other
    Intervention Name(s)
    Probiotic
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    effectiveness of probiotics for controlling epileptic seizures in patients with drug-resistant epilepsy
    Description
    effectiveness can be defined as the reduction in number of seizures of at least 50%
    Time Frame
    From visit 2 to visit 3 (administration of probiotics, 4 months)
    Secondary Outcome Measure Information:
    Title
    Quality of life
    Description
    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
    Time Frame
    From visit 2 to visit 3 (administration of probiotics, 4 months)
    Title
    Assessing the anti-inflammatory effect of probiotics
    Description
    To evaluate inflammatory markers: interleukin-6 (IL-6) and soluble CD14 (sCD14) in blood test.
    Time Frame
    From visit 2 to visit 3 (administration of probiotics, 4 months)
    Title
    Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).
    Description
    Adverse events monitoring during the intervention.
    Time Frame
    From visit 2 to visit 3 (administration of probiotics, 4 months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    María Gómez Eguílaz
    Organizational Affiliation
    Fundación RiojaSalud
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21876150
    Citation
    Bravo JA, Forsythe P, Chew MV, Escaravage E, Savignac HM, Dinan TG, Bienenstock J, Cryan JF. Ingestion of Lactobacillus strain regulates emotional behavior and central GABA receptor expression in a mouse via the vagus nerve. Proc Natl Acad Sci U S A. 2011 Sep 20;108(38):16050-5. doi: 10.1073/pnas.1102999108. Epub 2011 Aug 29.
    Results Reference
    background
    PubMed Identifier
    25386066
    Citation
    Tojo R, Suarez A, Clemente MG, de los Reyes-Gavilan CG, Margolles A, Gueimonde M, Ruas-Madiedo P. Intestinal microbiota in health and disease: role of bifidobacteria in gut homeostasis. World J Gastroenterol. 2014 Nov 7;20(41):15163-76. doi: 10.3748/wjg.v20.i41.15163.
    Results Reference
    background
    PubMed Identifier
    30198325
    Citation
    Gomez-Eguilaz M, Ramon-Trapero JL, Perez-Martinez L, Blanco JR. The beneficial effect of probiotics as a supplementary treatment in drug-resistant epilepsy: a pilot study. Benef Microbes. 2018 Dec 7;9(6):875-881. doi: 10.3920/BM2018.0018. Epub 2018 Sep 10.
    Results Reference
    derived

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    The Effect of Probiotic Supplementation in Drug-resistant Epilepsy Patients

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