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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
Sponsor:
Information provided by (Responsible Party):
María Gómez Eguílaz, Fundación RiojaSalud

Brief Summary:
This study evaluates the effect of probiotic supplementation in patients with drug-resistant epilepsy. All the patients received the probiotic.

Condition or disease Intervention/treatment Phase
Epilepsy Epilepsy Intractable Other: Probiotic Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

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).




Primary Outcome Measures :
  1. 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%


Secondary Outcome Measures :
  1. 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


  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
María Gómez Eguílaz
Investigators
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Principal Investigator: María Gómez Eguílaz Fundación RiojaSalud

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: María Gómez Eguílaz, principal investigator, Fundación RiojaSalud
ClinicalTrials.gov Identifier: NCT03403907     History of Changes
Other Study ID Numbers: probiotico-epilepsia-001
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by María Gómez Eguílaz, Fundación RiojaSalud:
epilepsy
microbiota
probiotics

Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases