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The Effect of Probiotic Supplementation in Drug-resistant Epilepsy Patients

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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

Tracking Information
First Submitted Date  ICMJE December 21, 2017
First Posted Date  ICMJE January 19, 2018
Last Update Posted Date January 19, 2018
Actual Study Start Date  ICMJE October 1, 2014
Actual Primary Completion Date August 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2018)
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%
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2018)
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Probiotic Supplementation in Drug-resistant Epilepsy Patients
Official Title  ICMJE The Effect of Probiotic Supplementation in Drug-resistant Epilepsy Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Epilepsy
  • Epilepsy Intractable
Intervention  ICMJE 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).
Study Arms  ICMJE Experimental: Probiotic
Probiotic administration
Intervention: Other: Probiotic
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2018)
45
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 31, 2015
Actual Primary Completion Date August 31, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03403907
Other Study ID Numbers  ICMJE probiotico-epilepsia-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party María Gómez Eguílaz, Fundación RiojaSalud
Study Sponsor  ICMJE María Gómez Eguílaz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: María Gómez Eguílaz Fundación RiojaSalud
PRS Account Fundación RiojaSalud
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP