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
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring epilepsy, microbiota, probiotics
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.
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
NCT ID
NCT03403907
First Posted
December 21, 2017
Last Updated
January 18, 2018
Sponsor
María Gómez Eguílaz
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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