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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Epilepsy Epilepsy Intractable | Other: Probiotic | Not Applicable |
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 (Clinical Trial) |
Actual Enrollment : | 45 participants |
Allocation: | N/A |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Probiotic
Probiotic administration
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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). |
- 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%
- 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.

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

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
Principal Investigator: | María Gómez Eguílaz | Fundación RiojaSalud |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | María Gómez Eguílaz, principal investigator, Fundación RiojaSalud |
ClinicalTrials.gov Identifier: | NCT03403907 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
epilepsy microbiota probiotics |
Epilepsy Drug Resistant Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |