The Effect of Probiotic Supplementation in Drug-resistant Epilepsy Patients

Epilepsy Clinical Trial

Official title:

The Effect of Probiotic Supplementation in Drug-resistant Epilepsy Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03403907
• Other study ID #: probiotico-epilepsia-001
• Status: Completed
• Phase: N/A
• First received: December 21, 2017
• Last updated: January 18, 2018
• Start date: October 1, 2014
• Est. completion date: August 31, 2015

Study information

• Verified date: January 2018
• Source: Fundación RiojaSalud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 31, 2015
• Est. primary completion date: August 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Epilepsy Intractable

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
María Gómez Eguílaz

References & Publications (2)

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. — View Citation

Tojo R, Suárez A, Clemente MG, de los Reyes-Gavilán 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%	From visit 2 to visit 3 (administration of probiotics, 4 months)
Secondary	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	From visit 2 to visit 3 (administration of probiotics, 4 months)
Secondary	Assessing the anti-inflammatory effect of probiotics	To evaluate inflammatory markers: interleukin-6 (IL-6) and soluble CD14 (sCD14) in blood test.	From visit 2 to visit 3 (administration of probiotics, 4 months)
Secondary	Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).	Adverse events monitoring during the intervention.	From visit 2 to visit 3 (administration of probiotics, 4 months)