EpilepsyNCT03403907
The Effect of Probiotic Supplementation in Drug-resistant Epilepsy Patients
A study testing Probiotic in people with Epilepsy and Epilepsy Intractable, run by María Gómez Eguílaz.
Trial summary
This study evaluates the effect of probiotic supplementation in patients with drug-resistant epilepsy. All the patients received the probiotic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Epilepsy Intractable
- What is being tested?
- Probiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2014to 31 Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
This study evaluates the effect of probiotic supplementation in patients with drug-resistant epilepsy. All the patients received the probiotic.
Read the 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.
- Conditions
- Epilepsy, Epilepsy Intractable
- Being tested
- Probiotic
- Keywords
- epilepsy, microbiota, probiotics
- Medical subject headings
- Epilepsy, Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticOther
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 group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Probiotic administration Receives: Other: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: From visit 2 to visit 3 (administration of probiotics, 4 months)
Secondary outcomes (3)
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
Measured: From visit 2 to visit 3 (administration of probiotics, 4 months)
Assessing the anti-inflammatory effect of probiotics
To evaluate inflammatory markers: interleukin-6 (IL-6) and soluble CD14 (sCD14) in blood test.
Measured: From visit 2 to visit 3 (administration of probiotics, 4 months)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).
Adverse events monitoring during the intervention.
Measured: From visit 2 to visit 3 (administration of probiotics, 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start1 Oct 2014
- Primary completion31 Aug 2015
- Study completion31 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- María Gómez Eguílaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, María Gómez Eguílaz, Fundacion Rioja Salud
- Investigators
- María Gómez Eguílaz, Principal investigator, Fundacion Rioja Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403907
- Sponsor's protocol ID
- probiotico-epilepsia-001
- Status last verified
- Jan 2018
- First submitted
- 21 Dec 2017
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21876150Tojo 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.
PubMed 25386066Gomez-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.
PubMed 30198325
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotic Supplementation in Drug-resistant Epilepsy Patients
- ClinicalTrials.gov ID
- NCT03403907
- Acronym / sponsor ID
- probiotico-epilepsia-001
- Conditions
- Epilepsy, Epilepsy Intractable
- Keywords
- epilepsy, microbiota, probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- María Gómez EguílazUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 31 Aug 2015 (actual)
- Study completion
- 31 Aug 2015 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Other: ProbioticProbiotic administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotictwice 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). | Other | Probiotic |
Primary outcome
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%
3 secondary outcomes
Quality of life
Time frame: From visit 2 to visit 3 (administration of probiotics, 4 months)
Assessing the anti-inflammatory effect of probiotics
Time frame: From visit 2 to visit 3 (administration of probiotics, 4 months)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).
Time frame: From visit 2 to visit 3 (administration of probiotics, 4 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Background: PubMed 21876150Bravo 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.
- Background: PubMed 25386066Tojo 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.
- Derived from this study: PubMed 30198325Gomez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María Gómez Eguílaz principal investigator
Fundacion Rioja Salud
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Epilepsy and Epilepsy Intractable, run by María Gómez Eguílaz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03403907, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2018.