The Effect of Probiotic Supplementation in Drug-resistant Epilepsy Patients

NCT03403907 | Completed

• 1 other identifier: probiotico-epilepsia-001
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Epilepsy; Epilepsy Intractable

Keywords

epilepsy; microbiota; probiotics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Quality of life

  From visit 2 to visit 3 (administration of probiotics, 4 months)

• Assessing the anti-inflammatory effect of probiotics

  From visit 2 to visit 3 (administration of probiotics, 4 months)

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).

  From visit 2 to visit 3 (administration of probiotics, 4 months)

Study Arms (1)

Probiotic

EXPERIMENTAL

Probiotic administration

Other: Probiotic

Interventions

Probiotic OTHER

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).

Probiotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years-old.
• Diagnosis of drug-resistant epileptic seizures.
• Occurrence of at least one seizure per month.

You may not qualify if:

• 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.

Sponsors & Collaborators

• María Gómez Eguílaz: lead

Related Publications (3)

• 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.

  PMID: 21876150 BACKGROUND

• 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.

  PMID: 25386066 BACKGROUND

• 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.

  PMID: 30198325 DERIVED

MeSH Terms

Conditions

Epilepsy; Drug Resistant Epilepsy

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• María Gómez Eguílaz

  Fundación RiojaSalud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: January 19, 2018
• Study Start: October 1, 2014
• Primary Completion: August 31, 2015
• Study Completion: August 31, 2015
• Last Updated: January 19, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share