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Clinical Study Evaluating the Safety of Lactobacillus Probiotic in Children With Drug Resistant Epilepsy

Sponsor
Tanta University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05539287
Collaborator
(none)
60
Enrollment
2
Arms
15.2
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Animal and human studies have brought up evidence supporting Gut microbial disbalance, namely dysbiosis, as a causative factor of epilepsy, especially the refractory form. thus, probiotics might constitute a safe, low-cost, and effective supplementary therapy in patients with DRE.

The Lactobacillus population is probiotic bacteria that have a beneficial role in epilepsy. Lactobacillus can influence brain function through the modulation of GABA, as shown in rodent models. Moreover, it has been demonstrated in animal models of epilepsy and in human epileptic patients that probiotic treatment aimed at restoring gut microbiota equilibrium has beneficial effects on epileptic symptoms by increasing GABA in animals and the levels of Bifidobacteria and Lactobacillus in humans.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lactobacillus-Based Capsule
 Phase 2

Detailed Description

This study will be a placebo-controlled, double-blind, and parallel 6-month duration study

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Clinical Study Evaluating the Safety of Lactobacillus Probiotic in Children With Drug Resistant Epilepsy
Anticipated Study Start Date :
Sep 25, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Control group

30 patients will receive standard antiepileptic drug plus placebo capsules for 6 months.

Drug: Lactobacillus-Based Capsule
30 patients will receive Lactobacillus species 5 billion colonies forming unit (CFU) 2 capsules daily together with their standard antiepileptic drug for 6 months.
Other Names:
  • Lactobacillus

    		•
    Experimental: Probiotic Group

    30 patients will receive Lactobacillus species 5 billion colony forming unit (CFU) 2 capsules daily together with their standard antiepileptic drug for 6 months.

    Drug: Lactobacillus-Based Capsule
    30 patients will receive Lactobacillus species 5 billion colonies forming unit (CFU) 2 capsules daily together with their standard antiepileptic drug for 6 months.
    Other Names:
  • Lactobacillus

    		•

    Outcome Measures

    Primary Outcome Measures

    1. effectivness of Lactobacillus probiotics for controlling epileptic seizures in children with drug resistant epilepsy [6 months]

      effectivness can be defined as more than 50% reduction in number of seizures.

    Secondary Outcome Measures

    1. 1. the change in the measured biological parameters (NLRP3, and GAD-Ab) [6 months]

      Before and 6 months after intervention, 5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture between 8 am and 11 am. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of : Serum NLRP3 inflammasome level. Serum glutamic acid decarboxylase antibody (GAD-Ab).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients aged 3-18 years with intractable childhood-onset epilepsy.

    • All patients are diagnosed to have drug-resistant epilepsy (refractory epilepsy) according to the ILAE definition.

    • The subject is willing and able to comply with the study requirements

    Exclusion Criteria:

    • Any metabolic conditions that might increase the risks associated with trial participation or investigational product administration, such as hepatic enzyme elevation greater than twice normal and/or a GFR < 60 mL/min/1.73 m2 or electrolyte imbalance.

    • Patients who are currently using or used antibiotics therapy in the preceding month

    • Patients who are currently using or used other probiotic products in the preceding two weeks

    • Patients scheduled to undergo GIT surgery or those who underwent GIT surgery

    • Patients with a Known allergy to probiotics.

    • Patients receiving artificial enteral or intravenous nutrition

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Tanta University

    Investigators

    • Study Director: tarek mostafa, professor, Tanta University
    • Principal Investigator: Amira Rashdan, Rashdan, Tanta University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amira Roshdy, Assistant Lecturer of Clinical Pharmacy, Tanta University
    ClinicalTrials.gov Identifier:
    NCT05539287
    Other Study ID Numbers:
    • Lactobacillus in DRE.
    First Posted:
    Sep 14, 2022
    Last Update Posted:
    Sep 14, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Amira Roshdy, Assistant Lecturer of Clinical Pharmacy, Tanta University
    Lactobacillus
    Additional relevant MeSH terms:
    Epilepsy
    Drug Resistant Epilepsy

    Study Results

    No Results Posted as of Sep 14, 2022