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

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.

Study Overview

• Status: Completed
• Conditions: Drug Resistant Epilepsy
• Intervention / Treatment: Drug: Lactobacillus-Based Capsule

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Amira

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; 25 patients will receive standard antiepileptic drug plus placebo capsules for 6 months.	Drug: Lactobacillus-Based Capsule; 25 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; 25 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; 25 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effectivness of Lactobacillus probiotics for controlling epileptic seizures in children with drug resistant epilepsy	effectivness can be defined as more than 50% reduction in number of seizures.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. the change in the concentration of measured biological parameters (NLRP3, and GAD-Ab)	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).	6 months

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Amira Rashdan, Rashdan, Tanta university; Study Director: tarek mostafa, professor, Tanta university

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2022
• Primary Completion (Actual): August 5, 2024
• Study Completion (Actual): February 1, 2025

Study Registration Dates

• First Submitted: September 10, 2022
• First Submitted That Met QC Criteria: September 10, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 29, 2025
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Lactobacillus
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Drug Resistant Epilepsy; Epilepsy
• Other Study ID Numbers: Lactobacillus in DRE.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No