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NCT Number: NCT05539287

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.

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Key information

Conditions

Drug Resistant Epilepsy Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Amira

Tanta, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus-Based Capsule

Drug

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

Primary outcomes

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

    Time frame: 6 months

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

Secondary outcomes

  1. 1. the change in the concentration of measured biological parameters (NLRP3, and GAD-Ab)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Sep 14, 2022
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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