NCT05539287

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Drug Resistant Epilepsy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-25
• Primary completion: 2024-08-05
• Completion: 2025-02-01
• First posted: 2022-09-14
• Last updated: 2025-07-01

Locations

1 site across 1 country: Egypt