drugset / Trial / NCT05539287

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

NCT05539287

Phase 2 Completed 60 enrolled Tanta University
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2022-09-25
Primary completion
2024-08-05
Completion
2025-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Lactobacillus acidophilus Other / unclassified 5e+09 unknown

Indications