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

Drug Resistant Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05539287
• Other study ID #: Lactobacillus in DRE.
• Status: Recruiting
• Phase: Phase 2
• Start date: September 25, 2022
• Est. completion date: January 2025

Study information

• Verified date: October 2022
• Source: Tanta University
• Contact: Amira Rashdan, Rashdan
• Phone: 01022677143
• Email: amira.rashdan[@]pharm.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy

Intervention

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.

Locations

Country	Name	City	State
Egypt	Amira	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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