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

NCT ID: NCT05539287

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-25
• Study Completion Date: 2025-02-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

25 patients will receive standard antiepileptic drug plus placebo capsules for 6 months.

Group Type: PLACEBO_COMPARATOR

Lactobacillus-Based Capsule

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Lactobacillus-Based Capsule

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Lactobacillus

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Amira Roshdy

Assistant Lecturer of Clinical Pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

tarek mostafa, professor

Role: STUDY_DIRECTOR

Tanta University

Amira Rashdan, Rashdan

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

Amira

Tanta, , Egypt

Countries

Egypt

Other Identifiers

Lactobacillus in DRE.

Identifier Type: -

Identifier Source: org_study_id