NCT05539287

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

September 25, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

July 1, 2025

Status Verified

August 1, 2023

Enrollment Period

1.9 years

First QC Date

September 10, 2022

Last Update Submit

June 29, 2025

Conditions

Drug Resistant Epilepsy

Keywords

Lactobacillus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    6 months

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Drug: Lactobacillus-Based Capsule

Probiotic Group

EXPERIMENTAL

25 patients will receive Lactobacillus species 5 billion colony forming unit (CFU) 2 capsules daily together with their standard antiepileptic drug for 6 months.

Drug: Lactobacillus-Based Capsule

Interventions

Lactobacillus-Based CapsuleDRUG

25 patients will receive Lactobacillus species 5 billion colonies forming unit (CFU) 2 capsules daily together with their standard antiepileptic drug for 6 months.

Also known as: Lactobacillus
Control groupProbiotic Group

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amira

Tanta, Egypt

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Lacteol

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • tarek mostafa, professor

    Tanta University

    STUDY DIRECTOR

  • Amira Rashdan, Rashdan

    Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Clinical Pharmacy

Study Record Dates

First Submitted

September 10, 2022

First Posted

September 14, 2022

Study Start

September 25, 2022

Primary Completion

August 5, 2024

Study Completion

February 1, 2025

Last Updated

July 1, 2025

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)