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

Primary Purpose

Drug Resistant Epilepsy

Status

Recruiting

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Lactobacillus-Based Capsule

About this trial

This is an interventional treatment trial for Drug Resistant Epilepsy focused on measuring Lactobacillus

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

AmiraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

Probiotic Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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Before and 6 months after intervention, 5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture between 8 am and 11 am.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).

Full Information

NCT ID

NCT05539287

First Posted

September 10, 2022

Last Updated

October 6, 2022

Sponsor

Tanta University

1. Study Identification

Unique Protocol Identification Number

NCT05539287

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 25, 2022 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Drug Resistant Epilepsy

Keywords

Lactobacillus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Probiotic Group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Lactobacillus-Based Capsule

Other Intervention Name(s)

Lactobacillus

Intervention Description

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

Primary Outcome Measure Information:

Title

effectivness of Lactobacillus probiotics for controlling epileptic seizures in children with drug resistant epilepsy

Description

effectivness can be defined as more than 50% reduction in number of seizures.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amira Rashdan, Rashdan

Phone

01022677143

amira.rashdan@pharm.tanta.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmed kishk, Lecturer

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

tarek mostafa, professor

Organizational Affiliation

Tanta University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Amira Rashdan, Rashdan

Organizational Affiliation

Tanta University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Amira

City

Tanta

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

amira roshdy, assisstant lecturer

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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