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

Tanta University

Status and phase: Completed; Phase 2

Conditions: Drug Resistant Epilepsy

Treatments: Drug: Lactobacillus-Based Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT05539287

Lactobacillus in DRE.

Details and patient eligibility

About

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.

Full description

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

Enrollment: 60 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Lactobacillus-Based Capsule

Probiotic Group

Experimental group

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.

Treatment:

Drug: Lactobacillus-Based Capsule