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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.
This study will be a placebo-controlled, double-blind, and parallel 6-month duration study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | 25 patients will receive standard antiepileptic drug plus placebo capsules for 6 months. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus-Based Capsule | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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biological parameters (NLRP3, and GAD-Ab) | Before and 6 months after intervention, 5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture between 8 am and 11 am.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 :
|
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Inclusion Criteria:
Patients aged 3-18 years with intractable childhood-onset epilepsy.
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.
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| Name | Affiliation | Role |
|---|---|---|
| tarek mostafa, professor | Tanta University | Study Director |
| Amira Rashdan, Rashdan | Tanta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amira | Tanta | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41693686 | Derived | Rashdan AR, El-Haggar SM, Kishk AM, Mostafa TM. Probiotic Supplementation as an Adjuvant Therapy in Pediatric Drug-Resistant Epilepsy: A Double-Blind Placebo-Controlled Trial. Pharmacotherapy. 2026 Mar;46(3):e70117. doi: 10.1002/phar.70117. |
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| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C100843 | Lacteol |
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|
| 6 months |