Probiotic Supplementation as an Adjuvant Therapy in Pediatric Drug-Resistant Epilepsy: A Double-Blind Placebo-Controlled Trial.

Probiotic supplementation significantly reduced seizure frequency in pediatric patients with drug-resistant epilepsy compared to the control group.

• The study was a randomized, double-blind, placebo-controlled trial with 60 pediatric DRE patients
• 30 patients received Lactobacillus acidophilus daily in addition to standard antiepileptic regimen; 30 received placebo plus standard regimen
• Standard antiepileptic regimen consisted of valproic acid, oxcarbazepine, and levetiracetam at maximum tolerated doses
• Seizure frequency reduction reached statistical significance at p = 0.04 after 6 months relative to the control group
• Study duration was 6 months with assessments at baseline and 6 months post-intervention

Probiotic supplementation significantly improved quality of life as measured by the QOLCE-55 questionnaire compared to the control group.

• Quality of life was assessed using the Quality of Life in Childhood Epilepsy (QOLCE-55) questionnaire as a primary endpoint
• The probiotic group showed a significant improvement in the QOLCE-55 total score (p < 0.0001) relative to the control group after 6 months
• This was one of two primary endpoints alongside seizure frequency

Probiotic supplementation significantly decreased serum levels of HMGB1, a neuroinflammatory marker, compared to the control group.

• HMGB1 (high-mobility group box 1 protein) was assessed as a secondary endpoint
• The probiotic group exhibited a significant decrease in serum HMGB1 levels (p = 0.0005) compared with the control group after 6 months
• HMGB1 is described as a mediator linked to neuroinflammatory mechanisms that compromise blood-brain barrier integrity and enhance seizure susceptibility

Probiotic supplementation significantly decreased serum levels of NLRP3 compared to the control group.

• NLRP3 (NLR family pyrin domain-containing 3) was measured as a secondary endpoint
• The probiotic group showed a significant decrease in serum NLRP3 levels (p = 0.002) relative to the control group after 6 months
• NLRP3 is an inflammasome component linked to neuroinflammatory immune pathways

Probiotic supplementation significantly decreased serum homocysteine levels compared to the control group.

• Homocysteine (Hcy) was assessed as a secondary endpoint
• The probiotic group exhibited a significant decrease in serum Hcy levels (p = 0.001) compared with the control group after 6 months

Probiotic supplementation significantly decreased serum IL-1β levels compared to the control group.

• IL-1β (interleukin-1β) was assessed as a secondary endpoint reflecting neuroinflammatory and immune pathway modulation
• The probiotic group showed a significant decrease in serum IL-1β levels (p = 0.05) compared with the control group after 6 months
• IL-1β is described as part of neuroinflammatory mechanisms driven by gut dysbiosis that modulate immune pathways

Drug-resistant epilepsy is linked to neuroinflammatory mechanisms driven by gut dysbiosis that compromise blood-brain barrier integrity and enhance seizure susceptibility.

• The background framework of the study connects gut dysbiosis to neuroinflammation as a mechanism underlying DRE
• These mechanisms are described as compromising blood-brain barrier integrity and modulating immune pathways
• This neuroinflammatory framework underscored the rationale for testing microbiota-targeted interventions (probiotics) in epilepsy