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Published on: September 20, 2024
Probiotic Supplementation as an Adjuvant Therapy in Pediatric Drug-Resistant Epilepsy: A Double-Blind
Amira R Rashdan1, Sahar M El-Haggar1, Ahmed Mustafa Kishk2
1Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, Tanta, Egypt.
Insights
Lactobacillus acidophilus supplementation significantly reduced seizure frequency and improved quality of life in children with drug-resistant epilepsy. This probiotic intervention also decreased key inflammatory markers, suggesting a role in managing epilepsy through gut-brain axis modulation.
Area of Science:
- Neuroscience
- Microbiology
- Clinical Medicine
Background:
- Drug-resistant epilepsy (DRE) is increasingly linked to neuroinflammation and gut dysbiosis.
- These factors compromise blood-brain barrier integrity and increase seizure susceptibility.
- Microbiota-targeted interventions show therapeutic potential for epilepsy.
Purpose of the Study:
- To assess the effectiveness of probiotics as adjunctive therapy for children with DRE.
- To evaluate the impact of probiotics on drug sensitivity and clinical outcomes.
- To investigate the effect of probiotics on inflammatory markers.
Main Methods:
- A 6-month randomized, double-blind, placebo-controlled trial involving 60 pediatric patients with DRE.
- Participants received standard antiepileptic drugs plus either Lactobacillus acidophilus or a placebo.
- Primary outcomes included seizure frequency and quality of life (QOLCE-55); secondary outcomes included serum inflammatory markers (HMGB1, IL-1β, Hcy, NLRP3).
Main Results:
- The probiotic group showed a significant reduction in seizure frequency (p=0.04) and improved QOLCE-55 scores (p<0.0001) compared to placebo.
- Significant decreases in serum HMGB1, NLRP3, Hcy, and IL-1β levels were observed in the probiotic group.
- These findings suggest a positive impact of Lactobacillus acidophilus on both clinical and biochemical markers in DRE.
Conclusions:
- Lactobacillus acidophilus supplementation may enhance conventional antiepileptic drug efficacy in children with DRE.
- Probiotic use appears to reduce systemic inflammation and improve quality of life.
- Further research is needed to validate these promising findings for DRE management.
Background:
Drug-resistant epilepsy (DRE) is increasingly linked to neuroinflammatory mechanisms driven by gut dysbiosis. These mechanisms compromise blood-brain barrier integrity, enhance seizure susceptibility, and modulate immune pathways. These insights underscore the therapeutic potential of microbiota-targeted interventions in epilepsy.
Aim:
The study aimed at assessing the effectiveness of probiotics as an adjunctive therapy to enhance drug sensitivity and clinical outcomes in children with DRE.
Methods:
This randomized, double-blind, placebo-controlled trial enrolled 60 pediatric patients with DRE who were assigned to either the control group (n = 30), which received a standard antiepileptic regimen (valproic acid, oxcarbazepine, and levetiracetam at the maximum tolerated doses) plus a daily placebo capsule, or the probiotic group (n = 30), which received the same antiepileptic regimen plus a daily probiotic (Lactobacillus acidophilus) supplement. The study duration was 6 months. Assessments of clinical and biochemical outcomes were conducted at baseline and 6 months after intervention. Primary end points included seizure frequency and change in quality of life as measured by the quality of life in childhood epilepsy (QOLCE-55) questionnaire. Secondary end points included the change in the serum levels of high-mobility group box 1 protein (HMGB1), interleukin-1β (IL-1β), homocysteine (Hcy), and NLR family pyrin domain-containing 3 (NLRP3).
Results:
After 6 months and relative to the control group, the probiotic (Lactobacillus acidophilus) group experienced a significant decline in seizure frequency (p = 0.04) and a significant improvement in the QOLCE-55 total score (p < 0.0001). Additionally, the probiotic group exhibited significant decreases in the serum levels of HMGB1 (p = 0.0005), NLRP3 (p = 0.002), Hcy (p = 0.001), and IL-1β (p = 0.05) compared with the control group.
Conclusion:
Lactobacillus acidophilus supplementation appears to enhance the effectiveness of conventional antiepileptic drugs, reduce systemic inflammation, improve quality of life, and reduce seizure frequency in children with DRE. However, further validation is necessary.
Gov Registration Number:
NCT05539287.
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