The effect of synbiotics in the treatment of drug-resistant epilepsy and the parental burden of caregivers: a single-arm pretest-posttest trial

Background: In patients with drug-resistant epilepsy (DRE), the composition of the gut microbiome changes compared to drug-sensitive patients and healthy individuals. Synbiotics, a mixture of probiotics and prebiotics, aim to improve the balance of bacteria in the gut microbiome. This study aimed to assess the effect of synbiotics on the treatment of DRE and the burden on caregivers. Methods: This one-group pretest-posttest quasi-experimental study was conducted in Arak, Iran. Thirty children with DRE, diagnosed by a pediatric neurologist and meeting the inclusion criteria in ۲۰۲۱-۲۲, were included in the study. In addition to anticonvulsant drugs, infants were administered PediLact at a dose of ۵-۱۵ drops per day for eight weeks, and KidiLact at a dose of one sachet per day for eight weeks for children aged ۲-۱۵ years. Both PediLact and KidiLact are synbiotics. To investigate the burden on caregivers (parents), the Zarit Caregiver Burden Interview was conducted. In addition, the number of epileptic seizures was assessed from mothers before and immediately after the intervention over one month. Results: The mean age of the participants in the study was ۸.۶ years (SD: ۳.۴). Eighteen participants (۶۰%) were boys, and ۱۲ (۴۰%) were girls. The results of the study showed a statistically significant decrease in the mean burden on caregivers, from ۳۴.۲۰ (SD: ۱۴.۴) before the intervention to ۳۰.۲۶ (SD: ۱۵.۸) after the intervention (P = ۰.۰۱۷). The mean frequency of seizures decreased significantly, from ۱۵.۸۳ (SD: ۱۲.۹) before the intervention to ۱۲.۷۳ (SD: ۱۲.۸) after the intervention (P=۰.۰۰۱). Following the intervention, the seizure frequency stopped in two patients, decreased by ۵۰% in six patients, increased in one patient, and remained unchanged in ۲۱ patients. Conclusion: The results suggest that Symbiotics in DRE patients are associated with a lower parental burden of caregivers and seizure frequency. Well-designed randomized clinical trial studies are recommended to generate rigorous causal evidence and conclusions.