ObjectiveThe purpose of this study was to find a new method for the treatment of drug-resistant epilepsy, and to study the efficacy and safety of Bacteroidesfragilis (BF839) in the adjunctive treatment of refractory epilepsy, as well as the improvement of comorbidity.MethodsA prospective, single-arm, open pilot clinical study was designed for the additive treatment of drug-resistant epilepsy using BacteroidesFragilis 839 (BF839). 47 patients with refractory epilepsy, who were admitted to the epilepsy outpatient clinic of the Second Affiliated Hospital of Guangzhou Medical University from April 2019 to October 2019, were enrolled and treated with BF839 adjunct treatment. The primary efficacy endpoint was median percent reduction from baseline in monthly (28-day) seizure frequency for the 16-week treatment period. Other efficacy analysis included response rate(proportion of patients with ≥ 50% seizure reduction) in the 16 weeks period, the proportion of patients seizure free and the retention rate after12 months intervention, and the observance of the side effects and comorbidities.ResultsThe median reduction percent of all seizure types was −53.5% (P=0.002). The response rate was 61.1% (22/36). 8.5% (4/47) patients seizure free at 12 months. The retention rate at 12 months was 57.4% (27/47). The side effects were diarrhea 4.3% (2/47) and constipation 4.3% (2/47). 48.9% (23/47) of the patients reported improvement in comorbidities, with cognitive improvement of 21.2% (10/47).ConclusionBF839 can be used as an effective additive therapy to treat drug-resistant epilepsy. It is safe and beneficial to the improvement of comorbidities. This is the first time in the world that a single intestinal strain has been reported to be effective in treating drug-resistant epilepsy. This research has important implications.
The correlation between gut microbes and epilepsy is a hot research topic. This review aims to summarize the effects of Ketogenic diet (KD) on gut microbes and the preclinical and clinical progress of the use of Fecal microbiota transplants (FMT) and Probiotics in the intervention of epilepsy to provide clinical reference. Gut microbes mediates the antiepileptic effect of KD. Many studies have found that bactericides decreased in epileptic patients, and KD can increase bactericides abundance, which may be one of its effective mechanisms. Both FMT and probiotics showed antiepileptic effects on epileptic model mice with different pathogenesis, suggesting that gut microbes is an important target for epilepsy treatment. Preliminary clinical studies of small samples suggest that the use of probiotics can effectively treat refractory epilepsy and autoimmune-associated epilepsy, and can improve comorbidities. No serious and long-term side effects of probiotics have been found in epileptic patients. In the future, more high-quality studies are needed to further clarify its efficacy and mechanisms, which could lead to new strategies for epilepsy treatment and refresh our understanding of the causes of epilepsy.
ObjectiveTo retrospectively analyze patients taking Bacteroides fragilis (BF839) alone for their "possible autoimmune-related epilepsy" to find new treatments for epilepsy. Methods15 newly diagnosed patients who were not treated with standard Anti-seizure medications were diagnosed with "possible autoimmune-related epilepsy" and were given oral BF839 to initiate treatment. Seizure changes, self-reported improvement of comorbidities, EEG, adverse reactions and other information were reviewed. ResultsDuring the follow-up period of 14~33 months, 73.33% (11/15) patients achieved 1-year remission during the follow-up period, 7 patients had a remission time of more than 24 months, and 4 patients had a remission time of more than 30 months. 73.33% (11/15) of the patients reported that their comorbidities improved, and the EEG improvement rate was 57.14% (4/7). No patients withdrew due to adverse reactions, and the 12-month retention rate was 73.33% (11/15).ConclusionIt is the first report that the early application of intestinal flora preparation alone can effectively treat “possible autoimmune-related epilepsy”, and it can also be used as a diagnostic treatment tool due to its lower adverse reactions and improvement of comorbidities. This is not only of great significance to significantly improve the early diagnosis rate and remission rate of autoimmune-related epilepsy, and to prevent patients from developing refractory epilepsy, but also refreshes our understanding of the etiology of epilepsy.