Leveraging the Gut Microbiota in Pediatric Refractory Epilepsy: Safety and Feasibility of Oligofructose-enriched Inulin Supplementation for Dysbiosis and Seizure Control
试验速览
- 阶段
- 4 期
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Change in alpha and beta bacterial diversity measures in stool
研究概览
简要总结
Nearly a third of children with epilepsy are refractory to pharmacotherapy. The ketogenic diet (KD) is a highly effective alternative therapy reducing seizure frequency by 50% in more than half of treated children. The exact mechanisms of KD remain poorly understood, and recent studies have implicated the gut microbiota (GM). This pilot study aims to determine the feasibility of a 12-week dietary intervention with prebiotic fiber in children with epilepsy. The investigators hypothesize that consumption of inulin will alter gut microbiota and may have effects on seizure frequency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children with epilepsy:
- •Attended the epilepsy clinic for a minimum of 6 months.
- •On a stable number and type of medications for 4 weeks.
- •Have not previously been on the ketogenic diet.
- •Healthy controls:
- •Immunocompetent.
- •No medical comorbidities (e.g. autoimmune, metabolic, cardiovascular, renal, or gastrointestinal conditions).
排除标准
- •Health conditions such as disorders of fatty acid transport and oxidation, porphyria, and pancreatitis, Glucose transporter 1 deficiency, pyruvate dehydrogenase deficiency, diabetes, and other autoimmune diseases.
- •Presence of HIV infection, chronic wound infection, or osteomyelitis
- •Presence of or treatment for periodontal infection
- •Inflammatory bowel disease, chronic diarrhea, current Clostridium difficile infection
- •Treatment with immunosuppressive agents in the past 6 months
- •Significant changes in dietary intake (i.e. excluded sugar, lactose or gluten from their diet, started consuming a vegetarian or vegan diet) over the past 6 months.
- •Gastrointestinal illness in the past month or food intolerances leading to gastrointestinal symptoms.
- •Use of antibiotics in the 3 months preceding the study.
- •Use of probiotic or prebiotic supplements in the month preceding the study.
- •Consumption of probiotic yoghurt in the past 2 weeks.
- •Use of laxatives, proton pump inhibitors, or gastric motility medications in the month preceding the study.
- •History of allergic reaction or intolerance of maltodextrin or inulin.
结局指标
主要结局
Change in alpha and beta bacterial diversity measures in stool
时间窗: 12 weeks
Compare the effect of oral inulin vs. placebo on alpha and beta bacterial diversity in the stool of children undergoing ketogenic diet therapy for epilepsy
Change in Short Chain Fatty Acid (SCFA) levels in stool
时间窗: 12 weeks
Compare the effect of inulin vs. placebo on SCFA levels in the stool of children undergoing ketogenic diet therapy for epilepsy
次要结局
- Seizure frequency(12 weeks)
研究者
Maksim Parfyonov
Resident, Division of Neurology
British Columbia Children's Hospital