The Efficacy of Ketogenic Diet in Treating Pediatric Intractable Epilepsy and Its Relationship With Changes in Inflammatory Markers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Epilepsy Control Response Rate
研究概览
简要总结
This study aims to evaluate the efficacy of a ketogenic diet in treating pediatric intractable epilepsy and to explore its relationship with changes in inflammatory markers. The investigators plan to recruit 59 participants with intractable epilepsy, 39 of whom will receive a combination of ketogenic diet and conventional antiepileptic drugs, while 20 will receive only conventional drugs. The study will assess the impact of the ketogenic diet on epilepsy control and inflammatory markers, hoping to discover new treatment strategies.
详细描述
Evaluation index
- Safety: Adverse events related to the ketogenic diet
- Efficacy evaluation:
A. Primary efficacy indicators: brain electrical load index, epilepsy control response rate, inflammatory factor 34 (blood, cerebrospinal fluid) Secondary efficacy indicators: epilepsy seizure-free rate B. Inspection indicators: blood ketone, blood sugar, blood biochemistry testing, etc.; C. Use high-throughput methods to detect absolute counts of cerebrospinal fluid, serum inflammatory factors, and whole blood lymphocyte subpopulations before and after adding a ketogenic diet.
Observation indicators
- Measurement of ketone body levels Monitor blood ketones (beta-hydroxybutyrate) and blood ketones. Recording time: Record three times a day during the baseline period; record the average blood ketone value at each subsequent follow-up observation.
- Frequency of epileptic seizures The frequency of epileptic seizures was recorded daily during the start-up period.
- Efficacy evaluation:
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
- None
入排标准
- 年龄范围
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 months to 12 years with a diagnosis of intractable epilepsy
- •more than four seizures per month
- •no metabolic diseases
- •no severe liver or kidney dysfunction.
排除标准
- •Fat metabolism or other metabolic diseases
- •febrile or infectious periods
- •contraindications to the ketogenic diet
- •children suitable for surgery or parents refusing drug and diet intervention.
研究组 & 干预措施
Ketogenic Diet plus Conventional Treatment Group
This arm of the trial explores the efficacy of an early initiation of the ketogenic diet in conjunction with conventional antiepileptic drugs (AEDs) for children with refractory epilepsy. The intervention aims to evaluate the impact on seizure frequency, and inflammatory markers, and identify patient characteristics predicting a better response to the ketogenic diet, to improve overall therapeutic response rates in refractory epilepsy.
干预措施: Early ketogenic diet combined with conventional pharmacotherapy. (Dietary Supplement)
Ketogenic Diet plus Conventional Treatment Group
This arm of the trial explores the efficacy of an early initiation of the ketogenic diet in conjunction with conventional antiepileptic drugs (AEDs) for children with refractory epilepsy. The intervention aims to evaluate the impact on seizure frequency, and inflammatory markers, and identify patient characteristics predicting a better response to the ketogenic diet, to improve overall therapeutic response rates in refractory epilepsy.
干预措施: Common diet combined with conventional pharmacotherapy (Drug)
Control Group: Conventional Treatment Group
Participants in this arm will receive a standard diet without any ketogenic restrictions, alongside conventional antiepileptic drugs. This comparator aims to assess the standard care's efficacy against the experimental intervention, focusing on seizure control, inflammatory markers, and identifying patient characteristics associated with treatment responsiveness.
干预措施: Early ketogenic diet combined with conventional pharmacotherapy. (Dietary Supplement)
Control Group: Conventional Treatment Group
Participants in this arm will receive a standard diet without any ketogenic restrictions, alongside conventional antiepileptic drugs. This comparator aims to assess the standard care's efficacy against the experimental intervention, focusing on seizure control, inflammatory markers, and identifying patient characteristics associated with treatment responsiveness.
干预措施: Common diet combined with conventional pharmacotherapy (Drug)
结局指标
主要结局
Epilepsy Control Response Rate
时间窗: During the study period (16 weeks)
Epilepsy control response rate: defined as an absolute reduction of ≥50% in seizure frequency at follow-up compared with baseline =(No attack + Marked effect + Effective)/Total number of cases × 100%.
次要结局
- Inflammatory Marker Levels(During the study period (16 weeks)])