The Potential Impact of the Ketogenic Diet on Epigenetics and Gut Microbiota in Children With Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Characterization of DNA methylation
研究概览
简要总结
The ketogenic diet is a high-fat, low-carbohydrate diet used in the treatment of epilepsy. The diet can be an efficient treatment option in children with drug resistant epilepsy, with more than 50 % seizure reduction in about 40- 70 % of the patients. However, there is still a lack of knowledge regarding the mechanisms of action, how will respond to the treatment and potential adverse effects.
详细描述
The ketogenic diet is a high-fat, moderate protein, low-carbohydrate diet. It is an internationally established treatment option in children with drug resistant epilepsy. About 40 -70 % of children with drug resistant epilepsy treated with the ketogenic diet achieve > 50 % seizure reduction. However, even though the ketogenic diet has been used in the treatment of epilepsy for almost a Century, little is known about how the dietary treatment reduces seizures and which patients that will respond well. In addition, there is limited knowledge about potential adverse effects of the treatment. This is a prospective study following the patients from 4 weeks before initiating the ketogenic diet and during the treatment. The influence of the dietary treatment on the gut microbiota, epigenetics, quality of life, and adverse effects will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Drug resistant epilepsy
- •Age 2- 17 years
- •Two or more countable seizures/week
- •Willing to try treatment with the ketogenic diet for at least 12 weeks
排除标准
- •Glucose transporter protein 1 deficiency, pyruvate dehydrogenase deficiency, or pyruvate carboxylase deficiency
- •Known or suspected disease in wich the diet is contraindicated
- •Epilepsy surgery the last 6 months before diet initiation
- •Steroid medications the last 2 months before diet initiation
- •Breastfeeding
- •Psychogenic non-epileptic seizures
- •Eating disorder
- •Pregnancy or planed pregnancy
- •Feeding disabilities not compatible with dietary treatment
- •Inability to follow study scheme
- •Previous treatment with high-fat, low- carbohydrate diet
- •Medical need to start dietary treatment immediately
结局指标
主要结局
Characterization of DNA methylation
时间窗: From baseline to 12 weeks of dietary treatment.
Changes in the DNA methylation in white blood cells from baseline to 12 weeks of dietary treatment will be analyzed using the Infinium Methylation EPIC Kit.
Characterization of the gut microbiota
时间窗: From baseline to 12 weeks of dietary treatment.
Changes in the gut microbiota composition in fecal samples from baseline to 12 weeks of dietary treatment will be measured by 16S rRNA analysis.
次要结局
- Changes in parental quality of life and parental perceptions of their child's quality of life(12 weeks of dietary treatment.)
- Adverse effects(12 weeks of dietary treatment.)
研究者
Kaja Kristine Selmer
Senior Scientist, MD, PhD
Oslo University Hospital