Epigenetics and Gut Microbiota in Children With Epilepsy (EpiMICRO)
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
60 participants in 1 patient group
Trial contacts and locations
Loading...
Central trial contact
Sigrid Pedersen, MSc; Kaja K Selmer, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal