Epilepsy
Conditions
Brief summary
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.
Detailed 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.
Interventions
OTHERKetogenic diet
The patients follow the ordinary treatment protocol for ketogenic diet
Sponsors
Norwegian University of Life Sciences
University of Oslo
Lund University
Oslo University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, non-randomized study
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterization of the gut microbiota | 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. |
| Characterization of DNA methylation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in parental quality of life and parental perceptions of their child's quality of life | 12 weeks of dietary treatment. | The impact of the dietary treatment on quality of life will be examined by using a questionaire before and after 12 weeks of dietary treatment. The quality of life score is a parental measure of the impact for the family, based on their hopes and expectations of the effects of the ketogenic diet.The quality of life is rate on a scale from 0 to 10 (0 = quality of life is poor, 10 = quality of life is very good) |
| Adverse effects | 12 weeks of dietary treatment. | To identify potential adverse effects induced by the dietary treatment measured by a structured interview. |
Countries
Norway
Contacts
Primary ContactKaja K Selmer, PhD
Backup ContactSigrid Pedersen, MSc
Outcome results
None listed