Clinical trial NCT04063007: Epigenetics and Gut Microbiota in Children With Epilepsy
Official title: The Potential Impact of the Ketogenic Diet on Epigenetics and Gut Microbiota in Children With Epilepsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Life Sciences
name: University of Oslo
name: Lund University
First posted: 2019-08-20
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, non-randomized study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Characterization of the gut microbiota
timeFrame: From baseline to 12 weeks of dietary treatment.
measure: Characterization of DNA methylation
timeFrame: From baseline to 12 weeks of dietary treatment.
Secondary outcomes:
measure: Changes in parental quality of life and parental perceptions of their child's quality of life
timeFrame: 12 weeks of dietary treatment.
measure: Adverse effects
timeFrame: 12 weeks of dietary treatment.
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Kaja K Selmer, PhD
role: PRINCIPAL_INVESTIGATOR
References: