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UnknownNCT04063007

Epigenetics and Gut Microbiota in Children With Epilepsy

The Potential Impact of the Ketogenic Diet on Epigenetics and Gut Microbiota in Children With Epilepsy

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Oslo University Hospital · Academic / Other
Sex
All
Age
2 Years – 17 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERKetogenic dietThe patients follow the ordinary treatment protocol for ketogenic diet

Timeline

Start date
2017-08-15
Primary completion
2022-11-01
Completion
2022-11-01
First posted
2019-08-20
Last updated
2022-09-22

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT04063007. Inclusion in this directory is not an endorsement.