Epigenetics and Gut Microbiota in Children With Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-15

Study Completion Date

2022-11-01

Brief Summary

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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.

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Detailed Description

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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

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Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a prospective, non-randomized study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ketogenic diet

The patients follow the ordinary treatment protocol for initiation and follow-up of the ketogenic diet

Group Type OTHER

Ketogenic diet

Intervention Type OTHER

The patients follow the ordinary treatment protocol for ketogenic diet

Interventions

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Ketogenic diet

The patients follow the ordinary treatment protocol for ketogenic diet

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No