Epigenetics and Gut Microbiota in Children With Epilepsy

Epilepsy Clinical Trial

— EpiMICRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04063007
• Other study ID #: 2016/2016/REK sør-øst
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2017
• Est. completion date: November 1, 2022

Study information

• Verified date: September 2022
• Source: Oslo University Hospital
• Contact: Kaja K Selmer, PhD
• Phone: 0047 22 11 77 83
• Email: k.k.selmer[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• Ketogenic diet
The patients follow the ordinary treatment protocol for ketogenic diet

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
Oslo University Hospital	Lund University, Norwegian University of Life Sciences, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of the gut microbiota	Changes in the gut microbiota composition in fecal samples from baseline to 12 weeks of dietary treatment will be measured by 16S rRNA analysis.	From baseline to 12 weeks of dietary treatment.
Primary	Characterization of DNA methylation	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.	From baseline to 12 weeks of dietary treatment.
Secondary	Changes in parental quality of life and parental perceptions of their child's quality of life	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)	12 weeks of dietary treatment.
Secondary	Adverse effects	To identify potential adverse effects induced by the dietary treatment measured by a structured interview.	12 weeks of dietary treatment.