EpiMICRO: Epigenetics and Gut Microbiota in Children With Epilepsy

• Sponsor: Oslo University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04063007
• Collaborator: Norwegian University of Life Sciences (Other), University of Oslo (Other), Lund University (Other)
• Enrollment: 60
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 49.5
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Other: Ketogenic diet	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: This is a prospective, non-randomized studyThis is a prospective, non-randomized study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Potential Impact of the Ketogenic Diet on Epigenetics and Gut Microbiota in Children With Epilepsy
• Actual Study Start Date: Aug 15, 2017
• Anticipated Primary Completion Date: Jul 1, 2021
• Anticipated Study Completion Date: Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Ketogenic diet The patients follow the ordinary treatment protocol for initiation and follow-up of the ketogenic diet	Other: Ketogenic diet; The patients follow the ordinary treatment protocol for ketogenic diet

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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)

2. Adverse effects [12 weeks of dietary treatment.]

   To identify potential adverse effects induced by the dietary treatment measured by a structured interview.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo University Hospital	Oslo		Norway	0424

Sponsors and Collaborators

• Oslo University Hospital
• Norwegian University of Life Sciences
• University of Oslo
• Lund University

Investigators

• Principal Investigator: Kaja K Selmer, PhD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kaja Kristine Selmer, Senior Scientist, MD, PhD, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT04063007
• Other Study ID Numbers: 2016/2016/REK sør-øst
• First Posted: Aug 20, 2019
• Last Update Posted: Aug 20, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Epilepsy

Study Results

No Results Posted as of Aug 20, 2019