Epigenetics and Gut Microbiota in Children With Epilepsy (EpiMICRO)
Primary Purpose
Epilepsy
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Ketogenic diet
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy
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
Sites / Locations
- Oslo University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Ketogenic diet
Arm Description
The patients follow the ordinary treatment protocol for initiation and follow-up of the ketogenic diet
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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)
Adverse effects
To identify potential adverse effects induced by the dietary treatment measured by a structured interview.
Full Information
NCT ID
NCT04063007
First Posted
November 11, 2018
Last Updated
September 19, 2022
Sponsor
Oslo University Hospital
Collaborators
Norwegian University of Life Sciences, University of Oslo, Lund University
1. Study Identification
Unique Protocol Identification Number
NCT04063007
Brief Title
Epigenetics and Gut Microbiota in Children With Epilepsy
Acronym
EpiMICRO
Official Title
The Potential Impact of the Ketogenic Diet on Epigenetics and Gut Microbiota in Children With Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Norwegian University of Life Sciences, University of Oslo, Lund University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective, non-randomized study
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ketogenic diet
Arm Type
Other
Arm Description
The patients follow the ordinary treatment protocol for initiation and follow-up of the ketogenic diet
Intervention Type
Other
Intervention Name(s)
Ketogenic diet
Intervention Description
The patients follow the ordinary treatment protocol for ketogenic diet
Primary Outcome Measure Information:
Title
Characterization of the gut microbiota
Description
Changes in the gut microbiota composition in fecal samples from baseline to 12 weeks of dietary treatment will be measured by 16S rRNA analysis.
Time Frame
From baseline to 12 weeks of dietary treatment.
Title
Characterization of DNA methylation
Description
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.
Time Frame
From baseline to 12 weeks of dietary treatment.
Secondary Outcome Measure Information:
Title
Changes in parental quality of life and parental perceptions of their child's quality of life
Description
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)
Time Frame
12 weeks of dietary treatment.
Title
Adverse effects
Description
To identify potential adverse effects induced by the dietary treatment measured by a structured interview.
Time Frame
12 weeks of dietary treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kaja K Selmer, PhD
Phone
0047 22 11 77 83
Email
k.k.selmer@medisin.uio.no
First Name & Middle Initial & Last Name or Official Title & Degree
Sigrid Pedersen, MSc
Phone
004767501491
Email
ketoprosjekt@ous-hf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaja K Selmer, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaja K Selmer, PhD
Phone
004722117783
Email
k.k.selmer@medisin.uio.no
First Name & Middle Initial & Last Name & Degree
Sigrid Pedersen, MSc
Phone
004767501491
Email
ketoprosjekt@ous-hf.no
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Epigenetics and Gut Microbiota in Children With Epilepsy
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