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Epigenetics and Gut Microbiota in Children With Epilepsy (EpiMICRO)

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ClinicalTrials.gov Identifier: NCT04063007
Recruitment Status : Recruiting
First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Collaborators:
Norwegian University of Life Sciences
University of Oslo
Lund University
Information provided by (Responsible Party):
Kaja Kristine Selmer, Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE November 11, 2018
First Posted Date  ICMJE August 20, 2019
Last Update Posted Date August 20, 2019
Actual Study Start Date  ICMJE August 15, 2017
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2019)
  • Characterization of the gut microbiota [ Time Frame: 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.
  • Characterization of DNA methylation [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2019)
  • Quality of life [ Time Frame: 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)
  • Adverse effects [ Time Frame: 12 weeks of dietary treatment. ]
    To identify potential adverse effects induced by the dietary treatment measured by a structured interview.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Epigenetics and Gut Microbiota in Children With Epilepsy
Official Title  ICMJE The Potential Impact of the Ketogenic Diet on Epigenetics and Gut Microbiota in Children With Epilepsy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
This is a prospective, non-randomized study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE Other: Ketogenic diet
The patients follow the ordinary treatment protocol for ketogenic diet
Study Arms  ICMJE Ketogenic diet
The patients follow the ordinary treatment protocol for initiation and follow-up of the ketogenic diet
Intervention: Other: Ketogenic diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 19, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kaja K Selmer, PhD 0047 22 11 77 83 k.k.selmer@medisin.uio.no
Contact: Sigrid Pedersen, MSc 004767501491 ketoprosjekt@ous-hf.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04063007
Other Study ID Numbers  ICMJE 2016/2016/REK sør-øst
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Kaja Kristine Selmer, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE
  • Norwegian University of Life Sciences
  • University of Oslo
  • Lund University
Investigators  ICMJE
Principal Investigator: Kaja K Selmer, PhD Oslo University Hospital
PRS Account Oslo University Hospital
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP