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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

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This 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 : August 15, 2017
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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)

  2. Adverse effects [ Time Frame: 12 weeks of dietary treatment. ]
    To identify potential adverse effects induced by the dietary treatment measured by a structured interview.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04063007


Contacts
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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

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Kaja K Selmer, PhD    004722117783    k.k.selmer@medisin.uio.no   
Contact: Sigrid Pedersen, MSc    004767501491    ketoprosjekt@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Norwegian University of Life Sciences
University of Oslo
Lund University
Investigators
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Principal Investigator: Kaja K Selmer, PhD Oslo University Hospital

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Responsible Party: Kaja Kristine Selmer, Senior Scientist, MD, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04063007     History of Changes
Other Study ID Numbers: 2016/2016/REK sør-øst
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases