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
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Other: Ketogenic diet||Not Applicable|
|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)|
|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|
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
- 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.
- 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.
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
|Contact: Kaja K Selmer, PhD||0047 22 11 77 firstname.lastname@example.org|
|Contact: Sigrid Pedersen, MScemail@example.com|
|Oslo University Hospital||Recruiting|
|Oslo, Norway, 0424|
|Contact: Kaja K Selmer, PhD 004722117783 firstname.lastname@example.org|
|Contact: Sigrid Pedersen, MSc 004767501491 email@example.com|
|Principal Investigator:||Kaja K Selmer, PhD||Oslo University Hospital|