EpilepsyEpiMICRONCT04063007
Epigenetics and Gut Microbiota in Children With Epilepsy
A study testing Ketogenic diet in people with Epilepsy, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Ketogenic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 15 Aug 2017to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, 0424
Kaja K Selmer, PhD, 004722117783, k.k.selmer@medisin.uio.no
Sigrid Pedersen, MSc, 004767501491, ketoprosjekt@ous-hf.no
About this study
Official title: The Potential Impact of the Ketogenic Diet on Epigenetics and Gut Microbiota in Children With Epilepsy
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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Ketogenic diet
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietOther
The patients follow the ordinary treatment protocol for ketogenic diet
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic diet | Other | The patients follow the ordinary treatment protocol for initiation and follow-up of the ketogenic diet Receives: Other: Ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 12 weeks of dietary treatment.
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.
Measured: From baseline to 12 weeks of dietary treatment.
Secondary outcomes (2)
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)
Measured: 12 weeks of dietary treatment.
Adverse effects
To identify potential adverse effects induced by the dietary treatment measured by a structured interview.
Measured: 12 weeks of dietary treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start15 Aug 2017
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, non-randomized study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Life Sciences, University of Oslo, Lund University
- Responsible party
- Principal investigator, Kaja Kristine Selmer, Oslo University Hospital
- Investigators
- Kaja K Selmer, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063007
- Sponsor's protocol ID
- 2016/2016/REK sør-øst
- Acronym
- EpiMICRO
- Status last verified
- Sep 2022
- First submitted
- 11 Nov 2018
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Impact of the Ketogenic Diet on Epigenetics and Gut Microbiota in Children With Epilepsy
- ClinicalTrials.gov ID
- NCT04063007
- Acronym / sponsor ID
- EpiMICRO / 2016/2016/REK sør-øst
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Life Sciences, University of Oslo, Lund University
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, non-randomized study
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet | Other | Other: Ketogenic dietThe patients follow the ordinary treatment protocol for initiation and follow-up of the ketogenic diet |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic dietThe patients follow the ordinary treatment protocol for ketogenic diet | Other | Ketogenic diet |
Primary outcome
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.
2 secondary outcomes
Changes in parental quality of life and parental perceptions of their child's quality of life
Time frame: 12 weeks of dietary treatment.
Adverse effects
Time frame: 12 weeks of dietary treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaja K Selmer, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic diet in people with Epilepsy, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kaja K Selmer, PhD (0047 22 11 77 83, k.k.selmer@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of the gut microbiota (time frame: From baseline to 12 weeks of dietary treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.