Drug-Resistant EpilepsyEpiketoNCT07878104
Modified Ketogenic Diet on Drug-Resistant Epilepsy in Adults - a Prospective Observational Study of Real-world Data
A study testing Modified ketogenic diet in people with Drug-Resistant Epilepsy, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of our study is to investigate how dietary treatment with a modified ketogenic diet for patients with drug-resistant epilepsy affects patients' health-related quality of life and seizure frequency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug-Resistant Epilepsy
- What is being tested?
- Modified ketogenic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 10 Oct 2025to Dec 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Drug-resistant epilepsy (seizures not adequately controlled despite two or more antiepileptic drugs at adequate doses)
- Historical seizure frequency of six or more per year
Who cannot join
- Lack of motivation to treatment with modified ketogenic diet
- Severe psychiatric comorbidity , dementia, or severe functional impairment impacting adherence without a next of kin for support with diet.
- Pregnancy
- Type 1 Diabetes
- Gallbladder disease
- Liver disease
Show all 9Show fewer
- Metabolic disease
- Kidney disease
- Body mass index (BMI) below 19
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of our study is to investigate how dietary treatment with a modified ketogenic diet for patients with drug-resistant epilepsy affects patients' health-related quality of life and seizure frequency. We will also examine the diet's impact on cognitive functions, sleep, treatment side effects, microbiota metabolites, inflammation, and changes in the gut and oral bacterial flora, as well as the long-term aspects of this dietary treatment.
Read the detailed description
This study is a prospective, observational investigation into the clinical routine of using a modified ketogenic diet for adult patients with drug-resistant epilepsy (DRE) and the impact health-related quality of life of the patients, and reducing seizure frequency. The study will also explore the diet's impact on patients' cognitive functions, metabolic, inflammatory, gut and oral microbiota profiles to identify potential predictors of treatment success, and cost-efficiency in Sweden. The study aligns with established clinical routines from children's neurology in Sweden and global guidelines regarding adults. Patients will serve as their own controls, with baseline data collected during an initial period on a normal diet.
Run-in Period: A three-month period where participants maintain their normal diet while continuously logging seizures.
Intervention Phase: Participants will start a modified ketogenic diet for at least three months, with the active treatment phase lasting a maximum of two years. Patients will be followed up at 3, 6, 12, 24 and 36 months after inclusion in the study.
Dietary Protocol: The diet is high in fat and protein and low in carbohydrates. Participants are instructed to eat three to five meals a day, drink at least 2 liters of water daily, and take multivitamin, calcium, and vitamin D supplements.
Dietary Data Collection: The validated nutritional software NutritionData will be used for dietary registration, allowing patients to log food intake via a web interface or app. A photo-scan feature will also be used for documentation.
Long-Term Follow-up and Registry data: At three, five, and ten years, Swedish national registries will be used to explore outcomes such as cardiovascular comorbidities, survival and healthcare consumption.
Outcome Measures are Health-related Quality of Life: The Quality of Life in Epilepsy-31 (QOLIE-31) and Seizure Frequency: Continuous seizure registration via diaries and a web-based form. Outcomes are categorized as non-responder, responder (≥50% or ≥30% reduction). Seizure-freedom will also be observed.
The study will also explore:
Sleep and Cognitive Functions: The Karolinska Sleep Questionnaire (KSQ) will measure sleep difficulties and quality. Neuropsychological assessments will be done to analyze cognitive functions; verbal fluency, executive function, and memory etc.
Side Effects and levels of medications will be monitored clinically and through questionnaires. Blood tests will objectively track changes in medical levels, lipid levels, metabolic status, and organ function. For long-term side effects such as cardiovascular comorbidity and survival national registers will be used.
Biological Sample Collection
Biological samples (blood, cerebrospinal fluid, saliva, and feces) will be collected at each check-up point and biobanked for various analyses:
Blood Samples: Routine blood draws at each check-up point will monitor potential side effects and measure antiepileptic drug levels. Biobanked samples will be analyzed for inflammatory and metabolic profiles, and human gene variants of drug-metabolizing enzymes. Biobanked samples will also be stored for future analysis.
Voluntary Samples (Saliva and Feces): These will be collected to study the impact of the dietary treatment on the gut microbiota using high-throughput sequencing. Exploring proteomics as a potential research field in epilepsy and DRE and analyses using metagenomics, machine learning and metabolomics to find links between the microbiota and treatment outcomes.
Cerebrospinal Fluid (CSF): If collected as part of routine clinical practice, CSF will be analyzed for inflammatory and metabolic profiles.
The aim is to use advanced bioinformatics and machine learning to identify microbial predictors of seizures and therapy outcomes. All samples will be stored at the Stockholm Medical Biobank, and patients can request their samples be anonymized or destroyed at any time.
- Conditions
- Drug-Resistant Epilepsy
- Being tested
- Modified ketogenic diet
- Keywords
- Ketogenic diet
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified ketogenic dietOther
Modified ketogenic diet with a run-in period of three months on normal diet
| Study group | Role | What they receive |
|---|---|---|
| Modified ketogenic diet | Other | Modified ketogenic diet with a run-in period of three months on normal diet Receives: Other: Modified ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related Quality of Life
The Quality of Life in Epilepsy-31 (QOLIE-31), a self-reported epilepsy-specific measure.
Measured: Assessment at three and six months on modified ketogenic diet compared to run-in period of three months on normal diet
Seizure Frequency
Seizure frequency at three and six months on modified ketogenic diet compared to a run-in period of three months on normal diet
Measured: Seizure frequency at three and six months on modified ketogenic diet compared to a run-in period of three months on normal diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start10 Oct 2025
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-Resistant EpilepsyStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Ann-Sofie Rudberg, Karolinska Institutet
- Investigators
- Ann-Sofie Rudberg, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878104
- Sponsor's protocol ID
- EC approval no: 2025-04386-01
- Other IDs
- Epiketo
- Acronym
- Epiketo
- Status last verified
- Oct 2026
- First submitted
- 18 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depending on source of data
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Ketogenic Diet on Drug-Resistant Epilepsy in Adults - a Prospective Observational Study of Real-world Data
- ClinicalTrials.gov ID
- NCT07878104
- Acronym / sponsor ID
- Epiketo / EC approval no: 2025-04386-01
- Conditions
- Drug-Resistant Epilepsy
- Keywords
- Ketogenic diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 16 Oct 2026 (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 purpose of our study is to investigate how dietary treatment with a modified ketogenic diet for patients with drug-resistant epilepsy affects patients' health-related quality of life and seizure frequency. We will also examine the diet's impact on cognitive functions, sleep, treatment side effects, microbiota metabolites, inflammation, and changes in the gut and oral bacterial flora, as well as the long-term aspects of this dietary treatment.
Detailed description
This study is a prospective, observational investigation into the clinical routine of using a modified ketogenic diet for adult patients with drug-resistant epilepsy (DRE) and the impact health-related quality of life of the patients, and reducing seizure frequency. The study will also explore the diet's impact on patients' cognitive functions, metabolic, inflammatory, gut and oral microbiota profiles to identify potential predictors of treatment success, and cost-efficiency in Sweden. The study aligns with established clinical routines from children's neurology in Sweden and global guidelines regarding adults. Patients will serve as their own controls, with baseline data collected during an initial period on a normal diet.
Run-in Period: A three-month period where participants maintain their normal diet while continuously logging seizures.
Intervention Phase: Participants will start a modified ketogenic diet for at least three months, with the active treatment phase lasting a maximum of two years. Patients will be followed up at 3, 6, 12, 24 and 36 months after inclusion in the study.
Dietary Protocol: The diet is high in fat and protein and low in carbohydrates. Participants are instructed to eat three to five meals a day, drink at least 2 liters of water daily, and take multivitamin, calcium, and vitamin D supplements.
Dietary Data Collection: The validated nutritional software NutritionData will be used for dietary registration, allowing patients to log food intake via a web interface or app. A photo-scan feature will also be used for documentation.
Long-Term Follow-up and Registry data: At three, five, and ten years, Swedish national registries will be used to explore outcomes such as cardiovascular comorbidities, survival and healthcare consumption.
Outcome Measures are Health-related Quality of Life: The Quality of Life in Epilepsy-31 (QOLIE-31) and Seizure Frequency: Continuous seizure registration via diaries and a web-based form. Outcomes are categorized as non-responder, responder (≥50% or ≥30% reduction). Seizure-freedom will also be observed.
The study will also explore:
Sleep and Cognitive Functions: The Karolinska Sleep Questionnaire (KSQ) will measure sleep difficulties and quality. Neuropsychological assessments will be done to analyze cognitive functions; verbal fluency, executive function, and memory etc.
Side Effects and levels of medications will be monitored clinically and through questionnaires. Blood tests will objectively track changes in medical levels, lipid levels, metabolic status, and organ function. For long-term side effects such as cardiovascular comorbidity and survival national registers will be used.
Biological Sample Collection
Biological samples (blood, cerebrospinal fluid, saliva, and feces) will be collected at each check-up point and biobanked for various analyses:
Blood Samples: Routine blood draws at each check-up point will monitor potential side effects and measure antiepileptic drug levels. Biobanked samples will be analyzed for inflammatory and metabolic profiles, and human gene variants of drug-metabolizing enzymes. Biobanked samples will also be stored for future analysis.
Voluntary Samples (Saliva and Feces): These will be collected to study the impact of the dietary treatment on the gut microbiota using high-throughput sequencing. Exploring proteomics as a potential research field in epilepsy and DRE and analyses using metagenomics, machine learning and metabolomics to find links between the microbiota and treatment outcomes.
Cerebrospinal Fluid (CSF): If collected as part of routine clinical practice, CSF will be analyzed for inflammatory and metabolic profiles.
The aim is to use advanced bioinformatics and machine learning to identify microbial predictors of seizures and therapy outcomes. All samples will be stored at the Stockholm Medical Biobank, and patients can request their samples be anonymized or destroyed at any time.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified ketogenic diet | Other | Other: Modified ketogenic dietModified ketogenic diet with a run-in period of three months on normal diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older.
- Drug-resistant epilepsy (seizures not adequately controlled despite two or more antiepileptic drugs at adequate doses)
- Historical seizure frequency of six or more per year
Key exclusion criteria (9 listed)
- Lack of motivation to treatment with modified ketogenic diet
- Severe psychiatric comorbidity , dementia, or severe functional impairment impacting adherence without a next of kin for support with diet.
- Pregnancy
- Type 1 Diabetes
- Gallbladder disease
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 |
|---|---|---|
| Modified ketogenic dietModified ketogenic diet with a run-in period of three months on normal diet | Other | Modified ketogenic diet |
Primary outcome
Health-related Quality of Life
Time frame: Assessment at three and six months on modified ketogenic diet compared to run-in period of three months on normal diet
The Quality of Life in Epilepsy-31 (QOLIE-31), a self-reported epilepsy-specific measure.
Seizure Frequency
Time frame: Seizure frequency at three and six months on modified ketogenic diet compared to a run-in period of three months on normal diet
Seizure frequency at three and six months on modified ketogenic diet compared to a run-in period of three months on normal diet
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Undecided. Depending on source of data
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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.
Ann-Sofie Rudberg, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified ketogenic diet in people with Drug-Resistant Epilepsy, run by Karolinska Institutet at 1 site in Sweden.
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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ann-Sofie Rudberg, MD, PhD (+46 8 123 55000, ann-sofie.rudberg@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related Quality of Life (time frame: Assessment at three and six months on modified ketogenic diet compared to run-in period of three months on normal diet). 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 16 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.