An interventional study of Modified ketogenic diet in Drug-Resistant Epilepsy, sponsored by Karolinska Institutet. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Prevention
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.
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.
270 studies on the registry are indexed under Drug Resistant Epilepsy; 100 are open to participants now.
This study's planned enrollment of 150 is above the median of 30 across 213 interventional studies indexed under Drug Resistant Epilepsy.
Browse Drug Resistant Epilepsy studies →Karolinska Institutet is the lead sponsor of 1,145 studies on the registry; 274 are open to participants now.
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Exclusion Criteria:
Modified ketogenic diet with a run-in period of three months on normal diet
Other: Modified ketogenic diet
Modified ketogenic diet with a run-in period of three months on normal diet
Health-related Quality of Life
The Quality of Life in Epilepsy-31 (QOLIE-31), a self-reported epilepsy-specific measure.
Time frame: 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
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
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — Depending on source of data
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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