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RECRUITING Not applicable ClinicalTrials.gov

Modified Ketogenic Diet on Drug-Resistant Epilepsy in Adults - a Prospective Observational Study of Real-world Data

Sponsor: Karolinska Institutet • ClinicalTrials.gov ID: NCT07878104

Registry updated: 2026-10-16
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Description

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.

Interventions

  • Modified ketogenic diet (Other)
    Modified ketogenic diet with a run-in period of three months on normal diet

Eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Metabolic disease * Kidney disease * Body mass index (BMI) below 19

Conditions

Drug-Resistant Epilepsy

Locations

  • Karolinska Institutet — Stockholm, Sweden
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record