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

RecruitingNAAges 18 Years - anyAllKarolinska Institutet
NCT07878104 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Modified ketogenic diet
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Where

1 site
Karolinska Institutet
Stockholm, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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