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Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Modified ketogenic diet for adults with drug-resistant epilepsy

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

Run by Karolinska Institutet · NCT07878104 · Data updated 2026-11-12

This study tests whether a modified ketogenic diet can help adults with drug-resistant epilepsy see fewer seizures and feel better overall.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment150 (estimated)
SponsorKarolinska Institutet
Academic / other
Locations1 site (Stockholm)
StatusRecruiting
StartedOctober 10, 2025
Main results expectedDecember 2035
Study endsDecember 2035
Registry record updatedOctober 16, 2026
Trial IDNCT07878104 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) with drug-resistant epilepsy and a history of six or more seizures per year, motivated to follow a modified ketogenic diet.

Probably not a fit

Individuals unable to adhere to the diet due to medical or psychosocial factors, or without adequate support, may not experience benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, observational study in adults with drug-resistant epilepsy to see how a modified ketogenic diet affects quality of life, seizure frequency, cognitive function, sleep, and potential biological changes. Participants serve as their own controls, with baseline data collected on their usual diet before starting the diet for at least three months and followed for up to 36 months. The study also explores metabolic, inflammatory, gut and oral microbiota profiles and cost considerations to identify predictors of response and the diet’s practicality in routine care in Sweden.

Why it matters

Potential benefit: If successful, participants may experience reduced seizure frequency and improved quality of life while providing data to guide real-world use of the diet.

How similar studies have gone: Previous pediatric and adult epilepsy research suggests dietary approaches can reduce seizures, but real-world observational data in adults is limited.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Karolinska Institutet
    Stockholm, Sweden     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.