Epilepsy and gut and mouth bacteria: linking microbiota to seizure medicine response
Official title: EPIGUT: EPILEPSY AND GASTROINTESTINAL MICROBIOTA: UNDERSTANDING THERAPY RESPONSE
Run by Karolinska Institutet · NCT07253701 · Data updated 2026-11-12
This project will test whether differences in gut and mouth bacteria are linked to epilepsy type and change how well seizure medicines work in people newly diagnosed with epilepsy compared with healthy volunteers.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 2 Years to 79 Years |
| Sex | All |
| Enrollment | 1500 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 6 sites (Gothenburg and 5 other locations) |
| Status | Recruiting |
| Started | February 27, 2024 |
| Main results expected | March 2028 |
| Study ends | March 2028 |
| Registry record updated | November 28, 2025 |
| Trial ID | NCT07253701 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 2–79 with newly diagnosed, treatment-naïve epilepsy who have not used antibiotics or probiotics in the past three months and who do not have major gastrointestinal disease or other listed exclusions.
✕Probably not a fit
People already taking anti-seizure medication, those who recently used antibiotics or probiotics, have major gastrointestinal surgeries or diagnoses, obesity (BMI > 30), type 2 diabetes, strict exclusion diets, pregnancy or breastfeeding, or feeding tubes are unlikely to benefit from enrolling.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
EpiGUT will enroll treatment-naïve people with newly diagnosed epilepsy and matched healthy controls and collect saliva and fecal samples to profile the oral and gut microbiota. Blood and CSF samples will be analyzed for metabolic and inflammatory markers to explore systemic and central pathways linking microbes to seizures and drug response. Participants will be followed longitudinally to see how baseline microbiota relate to later response to anti-seizure medications, and selected microbe–drug interactions will be tested in vitro. The goal is to identify microbial signatures and mechanisms that could inform personalized anti-seizure therapy.
Why it matters
Potential benefit: If successful, the findings could help personalize anti-seizure medication choices using a person's gut microbiota to reduce seizures or side effects.
How similar studies have gone: Animal studies and small human cohorts suggest the microbiota can affect seizure risk and drug response, but human evidence is limited and this larger longitudinal cohort is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients: Age 2-79 years, newly diagnosed with epilepsy, treatment-naive at time of enrollment * Controls: Age 2-79 years Exclusion Criteria: * Patients: already started ASM treatment (more then one dose), has used antibiotics or probiotics in the last three months, has a gastrointestinal diagnosis, has surgically removed parts of the GIT, obesity (BMI\>30), T2D, follows a strict exclusion diet, is pregnant or breastfeeding, has a gastrostomy, PEG or jejunostomy * Controls: previous epilepsy diagnosis or ASM treatment, has used antibiotics or probiotics in the last three months, has a gastrointestinal diagnosis, has surgically removed parts of the GIT, obesity (BMI\>30), T2D, follows a strict exclusion diet, is pregnant or breastfeeding, has a gastrostomy, PEG or jejunostomy
Where it's running
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Drottning Silvias Barnsjukhus
Gothenburg, Sweden Recruiting -
Universitetssjukhuset i Linköping
Linköping, Sweden Recruiting -
Skånes universitetssjukhus
Lund, Sweden Recruiting -
Karolinska Universitetssjukhus
Stockholm, Sweden Recruiting -
Norrlands universitetssjukhus
Umeå, Sweden Recruiting -
Akademiska Sjukhuset
Uppsala, Sweden Recruiting
Study contacts
- Study coordinator: Ronny Wickström, MD, PhD
- Email: ronny.wickstrom@ki.se
- Phone: +46 70 68 38 182
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.