Epilepsy and gut and mouth bacteria: linking microbiota to seizure medicine response
EPIGUT: EPILEPSY AND GASTROINTESTINAL MICROBIOTA: UNDERSTANDING THERAPY RESPONSE
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 |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 2 Years to 79 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 6 sites (Gothenburg and 5 other locations) |
| Trial ID | NCT07253701 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Gothenburg and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.