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MiCrobiota-gut-brain Axis in Resistant Epilepsy
Sponsor: Niguarda Hospital
Summary
Epilepsy is one of the most common neurological chronic conditions with a serious burden on patients, their caregivers, and society. Drug-resistant epilepsy (DRE) heightens this burden. New approaches are thus a priority. Studies in animal models and humans have shown the link between gut microbiota (GM) and the central nervous system in health, neurological conditions, and neurodevelopmental disorders. DRE has been linked to GM dysbiosis. Preliminary findings in children with DRE showed GM modifications when responding to a ketogenic diet. The mediator role of GM has not yet been studied in DRE patients undergoing surgery/vagal nerve stimulation. CARE's central hypothesis is that the GM and its metabolic profile could contribute to clinical outcomes following these different therapeutic procedures. Identifying microbial biomarkers will enable us to deepen the knowledge of the role of gut-brain axis in epilepsy and to tailor the intervention to each patient based on GM modulation.
Key Details
Gender
All
Age Range
3 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2024-08-16
Completion Date
2027-02
Last Updated
2026-04-09
Healthy Volunteers
No
Interventions
Naïve: epilepsy first diagnosis,
no intervention
DRE-surgery: resective surgery;
resective surgery
anti-epileptic drugs;
Anti-epileptic drugs,
DRE-VNS: vagal nerve stimulation;
vagal nerve stimulation
DRE-KD: ketogenic diet.
ketogenic diet.
Locations (1)
ASST GOM Niguarda
Milan, Lombardy, Italy