MiCrobiota-gut-brain Axis in Resistant Epilepsy

Recruiting now · Not applicable

Conditions studied: Gut Microbiota, Epilepsy, Drug-Resistant Epilepsy

In brief

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 facts

Study ID

NCT07010445

Run by

Niguarda Hospital

People needed

120

Starts

2024-08-16

Expected to finish

2027-02-01

Last updated by the study team

2026-04-09

Who can join

Age: 3 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 3-50 years old;
• diagnosis of epilepsy at onset or DRE;
• ensured participation of the patient or a caregiver;
• willingness to sign the informed consent.

You may not qualify if…

• diagnosis of organic gastrointestinal disorders (e.g. chronic inflammatory bowel disease);
• special diets;
• use of antibiotics, corticoids or probiotics in the previous month.

Where it is running

• ASST GOM Niguarda — Milan, Lombardy, Italy (enrolling)

Full record on ClinicalTrials.gov

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