MiCrobiota-gut-brain Axis in Resistant Epilepsy

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Gut Microbiota Changes — 1 - 6 - 12 months
  Gut microbiota composition and changes (at different levels: e.g. phyla, families, species) in groups of responders (e.g. seizure reduction \>50%,\>75% or 100% from baseline in monthly seizure counts) after 1,6, and 12 months of ASMs therapy or surgery, VNS and KD whenDRE;
• Gut Microbiota Biomarkers — 1,6, and 12 months
  Identification of specific biomarkers (e.g. changes in gut microbiota species) in groups of responders, that could help clinicians to choose the intervention with the most likelihood of improving patients quality if life (performance assessed when Area Under the Curve AUC \> 0.8).

Trial sites (1)

More Niguarda Hospital trials in Italy

Other trials for the same condition