MiCrobiota-gut-brain Axis in Resistant Epilepsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-50
SponsorNiguarda Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
diagnosis of organic gastrointestinal disorders (e.g. chronic inflammatory bowel disease);
special diets;
use of antibiotics, corticoids or probiotics in the previous month.
Trial design
Treatments tested in this trial
- Naïve: epilepsy first diagnosis,
- DRE-surgery: resective surgery;
- anti-epileptic drugs;
- DRE-VNS: vagal nerve stimulation;
- DRE-KD: ketogenic diet.
Treatment groups
120 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov