RecruitingNot ApplicableNCT07010445

MiCrobiota-gut-brain Axis in Resistant Epilepsy


Sponsor

Niguarda Hospital

Enrollment

120 participants

Start Date

Aug 16, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 3 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying DRE-KD: ketogenic diet., DRE-VNS: vagal nerve stimulation;, and others for people with drug resistant epilepsy, epilepsy, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNaïve: epilepsy first diagnosis,

no intervention

OTHERDRE-surgery: resective surgery;

resective surgery

DRUGanti-epileptic drugs;

Anti-epileptic drugs,

OTHERDRE-VNS: vagal nerve stimulation;

vagal nerve stimulation

OTHERDRE-KD: ketogenic diet.

ketogenic diet.


Locations(1)

ASST GOM Niguarda

Milan, Lombardy, Italy

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NCT07010445


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