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MiCrobiota-gut-brain Axis in Resistant Epilepsy

RecruitingNAAges 3 Years - 50 YearsAllNiguarda Hospital
NCT07010445 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 g

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📋 Eligibility rules (as published)
Inclusion criteria: * 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. Exclusion criteria: * diagnosis of organic gastrointestinal disorders (e.g. chronic inflammatory bowel disease); * special diets; * use of antibiotics, corticoids or probiotics in the previous month.
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What it tests

  • Naïve: epilepsy first diagnosis,
  • DRE-surgery: resective surgery;
  • anti-epileptic drugs;
  • DRE-VNS: vagal nerve stimulation;
  • DRE-KD: ketogenic diet.
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Where

1 site
ASST GOM Niguarda
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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