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NCT07010445Recruiting

MiCrobiota-gut-brain Axis in Resistant Epilepsy

Source: ClinicalTrials.gov · Last updated 9 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
120 (estimated)
First submitted
7 Apr 2025
Start date
16 Aug 2024
Primary completion date
31 Aug 2026
Lead sponsor
Niguarda Hospital
Diseases
Epilepsy
NCT number
NCT07010445

What you commit to

  • Study type: Interventional
  • Planned participants: 120
  • From 16 Aug 2024 to the primary completion date, 31 Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • use of antibiotics, corticoids or probiotics in the previous month.

Other illness

  • diagnosis of organic gastrointestinal disorders (e.g. chronic inflammatory bowel disease);

Other

  • special diets;

Who the study is looking for

  • 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.

Age in the registry: 3 years to 50 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
ASST GOM Niguarda
Coordinator of this site? Confirm its status
MilanItalyRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.