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MiCrobiota-gut-brain Axis in Resistant Epilepsy

NCT07010445 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-09

No results posted yet for this 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.

Conditions

  • Gut Microbiota
  • Epilepsy
  • Drug-Resistant Epilepsy

Interventions

OTHER

Naïve: epilepsy first diagnosis,

no intervention

OTHER

DRE-surgery: resective surgery;

resective surgery

DRUG

anti-epileptic drugs;

Anti-epileptic drugs,

OTHER

DRE-VNS: vagal nerve stimulation;

vagal nerve stimulation

OTHER

DRE-KD: ketogenic diet.

ketogenic diet.

Sponsors & Collaborators

  • Niguarda Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-16
Primary Completion
2026-08-31
Completion
2027-02-28

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07010445 on ClinicalTrials.gov