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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ASST GOM Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
Related publications
- Microbiota-gut-brain axis and treatment resistance in epilepsy: a multicentre prospective study protocol (CARE).BMJ Open · 2026 · PMID 42236101
This page is information, not medical advice. Discuss any trial with your doctor.