NCT07010445 MiCrobiota-gut-brain Axis in Resistant Epilepsy
| NCT ID | NCT07010445 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Niguarda Hospital |
| Condition | Gut Microbiota |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-08-16 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-08-16 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07010445 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 50 Years, studying Gut Microbiota. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07010445 currently recruiting?
Yes, NCT07010445 is actively recruiting participants. Contact the research team at aglaia.vignoli@ospedaleniguarda.it for enrollment information.
Where is the NCT07010445 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07010445 clinical trial?
NCT07010445 is sponsored by Niguarda Hospital. The trial plans to enroll 120 participants.