Gut–brain microbiota link in new‑onset and drug‑resistant epilepsy

MiCrobiota-gut-brain Axis in Resistant Epilepsy

This project will see if gut bacteria and their chemical products are linked to how well people with new‑onset or drug‑resistant epilepsy do after surgery, vagus‑nerve stimulation, or a ketogenic diet.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 3 Years to 50 Years
• Sex: All
• Sponsor: Niguarda Hospital (other)
• Locations: 1 site (Milan, Lombardy)
• Trial ID: NCT07010445 on ClinicalTrials.gov

What this trial studies

This longitudinal study will enroll people with first‑time seizures and patients with drug‑resistant epilepsy who are undergoing resective surgery, vagus‑nerve stimulation (VNS), or ketogenic diet (KD), and will follow them for about 12 months with visits over ~15 months from screening to last follow‑up. Investigators will collect stool for gut microbiota and metabolic profiling alongside detailed clinical, biochemical, neurophysiological, neuroradiological, and genetic data at baseline (before antiseizure medications when possible) and multiple post‑treatment time points. The target enrollment is at least 50 subjects at seizure onset, 50 DRE undergoing surgery, 10 DRE receiving VNS, and 10 DRE on KD. Data analysis aims to identify microbial biomarkers that correlate with clinical outcomes after these different therapeutic procedures.

Who should consider this trial

Good fit: Ideal candidates are people aged 3–50 with a new diagnosis of epilepsy or drug‑resistant epilepsy who are willing to provide consent (or have a consenting caregiver) and can attend follow‑up visits, and who have not used antibiotics, corticosteroids, or probiotics in the prior month and do not follow special diets.

Not a fit: Patients with chronic organic gastrointestinal diseases, those on special diets, or those who recently used antibiotics, corticosteroids, or probiotics (within one month) — as well as people outside the 3–50 age range — are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could identify gut microbiome biomarkers that help personalize treatments and improve seizure outcomes for people with epilepsy.

How similar studies have performed: Animal and human studies have linked the gut microbiome to epilepsy and shown microbiome changes with ketogenic diet, but using microbiome profiles to predict outcomes after surgery or VNS remains largely untested.

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.

Where this trial is running

Milan, Lombardy

• ASST GOM Niguarda — Milan, Lombardy, Italy (RECRUITING)

Study contacts

• Study coordinator: Aglaia Vignoli, Prof, MD

Conditions: Gut Microbiota, Epilepsy, Drug-Resistant Epilepsy