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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• ASST GOM Niguarda
  Milan, Lombardy, Italy Recruiting

Study contacts

• Study coordinator: Aglaia Vignoli, Prof, MD
• Email: aglaia.vignoli@ospedaleniguarda.it
• Phone: +390264448408

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.