Actively Recruiting
MiCrobiota-gut-brain Axis in Resistant Epilepsy
Led by Niguarda Hospital · Updated on 2026-04-09
120
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
MiCrobiota-gut-brain Axis in Resistant Epilepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 3 and 50 years
- Diagnosis of epilepsy at onset or drug-resistant epilepsy
- Ability to participate with or without a caregiver
- Willingness to sign the informed consent
You will not qualify if you...
- Diagnosis of organic gastrointestinal disorders such as chronic inflammatory bowel disease
- Following special diets
- Use of antibiotics, corticoids, or probiotics within the previous month
AI-Screening
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Trial Site Locations
Total: 1 location
1
ASST GOM Niguarda
Milan, Lombardy, Italy, 20162
Actively Recruiting
Research Team
A
Aglaia Vignoli, Prof, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
5
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