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Microbiota-gut-brain axis and treatment resistance in epilepsy: a multicentre prospective study protocol (CARE)
Elisa Borghi1,2, Laura Tassi3, Giuseppe d'Orsi4
1Department of Health Sciences, Universita degli Studi di Milano, Milan, Lombardy, Italy.
BMJ Open
|June 3, 2026
Summary
This study explores how gut bacteria and host DNA changes impact epilepsy treatment outcomes. Identifying these microbiota-gut-brain axis biomarkers could predict treatment response in drug-resistant epilepsy patients.
Area of Science:
- Neuroscience
- Microbiology
- Genetics
Background:
- Epilepsy affects one-third of individuals, with many showing resistance to standard treatments like medications, surgery, VNS, and ketogenic diets.
- The gut microbiota-brain axis is increasingly recognized for its potential role in influencing seizure susceptibility and treatment response.
- Understanding these interactions is crucial for developing novel therapeutic strategies for treatment-resistant epilepsy.
Purpose of the Study:
- To investigate the relationship between gut microbial features, host epigenetic signatures, and clinical outcomes in people with epilepsy (PWE).
- To identify microbial and host methylation biomarkers that predict therapeutic response across diverse epilepsy interventions.
- To explore the microbiota-gut-brain axis's role in treatment resistance and prognosis for PWE.
Main Methods:
- A multicentre, prospective, longitudinal study enrolling 3-50 year olds across four intervention cohorts (drug-naïve, surgery, VNS, ketogenic diet).
- Longitudinal collection of clinical data, EEG, MRI, stool, and blood samples over 12 months.
- Gut microbiota analysis via metagenomics (16S rRNA sequencing) and metaproteomics; host DNA methylation profiling using Illumina EPIC arrays.
Main Results:
- Primary endpoints focus on identifying predictive changes in microbial or host methylation associated with seizure reduction.
- Multivariate models and mixed-effect regression will analyze longitudinal data.
- Multi-omics integration will identify molecular signatures and biomarkers for treatment response and prognosis.
Conclusions:
- The study aims to uncover novel biomarkers within the microbiota-gut-brain axis for personalized epilepsy treatment.
- Findings could elucidate mechanisms underlying treatment resistance and improve therapeutic strategies for PWE.
- This research may lead to better prediction of treatment success and patient prognosis.
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