Health TrialsbyHealthPanel

MiCrobiota-gut-brain Axis in Resistant Epilepsy

ConditionsGut MicrobiotaEpilepsyDrug-Resistant Epilepsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-50
SponsorNiguarda Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

diagnosis of organic gastrointestinal disorders (e.g. chronic inflammatory bowel disease);

special diets;

use of antibiotics, corticoids or probiotics in the previous month.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Naïve: epilepsy first diagnosis,

    Other intervention

    no intervention

  • DRE-surgery: resective surgery;

    Other intervention

    resective surgery

  • anti-epileptic drugs;

    Drug

    Anti-epileptic drugs,

  • DRE-VNS: vagal nerve stimulation;

    Other intervention

    vagal nerve stimulation

  • DRE-KD: ketogenic diet.

    Other intervention

    ketogenic diet.

Treatment groups

120 Participants
are divided into 5 treatment groups
Group A: NaïveOther 1 intervention
Group B: DRE-surgeryOther 1 intervention
Group C: DRE-VNSOther 1 intervention
Group D: DRE-KDOther 1 intervention
Group E: anti-epileptic drugs;Other 1 intervention

Trial outcomes

Primary outcomes

1

Gut Microbiota Changes

Gut microbiota composition and changes (at different levels: e.g. phyla, families, species) in groups of responders (e.g. seizure reduction \>50%,\>75% or 100% from baseline in monthly seizure counts) after 1,6, and 12 months of ASMs therapy or surgery, VNS and KD whenDRE;

Time frame
1 - 6 - 12 months
2

Gut Microbiota Biomarkers

Identification of specific biomarkers (e.g. changes in gut microbiota species) in groups of responders, that could help clinicians to choose the intervention with the most likelihood of improving patients quality if life (performance assessed when Area Under the Curve AUC \> 0.8).

Time frame
1,6, and 12 months

Secondary outcomes

1

Quality of Life

PedsQL or QOLIE-31 questionnaires

Time frame
6 - 12 months
2

Gastrointestinal health

Significant changes in gastrointestinal health questionnaire, such as a decrease in GISI score (max score = 17) by at least 2 points;

Time frame
6 - 12 months
3

Methylation Level

Correlation between the variation of methylation level at each CpG and gut microbial changes enriched in responders (\>50% seizure reduction) at 6 and 12 months (GM mediated mDNA -Mitochondrial DNA profiles of responding patients surviving multiple testing correction; False Discovery Rate FDR \< 0.1).

Time frame
6 - 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Niguarda Hospital

Lead sponsor

Source ClinicalTrials.gov
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