NCT07010445

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Aug 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Aug 2024Feb 2027

Study Start

First participant enrolled

August 16, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 8, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

April 7, 2025

Last Update Submit

April 6, 2026

Conditions

Gut MicrobiotaEpilepsyDrug-Resistant Epilepsy

Outcome Measures

Primary Outcomes (2)

  • 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;

    1 - 6 - 12 months

  • 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).

    1,6, and 12 months

Secondary Outcomes (3)

  • Quality of Life

    6 - 12 months

  • Gastrointestinal health

    6 - 12 months

  • Methylation Level

    6 - 12 months

Study Arms (5)

Naïve

OTHER

Subjects at the seizure onset (Naïve)

Other: Naïve: epilepsy first diagnosis,

DRE-surgery

OTHER

DRE undergoing resective surgery (DRE-surgery)

Other: DRE-surgery: resective surgery;

DRE-VNS

OTHER

DRE undergoing vagal nerve stimulation (DRE-VNS)

Other: DRE-VNS: vagal nerve stimulation;

DRE-KD

OTHER

DRE on diet therapy (Ketogenic diet).

Other: DRE-KD: ketogenic diet.

anti-epileptic drugs;

OTHER

anti-epileptic drugs;

Drug: anti-epileptic drugs;

Interventions

Naïve: epilepsy first diagnosis,OTHER

no intervention

Naïve
DRE-surgery: resective surgery;OTHER

resective surgery

DRE-surgery
anti-epileptic drugs;DRUG

Anti-epileptic drugs,

anti-epileptic drugs;
DRE-VNS: vagal nerve stimulation;OTHER

vagal nerve stimulation

DRE-VNS
DRE-KD: ketogenic diet.OTHER

ketogenic diet.

DRE-KD

Eligibility Criteria

Age3 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years old;
  • diagnosis of epilepsy at onset or DRE;
  • ensured participation of the patient or a caregiver;
  • willingness to sign the informed consent.

You may not qualify if:

  • diagnosis of organic gastrointestinal disorders (e.g. chronic inflammatory bowel disease);
  • special diets;
  • use of antibiotics, corticoids or probiotics in the previous month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASST GOM Niguarda

Milan, Lombardy, 20162, Italy

RECRUITING

MeSH Terms

Conditions

EpilepsyDrug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Aglaia Vignoli, Prof, MD

CONTACT

+390264448408aglaia.vignoli@ospedaleniguarda.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2025

First Posted

June 8, 2025

Study Start

August 16, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)