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CARENCT07010445

MiCrobiota-gut-brain Axis in Resistant Epilepsy

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved at least 6 months later.

See at-risk trials from Niguarda Hospital

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 2026 to Feb 28, 2027 Show 5 more changesShow less
    • Eligibility criteria expanded, about 7 words
    • Study completion date: Feb 2027 to Feb 28, 2027
    • Secondary endpoints: details revised at 1 of 3 entries
    • Study description shortened, about 6 words
    • Publications: details revised at 1 of 1 entry
  2. Interventions: Naïve: epilepsy first diagnosis, anti-epileptic drugs; DRE-surgery: resective surgery; DRE-VNS: vagal nerve stimulation; DRE-KD: ketogenic… to DRE-KD: ketogenic diet. (Other), DRE-VNS: vagal nerve stimulation; (Other), DRE-surgery: resective surgery; (Other), Naïve: epilepsy first…
    • Secondary endpoints: details revised at 1 of 3 entries
    • Study arms: 4 to 5
    • Study description shortened, about 1 word
    v2
  3. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Gut Microbiota Changes
Timeframe: 1 - 6 - 12 months
Gut Microbiota Biomarkers
Timeframe: 1,6, and 12 months

Secondary (3)

Quality of Life
Gastrointestinal health
Methylation Level

Arms and interventions

NaïveOther

Subjects at the seizure onset (Naïve)

DRE-surgeryOther

DRE undergoing resective surgery (DRE-surgery)

DRE-VNSOther

DRE undergoing vagal nerve stimulation (DRE-VNS)

DRE-KDOther

DRE on diet therapy (Ketogenic diet).

anti-epileptic drugs;Other

anti-epileptic drugs;

Other: Naïve: epilepsy first diagnosis,, DRE-surgery: resective surgery;, DRE-VNS: vagal nerve stimulation;, DRE-KD: ketogenic diet.

Drugs: anti-epileptic drugs;

Sites

1 site in 1 country

  • ASST GOM NiguardaMilan, Lombardy, Italy