Gut-brain-axis alterations after vagus nerve stimulation in refractory epilepsy

Gut-brain-axis alterations after vagus nerve stimulation in refractory epilepsy - E-GUT-VNS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51448

Enrollment

Registered

2022-12-29

Start date

2023-09-18

Completion date

Unknown

Last updated

2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory epilepsy

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Drug-resistent epilepsy (DRE) patients that are accepted for VNS therapy - Adult (18 years or older) and is capable of providing informed consent

Exclusion criteria

Exclusion criteria: - Pregnancy or breastfeeding (assessed through anamnesis) - Mental retardation (IQ score

Design outcomes

Primary

Measure	Time frame
Intestinal permeability (LPS binding protein, main study parameter)	—

Secondary

Measure	Time frame
Intestinal microbiome, intestinal inflammation (calprotectin), immunological parameters (general immunological function (IL-1-beta, IL-6, IL-8, IL-10, IFN-gamma, TNF-alpha, IL-1RA, CRP); blood-brain-barrier (GFAP, S100b); neurotrophins (neurotrophin-3, BDNF, neurofilament H, neurofilament L); and metabolic factors (IGF-1, IGF-1R, leptin, insulin)), volatile organic compounds (VOC) before and after implantation	—

Measure

Time frame

Intestinal microbiome, intestinal inflammation (calprotectin), immunological parameters (general immunological function (IL-1-beta, IL-6, IL-8, IL-10, IFN-gamma, TNF-alpha, IL-1RA, CRP); blood-brain-barrier (GFAP, S100b); neurotrophins (neurotrophin-3, BDNF, neurofilament H, neurofilament L); and metabolic factors (IGF-1, IGF-1R, leptin, insulin)), volatile organic compounds (VOC) before and after implantation

—

Countries

Netherlands

Outcome results