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Observational clinical study on intestinal microbial changes after the implantation of a vagal nerve stimulator in patients with drug-refractory epilepsy

Intestinal microbial changes after the implantation of a vagal nerve stimulator in patients with drug-refractory epilepsy

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200055717
Enrollment
Unknown
Registered
2022-01-16
Start date
2022-03-01
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

epilepsy

Interventions

1 (Vagus nerve stimulation):None
2:None

Sponsors

Zhujiang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. No treatable epilepsy cause was found, or treatment failure for the cause; 2. Epileptic patients who meet the diagnostic criteria of the International Anti-epilepsy Alliance; 3. Conscious and can cooperate with the extraction specimen; 4. All subjects volunteered to participate in the experiment.

Exclusion criteria

Exclusion criteria: 1. VNS placement-related contraindications (history of bilateral injuries or cuts; local infection at implantation site; specific rejection, intolerance to foreign body implantation, poor general surgery; microwave or short-wave hyperthermia, severe heart block, severe digestive disorders, rapidly progressive life-threatening genetic metabolic disease and obstructive sleep apnea. The presence of magnetic control devices such as adjustable pressure shunt tubes in the body needs to pay attention to the possible interaction with VNS devices.); 2. Family history of drug-refractory epilepsy, persistent infectious disease, inflammatory bowel disease, irritable bowel syndrome, autoimmune disease, liver disease, kidney disease, cancer and diarrhea, and the use of antibiotics or probiotics within 2 months prior to sample collection.

Design outcomes

Primary

MeasureTime frame
Metagenomic sequencing;electroencephalogram (EEG);

Countries

China

Contacts

Public ContactGuo Yanwu

Zhujiang Hospital of Southern Medical University

dguoyanwu@163.com+86 139 2603 5600

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026