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Study on Gut Microbiota and Metabolites in Mediating the Efficacy and Mechanism of Vagus Nerve Stimulation

Study on Gut Microbiota and Metabolites in Mediating the Efficacy and Mechanism of Vagus Nerve Stimulation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500108715
Enrollment
Unknown
Registered
2025-09-03
Start date
2025-09-10
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Epilepsy

Interventions

Sponsors

Sanbo Brain Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with drug-resistant epilepsy, with a disease duration >=2 years, having tried at least two antiepileptic drugs with poor seizure control, and experiencing a seizure frequency >=4 times per month in the past year; 2. No adjustment of antiepileptic medications within 1 month prior to VNS implantation; 3. Normal swallowing function and maintaining a regular diet; 4. Undergoing VNS treatment for the first time; 5. Both patients and their legal guardians fully understand the treatment protocol and voluntarily agree to participate in this study; 6. Patients who have provided informed consent after comprehensive preoperative counseling, voluntarily signed the informed consent form, and have no contraindications for the surgical procedure;

Exclusion criteria

Exclusion criteria: 1. Patients who have undergone previous surgical interventions such as lobectomy, lesionectomy, or deep brain stimulation (DBS) prior to this procedure; 2. Patients with concurrent peptic ulcer disease, diarrhea, or other gastrointestinal disorders (e.g., colitis, Crohn's disease); 3. Patients who have undergone colorectal surgery or received radiotherapy/chemotherapy within the past 3 years; 4. Patients who have received neuromodulation therapies (e.g., transcranial ultrasound) within 3 months prior to enrollment; 5. Use of antibiotics, corticosteroids, or other medications significantly affecting gut microbiota within 4 weeks before sampling; 6. Patients with progressive neurological disorders or other severe systemic diseases; 7. History of substance/alcohol abuse, psychiatric disorders, or current severe depression/anxiety; 8. Female patients during menstrual period (sampling not permitted); 9. Currently participating in other clinical trials; 10. Pregnant, planning pregnancy, or breastfeeding during the study period;

Design outcomes

Primary

MeasureTime frame
McHugh classification;

Secondary

MeasureTime frame
adverse effect;epilepsy frequency;Engel's classification of postoperative outcome;

Countries

China

Contacts

Public ContactYuguang Guan

Sanbo Brain Hospital Capital Medical University

ygguan2000@163.com+86 10 6285 6702

Outcome results

None listed

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