Influence of Ear Vagus Nerve Stimulator on Patients With IBS

Summary

Irritable bowel syndrome (IBS) is a very common functional digestive disorder characterized by chronic abdominal pain and altered bowel habits in the absence of biological or structural abnormalities. In the field of IBS, effective drug treatments are very limited, and patients are urgently looking for alternatives, including probiotics, hypnotherapy, osteopathy, dietary changes, and fecal microbiota transplants. In recent years, with the continuous elucidation of vagus nerve mechanisms, IBS patients are increasingly interested in bioelectrical regulation, and these patients are often skeptical of traditional drug treatment and believe that drugs are prone to side effects. For several reasons, vagus nerve stimulation (VNS) may be a promising option for improving IBS symptoms. In this experiment, the portable ear nail stimulator produced by Ruishen Medical can accurately stimulate the ear nail, transdermal stimulation of the ear vagus nerve, and give full play to its therapeutic effect. Therefore, the purpose of this clinical trial is to use ear nail stimulator in patients with IBS to explore whether it has therapeutic effects on patients with IBS. To explore the influence of tVNS therapy on irritable bowel syndrome compared with drug therapy, it is hoped that the use of TVNS therapy can reduce the use of related drugs, or even replace drugs. This study intends to recruit a group of patients with irritable bowel syndrome to use the portable ear nail stimulator, (1) to observe whether the symptoms of irritable bowel syndrome patients are improved; (2) To analyze the changes of intestinal microbes in patients with IBS; (3) Verify whether the level of intestinal inflammation is reduced and discover metabolic markers in the intestine.

Conditions

• Irritable Bowel Syndrome

Interventions

DEVICE

Vagus nerve stimulation for 8 weeks

The vagus nerve at the position of the ear nail was stimulated by an ear nail stimulator with pulse width of 200μs and frequency of 30Hz in patients with IBS for 8 weeks

DEVICE

Vagus nerve stimulation for the first 4 weeks

The vagus nerve at the position of the ear nail was stimulated by an ear nail stimulator with pulse width of 200μs and frequency of 30Hz in patients with IBS for the first 4 weeks

DEVICE

Vagus nerve stimulation for the last 4 weeks

The vagus nerve at the position of the ear nail was stimulated by an ear nail stimulator with pulse width of 200μs and frequency of 30Hz in patients with IBS for the last 4 weeks

DEVICE

Pseudostimulus

The patient is given some electrical stimulation but not vagus nerve stimulation

Sponsors & Collaborators

• Huaping Xie

  lead OTHER

Principal Investigators

• ping h Xie · Tongji Medical College of Huazhong University of Science and Technology

• qiang Ding · Tongji Medical College of Huazhong University of Science and Technology

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-01

Primary Completion

2024-05-26

Completion

2024-06-09