Influence of Ear Vagus Nerve Stimulator on Patients With IBS - Trial NCT06321237
Access comprehensive clinical trial information for NCT06321237 through Pure Global AI's free database. This phase not specified trial is sponsored by Huaping Xie and is currently Not yet recruiting. The study focuses on Irritable Bowel Syndrome. Target enrollment is 40 participants.
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Study Focus
Sponsor & Location
Huaping Xie
Tongji Hospital
Timeline & Enrollment
N/A
Apr 01, 2024
Jun 09, 2024
Primary Outcome
Changes in irritable bowel symptoms,Changes in the diversity of intestinal flora,Changes in the relative abundance of species of intestinal flora,Changes in the number of intestinal flora
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06321237
Device Trial