Randomized Controlled Trial Evaluating Trans Auricular Vagal Nerve Stimulation in Patients With Irritable Bowel Syndrome Constipation Subtype
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
This study evaluates the efficacy and safety of transcutaneous auricular vagus nerve stimulation (ta-VNS) in adults with constipation-predominant irritable bowel syndrome (IBS-C). Participants will be randomized to receive either active or sham stimulation using a non-invasive auricular device over a 60-day period.
The primary objectives are to assess changes in symptom severity and quality of life using validated instruments, including the IBS Symptom Severity Scale (IBS-SSS) and the IBS Quality of Life questionnaire (IBS-QOL). Secondary assessments include safety and participant compliance.
This study aims to determine whether ta-VNS is an effective non-invasive therapeutic modality for improving symptoms and quality of life in patients with IBS-C.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred to the WVU Department of Gastroenterology and Hepatology
- •Diagnosis of IBS-C
排除标准
- •Failure of second-line therapy with secretagogues (linaclotide, lubiprostone, plecanatide, or tenapanor)
- •Failure of third-line therapy with tegaserod
- •Known debilitating psychiatric illness
- •Cognitive impairment
- •Pregnancy
- •Prisoners
- •Active substance use disorder
- •Concurrent opioid use
- •History of major gastrointestinal surgery resulting in luminal alteration
- •History of vagotomy
- •Secondary causes of constipation (e.g., opioid use, uncontrolled hypothyroidism, celiac disease)
研究者
Zain Sobani
Assistant Professor
West Virginia University