NCT07114159招募中不适用
An Open-label Clinical Trial to Evaluate the Long-term Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis
Xijing Hospital1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年8月2日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change from baseline in the Mayo score
研究概览
简要总结
Although the incidence of inflammatory bowel disease is stable in North American and European countries, the incidence of inflammatory bowel disease is increasing in newly industrialized countries, especially in China. The treatment drugs for ulcerative colitis include 5-aminosalicylic acid (5-ASA), glucocorticoids, immunosuppressants, and biological agents. The aim of this clinical trial is to evaluate the long-term safety and efficacy of sacral nerve stimulation in patients with ulcerative colitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-65 years
- •ulcerative colitis diagnosed for at least 3 mouths.
- •Mayo score 6-12, Mayo endoscopic score 2-3 points
- •resistant to medical treatment
排除标准
- •Treatment-naive ulcerative colitis (no previous treatment)
- •Acute severe ulcerative colitis
- •Currently taking any biologicals
- •Previous surgical treatment or severe colitis at imminent risk of surgery
- •infective colitis
- •Other systemic diseases
- •Pregnancy and lactation
研究组 & 干预措施
Sacral nerve stimulation
Experimental
干预措施: Sacral nerve stimulation (Device)
结局指标
主要结局
Change from baseline in the Mayo score
时间窗: From baseline to 8 years
The range of Mayo score is 0-12, and higher scores mean worse outcome
次要结局
- Clinical remission(From baseline to 8 years)
- Clinical response(From baseline to 8 years)
- Change from baseline in the Truelove and Witts Severity Index(From baseline to 8 years)
- Endoscopic remission(From baseline to 8 years)
- Fecal calprotectin levels(From baseline to 8 years)
- erythrocyte sedimentation rate levels(From baseline to 8 years)
- C reactive protein levels(From baseline to 8 years)
- Inflammatory Bowel Disease Questionnaire Score(From baseline to 8 years)
- Hospital Anxiety and Depression scale score(From baseline to 8 years)
- Gut microbiota profile(From baseline to 8 years)
- The Pittsburgh Sleep Quality Index(From baseline to 8 years)
研究者
研究点 (1)
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