Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Patients With Ulcerative Proctitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Adverse events
研究概览
简要总结
Low Level Light therapy (LLLT) has been used for tissue healing in many mucosal diseases that involve wounds, ulcers and inflammation, oral chemotherapy-induced mucositis in particular. Likewise IBD is characterized by chronic tissue inflammation, tissue damage and ulcerations in various extents. Therefore we hypothesize that LLLT might be effective in treating IBD and the Photopill capsule was developed for this purpose.
An open-label, interventional, clinical trial was designed for assessment of the safety and feasibilty of the Photopill capsule treatment in patients with mild to moderate Ulcerative Proctitis.
Primary endpoints being: safety reflected by the number and severity of adverse events and mucosal appearance at sigmoidoscopies day 14, day 28, day 42 compared to baseline condition.
Furthermore clinical and biochemical parameters are monitored during the study.
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
- •Diagnosed with Ulcerative Proctitis (Mayo grade 1/2)
排除标准
- •Symptomatic hemorrhoids
- •Pregnant or lactating females
- •Patients that have used any experimental treatment within 8 weeks prior to Day 0
- •Patient that have used any biologics therapies or immunomodulation agents and/or steroids 4 weeks prior to Day 0
- •Rectal therapy 2 weeks prior to Day 0
结局指标
主要结局
Adverse events
时间窗: day 0-42
Any adverse events reported by subjects
次要结局
- Inflammatory markers(day 0,14,28,42)
- Clinical Questionnaires(day 0,14,28,42)
- Mucosal appearance at sigmoidoscopy(week 0,14,28.42)
研究者
Hanke Brandse
MD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)