NCT07766733已完成不适用
An Open-Label Pilot Study to Determine Safety and Efficacy of Good Feeling Power® (a Dietary Supplement) in Patients With Either Ulcerative Colitis or Colonic/Ileal Crohn's Disease
Good Feeling Products GmbH1 个研究点 分布在 1 个国家实际入组 36 人开始时间: 2023年11月6日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The effect of Good Feeling Power® on gastrointestinal symptoms, biochemical biomarkers and endoscopic parameters
研究概览
简要总结
This open-label pilot study aims to evaluate the safety and efficacy of the dietary supplement Good Feeling Power® for patients with mild-to-moderate ulcerative colitis and colonic/ileal Crohn's disease.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 支持治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Adults aged 18 - 64
- BMI 18.5 - 32.0 kg/m²
- Mild-to-moderate UC or colonic/ileal CD
- At least one prior episode of active disease
排除标准
- Extensive colonic resection or subtotal or total colectomy
- Currently required or anticipated surgical intervention during the study
- Any prior exposure to natalizumab, efalizumab, or rituximab
- History or evidence of colonic mucosal dysplasia
- Female patients who are lactating or have a positive pregnancy test
- Any unstable or uncontrolled medical disorder that, in the opinion of the investigator, would confound the study results or compromise patient safety.
研究组 & 干预措施
The dietary supplement Good Feeling Power® was administered to all enrolled patients.
Experimental
干预措施: Good Feeling Power® (Dietary Supplement)
结局指标
主要结局
The effect of Good Feeling Power® on gastrointestinal symptoms, biochemical biomarkers and endoscopic parameters
时间窗: From baseline to Day180
The primary outcomes are the changes in gastrointestinal symptoms (Simple Clinical Colitis Activity Index for ulcerative colitis (UC) patients and the Harvey-Bradshaw Index for Crohn's disease (CD) patients), biochemical biomarkers in feces (calprotectin, immunoglobulin A, hemoglobin), and endoscopic parameters (Mayo Endoscopic Score).
次要结局
- Safety of Good Feeling Power® for patients with mild-to-moderate UC or CD(From baseline to Day180)
研究者
研究点 (1)
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标识符
- NCT 编号
- NCT07766733
- 其他研究编号
- GFP_IDA14-1
日期
- 首次提交
- (上个月)
- 首次发布
- (上个月)
- 主要完成日期
- (去年)
- 研究完成日期
- (去年)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
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