NCT04552405已完成不适用
Preventive Anti-inflammatory Diet to Reduce Gastro-intestinal Inflammation in FAP Patients: a Prospective Pilot Study
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2017年9月12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
- 35
- 试验地点
- 1
- 主要终点
- Evaluate changes in calprotectin levels
研究概览
简要总结
Preventive anti-inflammatory diet to reduce gastro-intestinal inflammation in FAP patients: a prospective pilot study
详细描述
a prospective pilot 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
- Prevention
- 盲法
- None
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
- •FAP patients carrying mutations in APC gene, submitted to prophylactic total colectomy/IRA (with rectum preservation) and that participate to the regular endoscopic surveillance program at IRCCS-INT.
排除标准
- •FAP patients taking NSAIDs and/or Omega 3
- •Patients who carried MUTYH germline mutations or had no APC mutation found.
研究组 & 干预措施
FAP patients
Other
FAP patients who underwent prophylactic total colectomy
干预措施: Anti-inflammatory Diet (Dietary Supplement)
结局指标
主要结局
Evaluate changes in calprotectin levels
时间窗: baseline, at 3 months and 6 months post anti-inflammatory diet consumption.
Change from baseline in calprotectin levels at 3 months and 6 months post anti-inflammatory diet consumption.
次要结局
- Evaluate changes in circulatory inflammatory markers(baseline, at 3 months and 6 months post anti-inflammatory diet consumption.)
- Evaluate the effect on polyps growth(baseline and 6 months post anti-inflammatory diet consumption)
- Evaluate changes in the number of diarrheal discharges(baseline, at 3 months and 6 months post anti-inflammatory diet consumption)
- Evaluate changes in the immune cell profile(baseline, at 3 months and 6 months post anti-inflammatory diet consumption)
- Evaluate changes in stool inflammatory markers(baseline, at 3 months and 6 months post anti-inflammatory diet consumption)
研究者
研究点 (1)
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