NCT03072641已完成不适用
Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer
Vastra Gotaland Region0 个研究点目标入组 20 人开始时间: 2010年6月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Changes in microbiota composition after probiotics use
研究概览
简要总结
The purpose of the study is to determine if probiotic bacteria have a beneficial effect on the colon cancer-associated microbiota and epigenetic alterations in colon cancer. Dietary supplementation consists of two ProBion Clinica tablets, yielding a daily dose of 1.4 x 10 ˄ 10 Bifidobacterium lactis Bl-04 (ATCC SD5219), 7x10 ˄ 9 Lactobacillus acidophilus NCFM (ATCC 700396), and 0.63 g inulin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •At least one malignant tumor in the colon
排除标准
- •Study subjects with adenomas, or
- •who received recent antibiotic therapy or
- •consumed probiotics regularly were excluded.
结局指标
主要结局
Changes in microbiota composition after probiotics use
时间窗: 8-78 days depending on time elapsed from inclusion to surgical removal of tumor
The microbiota composition is analysed at baseline and after probiotics use in tissue and faeces samples
次要结局
- Epigenetic changes after probiotics use(8-78 days depending on time elapsed from inclusion to surgical removal of tumor)
研究者
Yvonne Wettergren
Associate professor
Vastra Gotaland Region
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