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临床试验/NCT03072641
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

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

发起方
Vastra Gotaland Region
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Yvonne Wettergren

Associate professor

Vastra Gotaland Region

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