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临床试验/NCT04138979
NCT04138979Unknown不适用

Intestinal Microbiota of Breast Cancer Patients Undergoing Chemotherapy

First Affiliated Hospital of Harbin Medical University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年9月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Transcriptional changes in gut microbiota

研究概览

简要总结

To date, few studies have addressed the link between gut microbiota and breast cancer chemotherapy, and previous studies have only provided a link between the gut and breast cancer.

详细描述

To date, few studies have addressed the link between gut microbiota and breast cancer chemotherapy, and previous studies have only provided a link between the gut and breast cancer.At present, studies on the interaction mechanism between intestinal flora and breast cancer mainly focus on two aspects: first, intestinal flora affects the occurrence and progress of breast cancer by affecting estrogen metabolism;Second, intestinal flora can influence the occurrence and treatment of breast cancer by affecting the regulation of the immune system.However, the specific types (or groups) of bacteria that promote the occurrence, development and mechanism of breast cancer still need to be further studied.In addition, since most of the current clinical studies on microorganisms and breast cancer are small sample studies, the accuracy of their conclusions remains to be studied.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Aged 18 to 65 years
  • First use of chemotherapy after breast cancer

排除标准

  • Pregnancy
  • Lactation
  • Cigarette smoking
  • Alcohol addiction
  • Hypertension
  • Diabetes mellitus
  • Lipid dysregulation
  • BMI > 27
  • Recent (< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or Chinese herbal medicine
  • History of disease with an autoimmune component, such as MS, rheumatoid arthritis, IBS, or IBD
  • History of malignancy or any gastrointestinal tract surgery

研究组 & 干预措施

Disease group

First chemotherapy for breast cancer

干预措施: cyclophosphamide (Drug)

结局指标

主要结局

Transcriptional changes in gut microbiota

时间窗: baseline,1 day,7 day,14 days,22 days,29 days,36 days,44days,51days,58days,66days,73days,80days

The microbiota measured by 16S rRNA gene

次要结局

未报告次要终点

研究者

发起方
First Affiliated Hospital of Harbin Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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