NCT03358511已完成不适用
Engineering Gut Microbiome to Target Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Mean number of cytotoxic T lymphocytes (CD8+ cells)
研究概览
简要总结
The purpose of this study is to find out if using probiotics will help the body's immune system react to breast cancer. New studies showed that diverse species of bacteria inside the bowel might help improve immune system, particularly the ability of immune system to recognize cancer. This study will investigate how probiotics will affect the subjects' immune system on breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menopausal females ≥ 18 years of age
- •Histologically confirmed adenocarcinoma of the breast ≥1.0 cm operable stage I-III
- •Must have adequate organ function,
- •Not receive systemic neoadjuvant therapy
- •Be willing to provide tissue, blood, and stool samples for research study.
- •Must not have taken any probiotics in the past 60 days prior to enrollment.
排除标准
- •Patients with autoimmune disease, immune deficiency such as HIV, irritable bowel, known diverticulosis, and other serious GI conditions at treating physician's discretion will be excluded.
结局指标
主要结局
Mean number of cytotoxic T lymphocytes (CD8+ cells)
时间窗: Approximately 4 weeks after baseline
CD8+ T cells (often called cytotoxic T lymphocytes) are very important for immune defence against intracellular pathogens, including viruses and bacteria, and for tumor surveillance.
次要结局
未报告次要终点
研究者
Saranya Chumsri
Associate Professor of Medicine
Mayo Clinic
研究点 (2)
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