Intestinal Microflora in Lung Cancer After Chemotherapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Composition of Microorganisms in stool after probiotic intervention
研究概览
简要总结
Probiotics modulate the gut microflora and immune status in lung cancer who need chemotherapy.
详细描述
Chemotherapy destroys the intestinal mucosal barrier, affects intestinal flora, causing bacterial translocation, infection and other complications. Probiotics may restore the intestinal immunity, mucosal barrier and nutrient absorption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for chemotherapy of lung cancer
排除标准
- •Antibiotic, probiotic or prebiotic usage within 1month
- •Other malignancy
- •History of abdominal surgery
- •Pregnant or breast-feeding (for females)
- •Impaired liver or renal function
- •Diabetes, thyroid disorder, coagulopathy or bleeding disorders, mental disorder
研究组 & 干预措施
Probiotic
Microbial composition using probiotics,3 capsules/times,3 times/day for 3 to 4 weeks
干预措施: Probiotics (Drug)
Placebo
Microbiota modulation using probiotics,3 capsules/times,3 times/day for 3 to 4 weeks
干预措施: placebo (Drug)
结局指标
主要结局
Composition of Microorganisms in stool after probiotic intervention
时间窗: 2 months
Primary coordination of fecal samples' 16s(%) rDNA will be compared between two groups using Braycurtis distance based Primary coordination analysis(PCoA)
次要结局
- Frequency and severity of Adverse effects during Chemotherapy(2 months)
- The change of immunity and nutrition index(2 months)
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University