Effects of Gut Microflora on the Immune and Nutritional Status of CRC Patients After Chemotherapy
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 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 CRC,which can reduce the side effects of chemotherapy such as diarrhea,infection,neutropenia etc.
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.The adverse effects of chemotherapy and the malnutrition status may be relieved via probiotic administration.
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 after radical resection of colorectal cancer
排除标准
- •Palliative resection of colorectal cancer
- •Antibiotic,probiotic or prebiotic usage within 1months
- •Other malignancy
- •History of other abdominal surgery
- •Coagulopathy or bleeding disorders
- •Pregnant or breast-feeding(for females)
- •Impaired liver or renal function
研究组 & 干预措施
Probiotic
Microbial composition using Probiotic，3 capsules / times, 2 times / day for 4 weeks
干预措施: Probiotic (Drug)
placebo
Microbiota modulation using placebo，3 capsules / times, 2 times / day for 4 weeks
干预措施: placebo（for probiotic） (Drug)
结局指标
主要结局
Composition of Microorganisms in stool after probiotic intervention
时间窗: 5 months
Primary coordination of fecal samples' 16s rDNA (ribosomal DNA) will be compared between two Groups using Braycurtis distance based Primary coordination analysis (PCoA).
Short-chain fatty acids in feces of patients after chemotherapy
时间窗: 5 months
The total concentration of Short-chain fatty acids in the in feces of patients after chemotherapy.
Frequency and severity of Adverse effects during Chemotherapy
时间窗: 5 months
Adverse effects includes vomiting, nausea, diarrhea and abdominal pain.
次要结局
- The observed changes in immune status after chemotherapy(5 month)
- The observed changes in nutritional status after chemotherapy(5 months)
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University