"The Impact of Enteral Immunonutrition on Gut Microbiota, Intestinal Permeability, and Inflammation of Intestines in Colorectal Cancer as Well as Gastric Cancer Patients - a Randomized Trials"
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- The impact of immunonutrition on gut microbiota in gastric and colorectal cancer patients.
研究概览
简要总结
Enteral immunomodulating nutrition modifies the gastrointestinal microbiota as well as improves the intestinal barrier integrity in patients with gastric and colorectal cancer in the perioperative period. As a consequence, it contributes to the reduction of the incidence of postoperative complications and diarrhea, which is a side effect of anti-cancer treatment often used preoperatively in this group of cancers.
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
- Single (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
- •age >18 y.o.
- •patients with gastric or colorectal cancer
- •patients treated in Department of Surgical Oncology, Medical University of Gdańsk
- •patients' agreement to take part in this study
排除标准
- •age <18 y.o.
- •other types of cancer than gastric/colorectal cancer
- •the presence of inflammatory bowel disease
- •pregnancy
结局指标
主要结局
The impact of immunonutrition on gut microbiota in gastric and colorectal cancer patients.
时间窗: at baseline and after 7 and 10 days
The composition of gut microbiota (bacteria and fungi) will be assessed from stools. The amounts of bacteria/fungi will be presented using bioinformatics tools and there is no precisely described units (only the total number).
次要结局
- The impact of immunonutrition on intestinal permeability in gastric and colorectal cancer patients.(at baseline and after 7 and 10 days)
- The impact of immunonutrition on intestines in gastric and colorectal cancer patients.(at baseline and after 7 and 10 days)
研究者
Karolina Kaźmierczak-Siedlecka
Karolina Kaźmierczak-Siedlecka (nutritionist, PhD), senior assistant, Department of Surgical Oncology
Medical University of Gdansk