A Modified Microbiota-Accessible Carbohydrates (MAC) Diet and Change of Gut Microbiota in Patients With Colorectal Cancer After Surgery: A Prospective, Open-label, Cross-over, Single Center Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The change of gut microbiota diversity
研究概览
简要总结
To explore the changes in the composition and diversity of intestinal microbiota during 3-weeks of modified MAC diet and conventional diet in stage I or low-risk stage II colorectal cancer (CRC) patients after surgery. Additionally, the investigator analyze the association of gut microbiota and stool formation pattern or quality of life according to dietary pattern. Therefore, the investigator identify the beneficial or harmful microbiota composition and diversity adapting modified MAC diet that related to cancer recurrence, which provide supporting evidence for future prospective trial.
详细描述
Colorectal cancer is the third most common cancer worldwide and a life-threatening disease that kills more than 500,000 people every year. It is known that, environmental factors such as diet and lifestyle play an important role in the development of colorectal cancer due to large differences in the incidence rate by region in addition to the genetic background associated with colorectal cancer. The physical activity, whole grains, dietary fiber, dairy products, and calcium supplement intake are factors that inhibit colorectal cancer, but red meat, processed meat, alcohol, and obesity act as risk factors inducing colorectal cancer. Therefore, it can be said that efforts to prevent cancer are important compared to other cancers.
A growing interest in the interaction of the gut microbiome with its host and its important role in health and disease is revealing that the interaction of the gut microbiome with humans plays an important role in the development of degenerative diseases, cancers and inflammatory diseases. According to recent studies, the risk of colorectal cancer is increased by the presence of specific gut microbiota, dysbiosis, and the interaction between diet and gut microbes. In other words, changes in diet affect the formation of the intestinal microbiota, and conversely, microorganisms mediate the generation of dietary factors that cause colorectal cancer.
In addition, microorganisms such as Fusobacterium nucleatum regulate autophagy and play a role in making it resistant to chemotherapy after colon cancer surgery, or whole grains in colorectal cancer patients with Fusobacterium nucleatum in tumor tissue. However, a cohort study has also reported that consuming a diet rich in dietary fiber helps to lower the incidence of colorectal cancer.
Diet and nutrients play a decisive role in the composition of the intestinal microflora involved in the regulation of inflammation and immune responses.
Microbiota-Accessible Carbohydrates (MAC) refer to carbohydrates that the human intestine cannot digest, but that can be digested by intestinal microbes. It is not decomposed and not absorbed in the stomach or small intestine, and then broken down in the large intestine and then digested and metabolized by the intestinal microflora. During that process, short chain fatty acid (SCFA) is produced, which is known to increase beneficial intestinal bacteria and decrease inflammation around intestinal cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed colorectal adenocarcinoma patients after curative surgery without post-operative chemotherapy (stage I and low-risk stage II)
- •Male of female participants over the age of 19
- •Eastern Cooperative Oncology Group (ECOG) performance score 0-2
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol
- •Adequate hematologic and end-organ function
排除标准
- •Patients with temporary/permanent stoma after surgery
- •Diagnosed with locally advanced stage (more than high-risk stage II) colorectal cancer which require postoperative chemotherapy after surgery
- •Diagnosed with metastatic stage IV colorectal cancer after surgery
- •Uncontrolled diabetes (glycated hemoglobin A1c (HbA1c) > 8.0 g/dl)
- •Active infection requiring antibiotics, antifungal or antiviral agents or received a course of antibiotics within 4 weeks prior to study treatments
- •Known history of food allergy
- •Known history of uncontrolled intercurrent illness including but not limited to: Infection/inflammation; severe liver dysfunction; bilateral interstitial lung disease; uncontrolled kidney disease; clinically significant (active) cardiovascular and pulmonary disease; hemorrhagic disease; inflammatory bowel disease, intestinal obstruction; Inability to swallow food; social and psychological problems etc.)
- •Other medical and psychiatric conditions that would prohibit the understanding or rendering of informed consent which affect study compliance
结局指标
主要结局
The change of gut microbiota diversity
时间窗: Stool sample collection for baseline, after the first 3-week diet, and then after second 3-week diet
a-diversity for interpersonal change and b-diversity for groups using 16s rRNA sequencing
次要结局
- The change of stool formation pattern(Up to 6 week (during study period))
- The change of gut microbiota metabolite(Stool sample collection for baseline, after the first 3-week diet, and then after second 3-week diet)
- The change of quality of life(Survey for baseline, after the first 3-week diet, and then after second 3-week diet)