Effects of Red Ginseng on Gastrointestinal Symptoms and Microbiota After Surgery for Gastrointestinal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in microbiome composition based on the consumption or non-consumption of red ginseng following gastrointestinal cancer surgery.
研究概览
简要总结
After surgery for gastrointestinal cancer (stomach cancer, pancreaticobiliary cancer, colorectal cancer), many patients experiences various symptoms such as weight loss, diarrhea, constipation and excessive gas due to structural and functional changes in the gastrointestinal tract. These changes are thought to be influenced by alterations in gut microbiota following surgery, but prospective studies are still lacking. It is anticipated that the prebiotic effects of red ginseng may lead to positive changes in total gut bactera after gastrointestinal caner surgery.
Through this study, Investigators aim to investigate the impact of red ginseng consumption on gut microbiota composition, gastrointestinal symptoms, and nutritional status improvement following surgery for gastrointestinal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The participating physicians in the study are kept unaware of which group each patient belongs to. However, patients are randomly divided into the Red ginseng and Control groups by research nurses, and they become aware of their group assignment (whether they will take red ginseng tablets or not) in a single-blind study format.
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically diagnosed with gastrointestinal cancers (stomach cancer, pancreatobiliary cancer, colorectal cancer) prior to surgery.
- •Clinically staged and anticipated to not receive adjuvant chemotherapy after surgery.
- •Eligible for complete surgical resection (R0 resection).
- •ASA (American Society of Anesthesiologists) score of 3 or below.
- •Intereseted in health functional foods.
- •Not consumed probiotics or prebiotics for at least three months prior to study enrollment.
- •Willing to refrain from consuming additional probiotics or prebiotics during the study period, apart from the provided red ginseng tablets.
排除标准
- •Patients aged 80 years or older.
- •Patients who received neoadjuvant therapy before surgery.
- •Patients with underlying gastrointestinal disorders (e.g., inflammatory bowel disease, ulcerative colitis, Crohn's disease, galactose intolerance, lactase deficiency, glucose-galactose malabsorption, short bowel syndrome, other hereditary gastrointestinal diseases, and autoimmune diseases).
- •Patients unable to orally consume red ginseng tablets.
- •Patients with a history of previous abdominal organ surgery, radiation therapy, or chemotherapy.
- •Patients with intestinal obstruction before surgery.
- •Patients regularly taking probiotic or prebiotic supplements.
- •Patients requiring formation of an ileostomy after surgery.
- •Patients with uncontrolled diabetes that may affect gastrointestinal function.
- •Patients with underlying conditions such as liver failure or renal failure.
- •Patients allergic to red ginseng.
- •Patients who received more than two weeks of antibiotic treatment during hospitalization.
结局指标
主要结局
Changes in microbiome composition based on the consumption or non-consumption of red ginseng following gastrointestinal cancer surgery.
时间窗: 4 months after surgery
We observe changes in total gut bacteria following gastrointestinal cancer surgery based on the consumption of red ginseng through analysis of fecal microbiome.
次要结局
- Improvement of gastrotintestinal symptoms(4 months after surgery)
- Improvement of bowel habits(4 months after surgery)
- Nutritional Indicator(4 months after surgery)
- Nutritional Indicators(4 months after surgery)
研究者
In Gyu Kwon
Associate Professor
Gangnam Severance Hospital