The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome After Anterior Resection of Colon Cancer; Double-blind, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Anterior resection syndrome improvement change
研究概览
简要总结
The purpose of this clinical trial study was to evaluate the prevalence of colon cancer among the symptom (s) of anterior resection syndrome that may occur after surgery in patients for efficacy and safety in Metchnik probiotic ingestion.
详细描述
The purpose of the clinical trial is to evaluate the efficacy and safety of the syndrome that may occur after colon cancer surgery, To evaluate the efficacy and safety of the improvement effect of the defecatory activity on the improvement of the Medienkov probiotics biotics on the patients who have the deficit function and planned to surgery.
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 (Care Provider)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult male or female aged 20 to over 75 years old
- •As histologically and radiologically diagnosed S colon cancer, those who is scheduled for anterior resection
- •Those who have been agreed to participate in this trial (through Informed consent) before initiation of clinical trial.
排除标准
- •Those who have metastatic colorectal cancer screening
- •Those who have urinary incontinence or fecal incontinence
- •Those who received preoperative chemotherapy or radiotherapy
- •Those who have a history of severe cerebral vascular disease (cerebral infarction, cerebral hemorrhage, etc.), severe cardiac disease (unstable angina pectoris, myocardial infarction, arrhythmia requiring heart failure heart failure therapy)
- •Those who have neurologist or psychologically important psychiatric history or current disease
- •Those who have alcohol addiction, substance abuse
- •Those who have Immune system, infectious infectious disease, gastrointestinal tract disease patients (inflammatory bowel disease)
- •Those who have uncontrolled hypertension, diabetes patients
- •Those who have creatinine with more than twice from normal upper limit in site
- •Those who have AST(GOT) or ALT(GPT) with more than three times from normal upper limit in site
- •Those who have probiotics, antibiotics, continually within the last one week
- •Those who is pregnant women, breastfeeding women and have pregnancy plans or do not agree to appropriate contraception methods choice
- •Those who have been participated within three months or have plans to participate in another clinical trial after the start of this clinical trial
- •under the investigator's judgment, those who is not qualified to participate this clinical trial
研究组 & 干预措施
Experimental
Using placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one.
The patients enrolled into expeimental group will take one pack of 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery.
(1 week before surgery and 3 weeks after surgery)
The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer'
干预措施: Mechnicov probiotics (Drug)
Placebo comparator
Using placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one.
The patients enrolled into placebo comparator group will take one pack of 'Placebo' which is composed of lactose and simulates a 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery.
(1 week before surgery and 3 weeks after surgery)
The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer'
干预措施: Placebo (Drug)
结局指标
主要结局
Anterior resection syndrome improvement change
时间窗: 1 week before surgery, 4 weeks after surgery, 5 weeks after surgery
3 times performed through questionnaire
次要结局
- Quality of Life of Cancer Patients(EORTC QLQ-C30)(1 week before surgery, 4 weeks after surgery)
- NGS, SCFA(1 week before surgery, 1 week after surgery, 4 weeks after surgery, 5 weeks after surgery)
- Bowel examination(4 weeks after surgery, 5 weeks after surgery)
- Markers related Inflammation(1 week before surgery, 4 weeks after surgery)
- NSI(Nutritional Screening Index)(1 week before surgery, 1.5 weeks after surgery, 4 weeks after surgery)
- Clavien-Dindo Classification(1 week after surgery, 1.5 weeks after surgery, 4 weeks after surgery)
- Other biomarkers(1 week before surgery, 4 weeks after surgery)
研究者
Kye Bong-Hyeon
Associate Professor
The Catholic University of Korea