Comparison of Probiotic Effects of Lactobacillus Casei Shirota With Lactobacillus Acidophilus on the Outcomes of Patients After Colorectal Cancer Surgery: A Study of Gastrointestinal Function, Sepsis Incidence, C-Reactive Protein, Interleukin 6 and Length of Stay
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Gastrointestinal Function
研究概览
简要总结
This clinical trial aims to compare the effects of administering Lactobacillus casei Shirota probiotics with Lactobacillus acidophilus on the outcomes of patients after colorectal cancer surgery. Researchers will compare probiotic to see if Lactobacillus casei Shirota improves gastrointestinal function, sepsis incidence, C-reactive protein (CRP), interleukin 6 (IL-6), and length of stay better than Lactobacillus acidophilus. Participants will take probiotics three times daily for three days before surgery.
详细描述
The research design was a two-group unblinded, randomized clinical trial in 90 adult patients undergoing colorectal cancer surgery who are treated in the ICU, HCU and wards of Dharmais Cancer Hospital. Subjects who meet the criteria are divided into 2 (two) groups: the group given Lactobacillus casei Shirota and Lactobacillus acidophilus probiotics. Assessment of gastrointestinal function using the I-FEED score for early feeding was carried out on the second day after surgery. Sepsis diagnosis used the NEWS2 scoring assessed on the second, fourth, and sixth days of treatment. CRP levels were measured three times, namely during perioperative visit before surgery, four hours before surgery and three days after surgery. IL-6 levels were measured twice, namely perioperative visit before surgery and three days after surgery. Length of stay was calculated from after surgery until the patient was discharged.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Patients who were diagnosed with colorectal cancer and would undergo resection surgery at Dharmais Cancer Hospital
排除标准
- •The patient or patient's family refused to be included in the study
- •Patients with chronic diseases such as HIV, uncontrolled diabetes mellitus (, uncontrolled cardiovascular disease and kidney failure
- •Patients with a history of regular probiotics, or steroids, or antibiotics consumption
- •Patients with anatomical disorders of the gastrointestinal system
- •Patients with immunocompromised conditions.
研究组 & 干预措施
Lactobacillus casei Shirota Group
Participants were given probiotic liquid beverage containing 6,5x10^9 CFU of Lactobacillus casei Shirota strain
干预措施: Lactobacillus casei Shirota (Biological)
Lactobacillus acidophilus Group
Participants were given Probiotic capsule containing 10^9 CFU of Lactobacillus acidophilus strain
干预措施: Lactobacillus acidophilus (Biological)
结局指标
主要结局
Gastrointestinal Function
时间窗: Second day of treatment in the ICU
Assessed using I-FEED score which measures postoperative gastrointestinal function that contains five elements (intake, response to nausea treatment, emesis, examination, and duration, each scored with 0, 1, or 3 points) and classifies patients into normal, postoperative gastrointestinal intolerance (POGI), and postoperative gastrointestinal dysfunction (POGD)
Sepsis Incidence
时间窗: second, fourth, and sixth days of treatment
Assessed using NEWS2 to determine patient's degree of illness and prompts critical care intervention
C-reactive protein (CRP)
时间窗: Baseline, four hours before surgery and three days after surgery
CRP is a protein synthesized in the liver and will increase in response to inflammation. Baseline CRP data was collected on the same day the patient visited the oncology clinic before surgery and before probiotic consumption
Interleukin 6 (IL-6)
时间窗: Baseline and three days after surgery
IL-6 is a soluble mediator that has several functions in the immune response. IL-6 is produced in response to infection or tissue trauma. Baseline IL-6 data was collected on the same day the patient visited the oncology clinic before surgery and before probiotic consumption.
Length of stay
时间窗: Up to 16 days (documented maximum length of stay)
The number of days of patient care after undergoing colorectal cancer surgery until the patient can be treated as an outpatient
次要结局
未报告次要终点
研究者
Berial Dewin Marzaini
Principal Investigator
Dharmais National Cancer Center Hospital