A Randomized Double-Blind Trial of Perioperative Administration of Probiotics in Colorectal Cancer Patients.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Primary Efficacy Parameters: morphological and microbiological evaluation of the colonic microflora, gastrointestinal function
研究概览
简要总结
Design: double blind controlled randomized trial with a parallel design and 3 treatment groups Description of subjects: Patients admitted in study centers for colorectal surgery under laporoscopy and/or laparotomy.
Product:
Product 1: BB536 and LA1 (10E9) Product 2: BB536 and LA1 (10E7) Placebo: Maltodextrin Number of patients: enrolled subjects: n=33, ITT data set: n=31, PP data set: n=30
Primary objective:
Colonization (biopsy+stools) of each bacteria for one of the dose at D0 (surgical procedure)
Secondary objectives:
- Influence of the probiotic bacteria on the gut microflora
- Modulation of the immune and inflammatory response
Additional objectives:
- Investigate dose effect on La1 colonization
- Investigate the effect of La1 colonization, treatment without La1 colonization, and absence of treatment and La1 colonization on other bacteria and on immunological parameters
详细描述
BACKGROUND AND RATIONALE
The administration of probiotic bacteria has been hypothesized to affect the composition of the intestinal microflora with reduction of pathogens in favour of non-pathogens. These events might modulate the immune and inflammatory responses, and the gut function.
Experimental data demonstrated that the modulation of the mucosal function and enteric microflora by Lactobacillus plantarum reduces septic morbidity and mortality in animals. The administration of a mix of probiotics has been shown to be more effective than antibiotics to cure pouchitis in humans.
Since patients undergoing colorectal operations have a high risk to develop infections due to the intraoperative contamination with enteral content and the occurence of bacterial translocation, changing the intestinal microflora, by giving lactobacilli may result in important advantages to reduce the risk of intraoperative complications and post operative sepsis.
OBJECTIVES OF THE STUDY
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Males and females between 18 and 80 years of age
- •Documented cancer disease of the colorectum as diagnos pre-operatively by positive histology.
- •Documented bowel disease (IBD, diverticular disease etc) as diagnosed by barium X-Ray or endoscopy.
- •Elective colorectal surgery
- •Surgical hospital length of stay anticipated to be at least 8 days
- •Stool sample available at Day-3 pre-operatively
- •Receiving full enteral / oral nutrition
- •Written informed consent (by subject or legal guardian)
排除标准
- •Perioperative unresectable tumours
- •Perioperative neoplastic ascitis
- •Emergency colorectal surgery
- •Clinically relevant pulmonary or cardiovascular failure
- •Liver failure (known cirrhosis or total bilirubin >3 mg/dl)
- •Kidney failure (receiving renal dialysis or serum creatinine >2 mg/dl)
- •Patients receiving total parenteral nutrition (TPN)
- •Immunological disorders
- •Ongoing or recent infections (within last 10 days)
- •Pregnant (patient's declaration)
- •Participation in another clinical trial
- •SUBJECT SELECTION CRITERIA
- •Population Base: Patients with diagnosis of disease of the colorectum, elective for colorectal surgery
- •Inclusion Criteria:
- •Both sexes with age greater than 18 years.
- •Documented disease of the colorectum, candidate to major elective surgery.
- •Provided written informed consent.
- •Exclusion Criteria
- •Preoperative:
- •clinically relevant failure of the pulmonary
- •cardiovascular, renal or hepatic system
- •ongoing bleeding
- •immunological disorder
- •ongoing or recent infections
- •emergency surgery
- •Intraoperative:
- •unresectable tumors
- •neoplastic ascitis
结局指标
主要结局
Primary Efficacy Parameters: morphological and microbiological evaluation of the colonic microflora, gastrointestinal function
次要结局
- Secondary Efficacy Parameters: immune and inflammatory response, bacterial translocation