NCT03524638撤回不适用
Visbiome Effect on Colorectal Anastomosis and Local Recurrence
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Development of Anastomotic Leak
研究概览
简要总结
Determine whether the administration of Visbiome after colorectal surgery has any effect on anastomotic leak and local recurrence
详细描述
Randomized study of Visbiome after colorectal surgery. Subjects will be randomized 1:1 to either VSL3 or no VSL3.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Diagnosis of biopsy proven rectal cancer (CT/MRI)
- •Willing and able to comply with protocol requirements
- •Able to tolerate surgery
- •Able to comprehend and have signed the Informed Consent
- •Absence of metastatic disease
- •Clinical performance status of ECOG 0 or 1
- •Life expectancy of greater than 3 months
- •Planned ileostomy as part of their routine care
排除标准
- •Severe or refractory ulcerative colitis defined as Mayo Score of greater than or equal to 10, endoscopic disease activity score 3
- •Untreated enteric infection (positive stool test for any of the following: clostridium difficile, salmonella, shigella, yersinia, campylobacter, enteropathogenic E. coli or other enteric infection at the discretion of the Investigator
- •Severe immunodeficiency, inherited or required (e.g. HIV, chemotherapy or radiation therapy)
- •Patients with the following laboratory abnormalities: absolute neutrophil count <1000/ul, platelets <50 x 10^9/L, hemoglobin <6.5g/dL
- •History of anaphylaxis (severe allergic reaction) to food allergens (e.g. tree nuts, shellfish)
- •Active intestinal obstruction
- •Non-steroidal anti inflammatory medications (NSAIDs) as long-term treatment, defined as for at least 4 days per week each month
- •Cholestyramine use
- •Any condition in which the Investigator thinks VSL3 administration may pose a health risk (e.g. severely immunocompromised)
- •Simultaneous participation in another interventional clinical trial
- •Patients who are pregnant, breast feeding or planning pregnancy during study trial period
- •Patients with any other signification medical condition that could confound or interfere with evaluation of safety, tolerability or prevention compliance with the study protocol at the discretion of the Investigator
结局指标
主要结局
Development of Anastomotic Leak
时间窗: Hospital discharge, 2 and 4 weeks post-treatment. Then every 3 months for 1 year.
Development of anastomotic leak will be evaluated by sigmoidoscopy
Local Recurrence
时间窗: Every three months for 1 year post hospital discharge.
CT scans will be performed every 3 months after hospital discharge to check disease status
次要结局
未报告次要终点
研究者
Russell Farmer
Principal Investigator
University of Louisville
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