NCT04266106Unknown3 期
Effect of Perioperative Probiotics on Clinical Outcomes of Patients Undergoing Major Abdominal Operation in Community Settings - 2
Jan Franko, MD1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Quality of Life
研究概览
简要总结
This prospective randomized trial is designed to test a pragmatic simple intervention in a community hospital. The trial will test the hypothesis whether patient recovery after a major elective abdominal operation can be improved and/or accelerated with postoperative use of probiotics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adults aged ≥18 years undergoing elective major abdominal operation
- •Functional GI tract expected after operation
排除标准
- •Current episode of acute necrotizing pancreatitis as defined by surgeon
- •Palliative decompressive GI tube
- •Life expectancy ≤ 6 months
- •Systemic immune-mediated disease active requiring systemic therapy:
- •Prednisone ≥20 mg QD
- •IV immunoglobulins
- •Anti-rejection medication
- •Presence of functional transplanted organ
- •Systemic collagen-related disease treated with immunomodulating agents, including rheumatoid arthritis, SLE, scleroderma, etc.
- •Topical chemotherapy or corticosteroids, and chemotherapy applied during operation are allowed
- •Patient taking probiotics, synbiotics, or cobiotics as part of their lifestyle
- •Need for full systemic anticoagulation postoperatively.
研究组 & 干预措施
probiotic
Experimental
干预措施: SuperBio probiotic (Drug)
Placebo Comparator
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Quality of Life
时间窗: up to 2 months
Functional Assessment of Cancer Therapy (FACT) G7 score: higher value corresponds with better QoL, range 0-28 points
次要结局
未报告次要终点
研究者
Jan Franko, MD
Chair of Surgical Oncology
MercyOne Des Moines Medical Center
研究点 (1)
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