NCT00175292已完成3 期
A Randomized and Placebo-Controlled Double-Blind Multicentre Study to Determine the Efficacy and Safety of VSL#3 Probiotic Food Supplement Mixture in Prevention of Endoscopic Recurrence in Crohn's Disease Patients With Ileocolonic Surgical Resection and Small Intestine to Colon Anastomosis.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 18
- 主要终点
- Prevention of severe endoscopic recurrence of Crohn's disease.
研究概览
简要总结
This randomized placebo-controlled double-blind, multi-centre trial will determine the efficacy of the probiotic VSL#3 in the prevention of Crohn's disease development following surgical resection and re-anastomosis. A total of 120 patients will be randomly assigned in a 1:1 ratio to receive VSL#3 or placebo for 90 days. Patients who respond to study treatment, as defined by the absence of a severe endoscopic recurrence at day 90, will be offered open-label VSL#3 for an additional 9 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 16 years of age or older
- •Diagnosis of Crohn's disease
- •Resection of ileocolonic Crohn's disease and small bowel to colonic anastomosis within 30 days of randomization
- •Able to provide informed written consent
- •Women of child-bearing potential with a negative serum pregnancy test, and/or use of effective contraception
排除标准
- •Use of perioperative steroids in tapering doses and anti-diarrheal agents
- •Treatment with a TNF-antagonist in the 8 weeks prior to resection
- •Clinically significant Crohn's disease elsewhere in the GI tract
- •Clinically documented short bowel syndrome
- •Serious disease other than Crohn's disease
- •Impaired liver or renal function
- •History of cancer with less than 2 years disease-free state
- •Abnormal Laboratory values
- •Alcohol or drug abuse
- •Some psychiatric conditions
- •Patients using other study medications
- •Patients who are unable to attend study visits or comply with study procedures
- •Positive pregnancy test
结局指标
主要结局
Prevention of severe endoscopic recurrence of Crohn's disease.
次要结局
- Endoscopic recurrence at 90 days and 360 days
- Crohn's Disease Activity Index (CDAI)
- Quality of life
- Safety and tolerance of VSL#3
研究者
研究点 (18)
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