NCT00374725已完成不适用
Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus. A Randomised Placebo Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 3
- 主要终点
- Number of patients in remission in the two groups at the end of the treatment period
研究概览
简要总结
In this trial we test the hypothesis that a probiotic containing Lactobacillus acidophilus and Lactobacillus rhamnosus is an effective therapy for patients with ulcerative colitis.
详细描述
In the recent years there has been an increasing interest in the relationship between the gastrointestinal flora and gut function. Several studies have shown promising results for the use of probiotics in patient with inflammatory bowel disease.
In this trial approximately 100 patients with ulcerative colitis will receive treatment with probiotic or placebo for 8 to 10 months as adjuvant therapy.
The trial is double-blind, randomised and controlled.
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
- Double
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
- •Patients with known ulcerative colitis
- •At least one prior flare of the disease
- •Clinically and endoscopically active disease
- •Age: 18 and above
排除标准
- •Changes in azathioprine dosage within the last three months
- •Patients with toxic megacolon, peritoneal reaction or severe colonic bleeding
- •Known immunodeficiencies
- •On-going infectious disease
- •On-going treatment with NSAID or cholestyramine
- •Pregnant og lactating women
结局指标
主要结局
Number of patients in remission in the two groups at the end of the treatment period
次要结局
- Difference in time to relapse in the two treatment groups
- Number of patients successfully obtaining remission
- Time to remission in the two groups
- Time ro relapse after study treatment is discontinued
研究者
研究点 (3)
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