NCT00268164终止2 期
Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Number of patients with relapse at 12 month.
研究概览
简要总结
The purpose of this study is to determine whether the lactic acid bacteria " Lactobacillus acidophilus (LA5) and Bifidobacterium animalis subsp. lactis (BB12)" is effective as maintenance treatment in ulcerative colitis.
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 ulerative colitis ording to well-known diagnostic criteria and remission for at least one month, and with at least one relapse within the last year.
排除标准
- •Pregnancy and lactating
- •Serious underlying disease other than UC
- •Former gastrointestinal resections
- •Medication for UC other than mesalazine
- •Known allergic reactions towards compounds in the study drug.
- •Expected lack of compliance due to mental state or language problems
结局指标
主要结局
Number of patients with relapse at 12 month.
次要结局
- Number of days to relapse.
- Presence and concentrations of the probiotic bacterial strains in stool.
- Safety and tolerance of the probiotic mixture.
研究者
研究点 (2)
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