A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effect of Mutaflor in Patients With Mild-to-moderate Ulcerative Colitis on 5-ASA Treatment.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Compare and evaluate the increase in IBDQ(Inflammatory bowel disease questionnaire) score between the Mutaflor group and the Placebo group
研究概览
简要总结
E.coli Nissle 1917 (Mutaflor®) is equivalent to mesalazine in preventing disease relapse in ulcerative colitis. However, data on ability of E.coli Nissle 1917 (Mutaflor®) to induce remission compared with placebo is limited. Investigators aim to investigate the efficacy of E.coli Nissle 1917 (Mutaflor®) as an add-on treatment to 5-ASA in mild to moderate ulcerative colitis.
详细描述
This is a multicentre, double-blind, randomised, placebo-controlled study in patients with mild-to-moderate UC.
Subjects were randomly assigned to receive either E.coli Nissle 1917 (Mutaflor®) or placebo once daily for 8 weeks, and inflammatory bowel disease questionnaire (IBDQ) scores, clinical remission, and response rate were compared.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ulcerative colitis patients over the age of 19 with mild to moderate symptoms using 5-ASA (Mayo score 3-9)
- •Patient who signed the consent form
排除标准
- •The extent of ulcerative colitis is limited to proctitis
- •History of bowel resection
- •History of using other medication than 5-ASA such as immunomodulators, steroid or biologics within 3months
- •history of using antibiotics or probiotics within 2 weeks
- •Pregnant or lactating woman
- •Requiring hospitalization and imminent need for surgery
研究组 & 干预措施
E. coli Nissle 1917 (Mutaflor®)
Active group will receive E. coli Nissle 1917 (Mutaflor®).
干预措施: E. coli Nissle 1917 (Mutaflor®) (Drug)
Placebo
Placebo group will receive placebo drug.
干预措施: Placebo (Drug)
结局指标
主要结局
Compare and evaluate the increase in IBDQ(Inflammatory bowel disease questionnaire) score between the Mutaflor group and the Placebo group
时间窗: 8weeks
The evaluation of the beneficial effects of Mutaflor on mild-to-moderate UC patients, was assessed by an increase in the IBDQ score more than 16 points from baseline to week 8. The Score can range from 32 to 224, with higher scores reflecting better HRQOL(Health-related quality of life)
次要结局
- Improvement in endoscopic scores between Mutaflor group and Placebo group(8weeks)
- Evaluate the clinical remission between Mutaflor group and Placebo group(4weeks, 8weeks)
- Evaluate the clinical response between Mutaflor group and Placebo group(4weeks, 8weeks)
- Evaluate the endoscopic response between Mutaflor group and Placebo group(8weeks)
- Evaluate the Microbiome(stool) change between Mutaflor group and Placebo group(8weeks)
研究者
Soo-kyung Park
Professor
Kangbuk Samsung Hospital