The Efficacy of Mutaflor(E. Coli Nissle 1917, Mutaflor®) for Chronic Constipation:Multicenter Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Relief of constipation defined by improvement of complete spontaneous bowel movements(CSBMs/week)
研究概览
简要总结
Chronic constipation is a prevalent, burdensome gastrointestinal disorder whose treatment remains challenging. There exist effective pharmacological therapies for chronic constipation, however, many patients do not well respond to current medications. Evidence suggests that disturbance in the gastrointestinal microbiota may be implicated in chronic constipation. Although, E.coli Nissle 1917 (Mutaflor®) has been used for chronic constipation, there are limited data regarding the efficacy of E.coli Nissle 1917 (Mutaflor®) in these patients. Therefore, this study aimed to investigate the efficacy of E.coli Nissle 1917 (Mutaflor®) in patients with chronic constipation.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult male or female outpatients aged from 20 to 75 years old.
- •Patients meet International Congress of Gastroenterology (ROME III) clinical criteria for constipation*:
- •A. Must include two or more of the following:
- •Straining in > 1/4 defecations;
- •Lumpy or hard stools > 1/4 defecations;
- •Sensation of incomplete evacuation in 1/4 defecations;
- •Sensation of anorectal obstruction/blockage in > 1/4 defecations;
- •<3 defecations/week.
- •B.Loose stools are rarely present without the use of laxatives. C.There are insufficient criteria for irritable bowel syndrome. *Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
排除标准
- •Pregnant or lactating woman
- •Known organic gastrointestinal disease
- •Subjects who diagnosed advanced adenoma within 3 years
- •Prior gastrointestinal surgery (except appendectomy, herniotomy)
- •Subjects who diagnosed irritable bowel syndrome
- •Use of one or more of listed medications within 2 weeks (Laxative, Metoclopramide, Domperidone, Itopride, Levosulpride, Cisapride, Mosapride, Tegaserod, Prucalopride, Renzapride, Erythromycin, buspirone, Sumatriptan, Alosetron, Cilansetron, ondansetron, Citalopram, Paroxetine, Baclofen, Sildenafil, Nitroglycerin)
- •Subjects who diagnosed lactulose malabsorption
- •Subjects who diagnosed liver cirrhosis, severe congestive heart failure, severe renal insufficiency, uncontrolled hypertension, endocrine disorder, metabolic disorder, prior malignancy, immune deficiency
- •Suspected obstruction, gastric retention, ileus, perforation, fecal impaction or inflammatory bowel disease.
研究组 & 干预措施
E. coli Nissle 1917 (Mutaflor®)
Mutaflor® group will receive E. coli Nissle 1917 (Mutaflor®) 28mg 2T tid for initial 2 days, then E. coli Nissle 1917, Mutaflor® 4T qd for the next 26 days.
干预措施: E. coli Nissle 1917(Mutaflor®) (Drug)
Matched placebo
Matched placebo group will receive placebo drug 28mg 2T tid for initial 2 days, then placebo 4T qd for the next 26 days. Placebo drug has same shape and size with E. coli Nissle 1917 (Mutaflor®).
干预措施: Placebo (Drug)
结局指标
主要结局
Relief of constipation defined by improvement of complete spontaneous bowel movements(CSBMs/week)
时间窗: 28days
Subjects will report symptoms by questionnaire
次要结局
- Improvement of average number of CSBMs/week(28days)
- Improvement of constipation related symptom(28days)
- The time to 1st CSBM or SBM(28days)
- Improvement of constipation related quality of life(28days)
研究者
YooJin Lee
Professor
Keimyung University Dongsan Medical Center