The Effect of Faecal Microbiota Transplantation in the Treatment of Chronic Pouchitis: A Multicentre, Placebo-controlled, Randomized, Double Blinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Number of patients achieving clinical remission assessed by PDAI
研究概览
简要总结
Patients with the chronic bowel disease pouchitis is disabled by bloody diarrhoea and abdominal pain often followed by fever. Pouchitis is an inflammation in a pouch, a reservoir formed by the small intestine in the management of the chronic inflammatory bowel disease, ulcerative colitis. Chronic pouchitis is a rare disease with a prevalence in Denmark of <1.8 per 10,000 people, mostly younger people (<50 years). The standard treatment for pouchitis is intensive broad-spectrum antibiotics for a longer period. However, the treatment often fails after repeated treatments. Recent studies show that patients with pouchitis have an altered composition of the gut flora, called microbiota, compared to healthy individuals. As shown by several studies, faecal microbiota transplantation (FMT) with administration of faeces from healthy donors can alter the microbiota. Treatment with faecal microbiota transplantation is today known to be the ultimate treatment for antibiotic resistant recurrent bowel infection with the bacteria Clostridium difficile. It is however still uncertain if faecal microbiota transplantation can be used to the treatment of chronic pouchitis.
The study primary aims to investigate if transplantation of faeces from healthy donors administrated as enemas to patients with chronic pouchitis is superior to placebo for the treatment of pouchitis.
The project is designed as a multi-center, double-blinded, randomized, placebo-controlled treatment study. A positive result from the project will result in an improved treatment to pouchitis patients. Moreover, repeated long-lasting broad-spectrum treatments with antibiotic, which carry a high risk of antibiotic resistance in the society, will be avoided.
详细描述
Hypothesis:
Gut dysbiosis plays a significant causal role in chronic pouchitis. Modulating the gut microbiota using FMT has a clinical effect by inducing clinical remission in patients with chronic pouchitis.
Objective of the study:
The aim of the MicroPouch-trial is to investigate if transplantation (FMT) of faeces from healthy donors to patients with chronic pouchitis is clinical significant to placebo for the treatment of pouchitis.
Study design:
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, Outcomes Assessor)
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 ≥ 18 years of age with a J-pouch
- •Established diagnosis of chronic pouchitis (≥3 times of pouchitis within the last year, symptoms more than 4 weeks despite antibiotic treatment)
- •Antibiotic treatment for pouchitis (ciprofloxacin and/or metronidazole) within the last year
- •Not pregnant or breastfeeding
排除标准
- •Immunosuppression
- •Pregnancy
- •Evidence of intestinal pathogen bacteria in the stool at inclusion visit
- •Any severe or newly diagnosed concomitant cardiovascular, hepatic, intestinal, renal, endocrine, pulmonary, dental disease with inflammation or psychiatric disorder, which, in the opinion of the investigator, might have an influence on the patient's compliance or the interpretation of the results
- •Probiotic intake within the last 2 weeks prior to study intervention
- •Participation in another clinical trial within the previous 30 days before baseline
- •Serious food allergies with earlier anaphylactic reactions
结局指标
主要结局
Number of patients achieving clinical remission assessed by PDAI
时间窗: 4 weeks
Clinical remission is defined as PDAI\<7
次要结局
- Engraftment of the donor microbiota in the patients assessed by beta-diversity(12 months)
- Number of patients relapsing(12 months)
- Number of patients achieving clinical response assessed by PDAI(4 weeks)
- Number of patients experience improvement in quality of life assessed by the patient-reported questionnaire SIBDQ(4 weeks)
- Number of patients with treatment-related adverse events in the FMT group compared to the placebo group(12 months)
- Increase of the faecal microbiota biodiversity assessed by alpha-diversity(12 months)
研究者
Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery
Professor
Aalborg University Hospital