Faecal Microbiota Transplantation Using Stool From Normal Pouch Function Donor in the Treatment of Chronic Pouchitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Number of patients achieving clinical remission assessed by PDAI
研究概览
简要总结
Patients with chronic 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. The standard treatment for pouchitis is intensive broad-spectrum antibiotics for a longer period. However, the treatment often fails after repeated treatments. Studies show that patients with pouchitis have an altered composition of the gut microbiota compared to healthy individuals and patients with a pouch without inflammation. 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 to chronic pouchitis has been investigated in several clinical trials with mixed results. It is however still uncertain if faecal microbiota transplantation using stool from healthy individuals with a colon is optimal, or if stool from patient with a normally functioning pouch should be used.
The study primary aims to investigate if transplantation of faeces from patient with a normal pouch function can induce clinical remission in patients with chronic pouchitis.
详细描述
Hypothesis:
Gut dysbiosis plays a significant causal role in chronic pouchitis. Modulating the gut microbiota using FMT with stool from a normal function pouch patient has a clinical effect by inducing clinical remission in patients with chronic pouchitis.
Objective of the study:
The aim of the trial is to investigate if transplantation (FMT) of faeces from a patient with a normally functioning pouch can induce clinical remission in patients with chronic pouchitis.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 3 months
排除标准
- •Immunosuppression
- •Pregnancy or breastfeeding
- •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
- Number of patients achieving clinical response assessed by PDAI(4 weeks)
- Engraftment of the donor microbiota in the patients(4 weeks)
研究者
Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery
Professor of surgery, Consultant surgeon, DMSc
Aalborg University Hospital