Transplantation of Faeces in Ulcerative Colitis; Restoring Nature's Homeostasis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- co-primary endpoint of clinical remission, as well as reduction of Mayo endoscopic inflammation score
研究概览
简要总结
Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) of the colon. Complaints such as abdominal pain, cramps and bloody diarrhoea usually start in early adulthood and lead to life-long substantial morbidity. There is no medical treatment available that meets the desired criteria of high efficacy versus low adverse effects. The current prevailing hypothesis regarding the cause of UC states that the pathogenesis involves an inappropriate and ongoing activation of the mucosal immune system driven by the intestinal microbiota in a genetically predisposed individual. Systematic investigation into the effect of correcting the dysbiosis in ulcerative colitis patients has never been performed. The most radical way to restore the presumably disturbed natural homeostasis in UC is to perform faecal transplantation from a healthy donor. In this trial the potential beneficial effects of restoring microbial homeostasis by faecal transplantation through a duodenal tube will be studied in a phase II randomised placebo controlled design.
Endpoints are clinical remission and reduction of endoscopic inflammation after 12 weeks (primary), as well as time to recurrence, intra individual changes in faecal samples and mucosal biopsies. Follow up is 12 months.
详细描述
treatment with faecal transplantation from a healthy donor in active ulcerative colitis patients. In this trial the potential beneficial effects of restoring microbial homeostasis by faecal transplantation through a duodenal tube will be studied in a phase II randomised placebo controlled 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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Ability to give informed consent
- •Established ulcerative colitis with known involvement of the left colon according to the Lennard-Jones criteria
- •SCCAI of 4 > < 11
- •Endoscopic Mayo score of > 1
- •Stable dose of thiopurines in preceding 8 weeks
- •Stable dose of corticosteroids and 5-ASA in preceding 2 weeks
排除标准
- •Condition leading to profound immunosuppression
- •Anti-TNF treatment in preceding 2 months
- •Cyclosporine treatment in preceding 4 weeks
- •Use of Methotrexate in preceding 2 months
- •Prednisolone dose > 10 mg
- •Life expectancy < 12 months
- •Use of systemic antibiotics in preceding 6 weeks
- •Use of probiotic treatment in preceding 6 weeks
- •Positive stool cultures for common enteric pathogens (Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic e coli)
- •Positive faecal PCR-test (positive PCR means: > 1 of the following viruses is present) for: Rotavirus, Norovirus, Enterovirus, Parechovirus Sapovirus, Adenovirus 40/41/
- •Astrovirus.
- •Pregnancy or women who give breastfeeding
- •Vasopressive medication, icu stay
研究组 & 干预措施
faecal transplantation; donor faeces
2 times treatment with faecal transplantation: faeces from a healthy donor processed for duodenal tube infusion. after bowel lavage with macrogol.
干预措施: treatment with faecal transplantation (donor faeces) (Other)
faecal transplantation; placebo
2 times treatment with (own) faecal transplantation: faeces from the patient processed for duodenal tube infusion. after bowel lavage with macrogol.
干预措施: treatment with faecal transplantation (own faeces) (Other)
结局指标
主要结局
co-primary endpoint of clinical remission, as well as reduction of Mayo endoscopic inflammation score
时间窗: at 12 weeks after treatment.
* clinical remission = questionnaire: SCCAI 2 or lower * reduction of Mayo endoscopic inflammation score= decrement of 1 or more as assessed by sigmoidoscopy
次要结局
- Frequency of bowel movements(start at baseline up to 6 weeks after treatment)
- Simple clinical colitis activity index (SCCAI) score reduction(time: 6 weeks after treatment)
- Time to recurrence(from timepoint 12 weeks after treatment up to 12 months)
研究者
C.Y. Ponsioen
MD PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)