Transplantation of Faeces in Ulcerative Colitis; Restoring Nature's Homeostasis (TURN)
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.
|Ulcerative Colitis||Other: treatment with faecal transplantation (donor faeces) Other: treatment with faecal transplantation (own faeces)||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Transplantation of Faeces in Ulcerative Colitis; Restoring Nature's Homeostasis.|
- co-primary endpoint of clinical remission, as well as reduction of Mayo endoscopic inflammation score [ Time Frame: 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
- Simple clinical colitis activity index (SCCAI) score reduction [ Time Frame: time: 6 weeks after treatment ]
- Frequency of bowel movements [ Time Frame: start at baseline up to 6 weeks after treatment ]
- Time to recurrence [ Time Frame: from timepoint 12 weeks after treatment up to 12 months ]
|Study Start Date:||May 2011|
|Study Completion Date:||December 2014|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Active Comparator: 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.
Other: treatment with faecal transplantation (donor faeces)
Placebo Comparator: faecal transplantation; placebo
2 times treatment with (own) faecal transplantation: faeces from the patient processed for duodenal tube infusion. after bowel lavage with macrogol.
Other: treatment with faecal transplantation (own faeces)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650038
|Amsterdam, Netherlands, 1100DD|
|Principal Investigator:||C Ponsioen, MD PhD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|