Transplantation of Faeces in Ulcerative Colitis; Restoring Nature's Homeostasis (TURN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01650038|
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : December 30, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Other: treatment with faecal transplantation (donor faeces) Other: treatment with faecal transplantation (own faeces)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Transplantation of Faeces in Ulcerative Colitis; Restoring Nature's Homeostasis.|
|Study Start Date :||May 2011|
|Primary Completion Date :||August 2014|
|Study Completion Date :||December 2014|
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)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650038
|Amsterdam, Netherlands, 1100DD|
|Principal Investigator:||C Ponsioen, MD PhD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|