Transplantation of Faeces in Ulcerative Colitis; Restoring Nature's Homeostasis (TURN)
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ClinicalTrials.gov Identifier: NCT01650038 |
Recruitment Status :
Completed
First Posted : July 26, 2012
Last Update Posted : December 30, 2014
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Tracking Information | ||||
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First Submitted Date ICMJE | July 18, 2012 | |||
First Posted Date ICMJE | July 26, 2012 | |||
Last Update Posted Date | December 30, 2014 | |||
Study Start Date ICMJE | May 2011 | |||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
co-primary endpoint of clinical remission, as well as reduction of Mayo endoscopic inflammation score [ Time Frame: at 12 weeks after treatment. ]
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Original Primary Outcome Measures ICMJE |
co-primary endpoint of clinical remission, as well as reduction of Mayo endoscopic inflammation score [ Time Frame: at 12 weeks after treatment. ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Transplantation of Faeces in Ulcerative Colitis; Restoring Nature's Homeostasis | |||
Official Title ICMJE | Transplantation of Faeces in Ulcerative Colitis; Restoring Nature's Homeostasis. | |||
Brief Summary | 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. |
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Detailed Description | 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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Ulcerative Colitis | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Rossen NG, Fuentes S, van der Spek MJ, Tijssen JG, Hartman JH, Duflou A, Löwenberg M, van den Brink GR, Mathus-Vliegen EM, de Vos WM, Zoetendal EG, D'Haens GR, Ponsioen CY. Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis. Gastroenterology. 2015 Jul;149(1):110-118.e4. doi: 10.1053/j.gastro.2015.03.045. Epub 2015 Mar 30. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
50 | |||
Original Estimated Enrollment ICMJE |
40 | |||
Actual Study Completion Date ICMJE | December 2014 | |||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Netherlands | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01650038 | |||
Other Study ID Numbers ICMJE | METC 2011_005 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | C.Y. Ponsioen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | |||
Study Sponsor ICMJE | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | |||
Verification Date | December 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |