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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
Sponsor:
Information provided by (Responsible Party):
C.Y. Ponsioen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Tracking Information
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
 (submitted: August 6, 2012)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 25, 2012)
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
 (submitted: July 25, 2012)
  • 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 ]
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.

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
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Other: treatment with faecal transplantation (donor faeces)
    faecal transplantation
  • Other: treatment with faecal transplantation (own faeces)
    faecal transplantation
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Other: treatment with faecal transplantation (own faeces)
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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 28, 2014)
50
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2012)
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:

  • Age ≥ 18
  • 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

Exclusion Criteria:

  • 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 40/41/52. Astrovirus.
  • Pregnancy or women who give breastfeeding
  • Vasopressive medication, icu stay
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Principal Investigator: C Ponsioen, MD PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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