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Transplantation of Faeces in Ulcerative Colitis; Restoring Nature's Homeostasis (TURN)

This study is currently recruiting participants.
Verified August 2012 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Information provided by (Responsible Party):
C.Y. Ponsioen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01650038
First received: July 18, 2012
Last updated: August 6, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Ulcerative Colitis
 Other: treatment with faecal transplantation (donor faeces)
Other: treatment with faecal transplantation (own faeces)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transplantation of Faeces in Ulcerative Colitis; Restoring Nature's Homeostasis.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • co-primary endpoint of clinical remission, as well as reduction of Mayo endoscopic inflammation score [ Time Frame: at 12 weeks after treatment. ] [ Designated as safety issue: No ]
    • clinical remission = questionnaire: SCCAI 2 or lower
    • reduction of Mayo endoscopic inflammation score= decrement of 1 or more as assessed by sigmoidoscopy


Secondary Outcome Measures:
  • Simple clinical colitis activity index (SCCAI) score reduction [ Time Frame: time: 6 weeks after treatment ] [ Designated as safety issue: No ]
  • Frequency of bowel movements [ Time Frame: start at baseline up to 6 weeks after treatment ] [ Designated as safety issue: No ]
  • Time to recurrence [ Time Frame: from timepoint 12 weeks after treatment up to 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
faecal transplantation
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)
faecal transplantation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650038

Contacts
Contact: C.Y. Ponisoen, MD PhD +3120-5666012 c.y.ponsioen@amc.uva.nl
Contact: N.G.M. Rossen, MD +3120-5662199 n.g.rossen@amc.uva.nl

Locations
Netherlands
Academic_Medical_Center Recruiting
Amsterdam, Netherlands, 1100DD
Principal Investigator: C Ponsioen, MD PhD            
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Principal Investigator: C Ponsioen, MD PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

Additional Information:
Dutch trial register  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: C.Y. Ponsioen, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01650038     History of Changes
Other Study ID Numbers: METC 2011_005
Study First Received: July 18, 2012
Last Updated: August 6, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
faecal transplantation
ulcerative colitis
inflammatory bowel disease

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013