Transplantation of Faeces in Ulcerative Colitis; Restoring Nature's Homeostasis
TURN
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2011
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 18, 2012
CompletedFirst Posted
Study publicly available on registry
July 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedDecember 30, 2014
December 1, 2014
3.3 years
July 18, 2012
December 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
co-primary endpoint of clinical remission, as well as reduction of Mayo endoscopic inflammation score
* clinical remission = questionnaire: SCCAI 2 or lower * reduction of Mayo endoscopic inflammation score= decrement of 1 or more as assessed by sigmoidoscopy
at 12 weeks after treatment.
Secondary Outcomes (3)
Simple clinical colitis activity index (SCCAI) score reduction
time: 6 weeks after treatment
Frequency of bowel movements
start at baseline up to 6 weeks after treatment
Time to recurrence
from timepoint 12 weeks after treatment up to 12 months
Study Arms (2)
faecal transplantation; donor faeces
ACTIVE COMPARATOR2 times treatment with faecal transplantation: faeces from a healthy donor processed for duodenal tube infusion. after bowel lavage with macrogol.
faecal transplantation; placebo
PLACEBO COMPARATOR2 times treatment with (own) faecal transplantation: faeces from the patient processed for duodenal tube infusion. after bowel lavage with macrogol.
Interventions
faecal transplantation
faecal transplantation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Academic_Medical_Center
Amsterdam, 1100DD, Netherlands
Related Publications (1)
Rossen NG, Fuentes S, van der Spek MJ, Tijssen JG, Hartman JH, Duflou A, Lowenberg 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.
PMID: 25836986DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
C Ponsioen, MD PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
July 18, 2012
First Posted
July 26, 2012
Study Start
May 1, 2011
Primary Completion
August 1, 2014
Study Completion
December 1, 2014
Last Updated
December 30, 2014
Record last verified: 2014-12