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

Ulcerative Colitis Clinical Trial

— TURN  

Official title:

Transplantation of Faeces in Ulcerative Colitis; Restoring Nature's Homeostasis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650038
• Other study ID #: METC 2011_005
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2012
• Last updated: December 28, 2014
• Start date: May 2011
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Other:
• treatment with faecal transplantation (donor faeces)
faecal transplantation
• treatment with faecal transplantation (own faeces)
faecal transplantation

Locations

Country	Name	City	State
Netherlands	Academic_Medical_Center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Simple clinical colitis activity index (SCCAI) score reduction		time: 6 weeks after treatment	No
Secondary	Frequency of bowel movements		start at baseline up to 6 weeks after treatment	No
Secondary	Time to recurrence		from timepoint 12 weeks after treatment up to 12 months	No

External Links

•   Dutch trial register