Skip to main content
OpenTrials
Completed

NCT Number: NCT01650038

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Academic_Medical_Center

Amsterdam, 1100DD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

treatment with faecal transplantation (donor faeces)

Other

faecal transplantation

treatment with faecal transplantation (own faeces)

Other

faecal transplantation

Primary outcomes

  1. 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

Secondary outcomes

  1. Simple clinical colitis activity index (SCCAI) score reduction

    Time frame: time: 6 weeks after treatment

  2. Frequency of bowel movements

    Time frame: start at baseline up to 6 weeks after treatment

  3. Time to recurrence

    Time frame: from timepoint 12 weeks after treatment up to 12 months

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

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

Acronym: TURN

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 26, 2012
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.