The TURN trial, 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.

We hypothesize that faecal transplantation from a healthy donor can restore the dysbiosis present in UC patients, thereby inducing remission of the chronic inflammation of the colonic mucosa.

Week: 0, 3, 6, 12, 16, 24, 32, 40 and 52.

Arm 1: Patients will be treated with faecal transplantation, processed for duodenal-tube infusion;

Arm 2: Patients will be treated with their own faeces (placebo), processed for duodenal-tube infusion.