Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Transplantation of Faeces in Ulcerative Colitis; Restoring Nature's Homeostasis.
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.


Options:
A: Arm Label: SER-109; Type: EXPERIMENTAL; Interventions: Biological: SER-109 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: BIOLOGICAL; Name: SER-109; Assigned to Arm(s): SER-109 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Fecal Microbiota Transplantation; Type: ACTIVE_COMPARATOR; Interventions: Biological: Fecal Microbiota Transplantation | Arm Label: Sham Fecal Microbiota Transplantation; Type: SHAM_COMPARATOR; Interventions: Biological: Sham Fecal Microbiota Transplantation | Intervention Type: BIOLOGICAL; Name: Fecal Microbiota Transplantation; Assigned to Arm(s): Fecal Microbiota Transplantation | Intervention Type: BIOLOGICAL; Name: Sham Fecal Microbiota Transplantation; Assigned to Arm(s): Sham Fecal Microbiota Transplantation
C: Arm Label: Fresh FMT; Type: EXPERIMENTAL; Interventions: Biological: Fresh FMT | Arm Label: Frozen-and-Thawed FMT; Type: EXPERIMENTAL; Interventions: Biological: Frozen-and-Thawed FMT | Intervention Type: BIOLOGICAL; Name: Fresh FMT; Assigned to Arm(s): Fresh FMT | Intervention Type: BIOLOGICAL; Name: Frozen-and-Thawed FMT; Assigned to Arm(s): Frozen-and-Thawed FMT
D: Arm Label: faecal transplantation; donor faeces; Type: ACTIVE_COMPARATOR; Interventions: Other: treatment with faecal transplantation (donor faeces) | Arm Label: faecal transplantation; placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: treatment with faecal transplantation (own faeces) | Intervention Type: OTHER; Name: treatment with faecal transplantation (donor faeces); Assigned to Arm(s): faecal transplantation; donor faeces | Intervention Type: OTHER; Name: treatment with faecal transplantation (own faeces); Assigned to Arm(s): faecal transplantation; placebo

Answer: D