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Background & Aims Several case series have reported the effects of fecal microbiota transplantation (FMT) for ulcerative colitis (UC). We assessed the efficacy and safety of FMT for patients with UC in a double-blind randomized trial. Methods Patients with mild to moderately active UC (n = 50) were assigned to groups that underwent FMT with feces from healthy donors or were given autologous fecal microbiota (control); each transplant was administered via nasoduodenal tube at the start of the study and 3 weeks later. The study was performed at the Academic Medical Center in Amsterdam from June 2011 through May 2014. The composite primary end point was clinical remission (simple clinical colitis activity index scores ≤2) combined with ≥1-point decrease in the Mayo endoscopic score at week 12. Secondary end points were safety and microbiota composition by phylogenetic microarray in fecal samples. Results Thirty-seven patients completed the primary end point assessment. In the intention-to-treat analysis, 7 of 23 patients who received fecal transplants from healthy donors (30.4%) and 5 of 25 controls (20.0%) achieved the primary end point ( P = .51). In the per-protocol analysis, 7 of 17 patients who received fecal transplants from healthy donors (41.2%) and 5 of 20 controls (25.0%) achieved the primary end point ( P = .29). Serious adverse events occurred in 4 patients (2 in the FMT group), but these were not considered to be related to the FMT. At 12 weeks, the microbiota of responders in the FMT group was similar to that of their healthy donors; remission was associated with proportions of Clostridium clusters IV and XIVa. Conclusions In this phase 2 trial, there was no statistically significant difference in clinical and endoscopic remission between patients with UC who received fecal transplants from healthy donors and those who received their own fecal microbiota, which may be due to limited numbers. However, the microbiota of responders had distinct features from that of nonresponders, warranting further study. ClinicalTrials.gov Number: NCT01650038.

Background and aims: The epidemiology of inflammatory bowel disease (IBD) is changing. In Europe, recent incidence and prevalence rates are lacking. The primary objective of this study is to update incidence and prevalence figures in a large well-phenotyped populationbased IBD cohort.Methods: All IBD patients living in the adherence area of 2 non-academic hospitals between 20042010 were identified. Patients were searched in 3 independent hospital databases case finding sources. 1378 Possible IBD cases were scrutinized, IBD diagnosis was based on established clinical, endoscopic and pathologic criteria. Location and behaviour of IBD was reported according to the Montreal classification. Results: 768 IBD patients were included. 255 (33.2%) patients were diagnosed with Crohn's disease (CD), 432 (56.3%) with ulcerative colitis (UC) and 81 (10.5%) with IBD-Unspecified (IBDU). The male-female ratio of IBD was 1:1.3 (P