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Background: Faecal microbiota transplantation (FMT) is an emerging treatment modality, but its current clinical use and organisation are unknown. We aimed to describe the clinical use, conduct, and potential for FMT in Europe. Methods: We invited all hospital-based FMT centres within the European Council member states to answer a web-based questionnaire covering their clinical activities, organisation, and regulation of FMT in 2019. Responders were identified from trials registered at clinicaltrials.gov and from the United European Gastroenterology (UEG) working group for stool banking and FMT. Findings: In 2019, 31 FMT centres from 17 countries reported a total of 1,874 (median 25, quartile 10–64) FMT procedures; 1,077 (57%) with Clostridioides difficile infection (CDI) as indication, 791 (42%) with experimental indications, and 6 (0•3%) unaccounted for. Adjusted to population size, 0•257 per 100,000 population received FMT for CDI and 0•189 per 100,000 population for experimental indications. With estimated 12,400 (6,100–28,500) annual cases of multiple, recurrent CDI and indication for FMT in Europe, the current European FMT activity covers approximately 10% of the patients with indication. The participating centres demonstrated high safety standards and adherence to international consensus guidelines. Formal or informal regulation from health authorities was present at 21 (68%) centres. Interpretation: FMT is a widespread routine treatment for multiple, recurrent CDI and an experimental treatment. Embedded within hospital settings, FMT centres operate with high standards across Europe to provide safe FMT. A significant gap in FMT coverage suggests the need to raise clinical awareness and increase the FMT activity in Europe by at least 10-fold to meet the true, indicated need. Funding: NordForsk under the Nordic Council and Innovation Fund Denmark (j.no. 8056–00006B).

Background and Aim Health-related quality of life (HRQoL) is impaired in patients with Crohn's disease (CD). This study aimed to identify the impact of clinical disease activity on HRQoL in CD patients treated with biological agents. Methods Patients with moderate to severe active CD treated with biological agents in Denmark were included from 2016-2018. Disease related symptoms were assessed via the Harvey Bradshaw Index. HRQoL was measured on the Short Health Scale (SHS). Multivariable linear regression models were conducted separately for each SHS item and average SHS score stratified for sex, adjusting for clinical manifestation and age. Results In total, 1,181 CD patients were included. The mean age was 33 years and 56% were women. Abdominal pain (range of regression coefficients 1.18-1.42), number of liquid stools (0.33-0.58), and the appearance of a new rectal fistula (0.91-1.32) affected all domains in the SHS negatively for men and women. Arthralgia (0.47-0.67) and abdominal mass (0.54-0.62) affected 4 out of 5 items on SHS negatively for women and men, respectively. Female sex was found a predictor of lower HRQoL across all SHS items, whereas age and fistulizing disease, as phenotype, were not associated with lower HRQoL. Conclusions Abdominal pain, number of liquid stools, a new rectal fistula, arthralgia for women, clinically assessed abdominal mass for men as well as female sex, were all found to be predictors of decreased HRQoL.

Background: Data from real-life populations about vedolizumab as first-line biological therapy for ulcerative colitis (UC) and Crohn’s disease (CD) are emerging. Objective: To investigate the efficacy and safety of vedolizumab in bio-naïve patients with UC and CD. Methods: A Danish nationwide cohort study was conducted between November 2014 and November 2019. Primary outcomes were clinical remission, steroid-free clinical remission, and sustained clinical remission from weeks 14 through 52. Results: The study included 56 patients (UC:31, CD:25) who initiated treatment with vedolizumab mainly because of contraindications to anti-TNFs, of whom 54.8 and 24.0%, respectively received systemic steroids at the initiation. Rates of clinical remission at weeks 6, 14, and 52 were 32.0, 48.0, and 40.0%, respectively, in UC, and 36.8, 36.8, and 47.4% in CD. Steroid-free clinical remission at week 52 was achieved among 36.0 and 47.4% of UC and CD patients, while sustained clinical remission was achieved in 32.0 and 36.8%. Lack of remission was associated with being female (68.8 vs. 11.1%, p =.01) in UC and non‐structuring, non‐penetrating behavior in CD (90.0 vs. 44.4%, p =.03); however, this was not confirmed in multivariate analysis. Discontinuation due to primary non-response occurred in 20.0 and 5.3% of UC and CD patients, respectively, while rates of secondary loss of response were 12.0 and 5.3% after 52 weeks of follow-up. Vedolizumab was well-tolerated as only one UC patient experienced a serious adverse event. Conclusion: Vedolizumab is effective in the achievement of short-term, long-term, and steroid-free clinical remission in bio-naïve UC and CD patients.

Objectives: Although causality remains to be established, targeting dysbiosis of the intestinal microbiota by faecal microbiota transplantation (FMT) has been proposed as a novel treatment for inflammatory diseases. In this exploratory, proof-of-concept study, we evaluated the safety and efficacy of FMT in psoriatic arthritis (PsA). Methods: In this double-blind, parallel-group, placebo-controlled, superiority trial, we randomly allocated (1:1) adults with active peripheral PsA (≥3 swollen joints) despite ongoing treatment with methotrexate to one gastroscopic-guided FMT or sham transplantation into the duodenum. Safety was monitored throughout the trial. The primary efficacy endpoint was the proportion of participants experiencing treatment failure (ie, needing treatment intensification) through 26 weeks. Key secondary endpoints were change in Health Assessment Questionnaire Disability Index (HAQ-DI) and American College of Rheumatology (ACR20) response at week 26. Results: Of 97 screened, 31 (32%) underwent randomisation (15 allocated to FMT) and 30 (97%) completed the 26-week clinical evaluation. No serious adverse events were observed. Treatment failure occurred more frequently in the FMT group than in the sham group (9 (60%) vs 3 (19%); risk ratio, 3.20; 95% CI 1.06 to 9.62; p=0.018). Improvement in HAQ-DI differed between groups (0.07 vs 0.30) by 0.23 points (95% CI 0.02 to 0.44; p=0.031) in favour of sham. There was no difference in the proportion of ACR20 responders between groups (7 of 15 (47%) vs 8 of 16 (50%)). Conclusions: In this first preliminary, interventional randomised controlled trial of FMT in immune-mediated arthritis, we did not observe any serious adverse events. Overall, FMT appeared to be inferior to sham in treating active peripheral PsA. Trial registration number: NCT03058900.

Rhetorical research in the three Scandinavian countries has made contributions to the study of political communication, representing approaches that are not often found in research coming from the social sciences or from more systemic, theory-based orientations. Rhetoric, both as an ancient tradition and as a modern discipline, tends to emphasise close study of actual pieces of communication – verbal, visual, or otherwise. This rarely leads to quantitative, generalisable findings, but instead to observations and conceptualisations of phenomena – which may then be studied from quantitative and empirical angles. Often, rhetorical studies will have a normative tilt, based on notions of democracy, deliberation, and the public sphere – often with an eye for malfunctions and possible remedies. A growing literature of studies in Sweden, Denmark, and Norway tend to share some of these characteristics. At the same time, rhetorical scholars in Scandinavia recognise the value of empirical observation and have made contributions of their own in that regard, for example, in the field of reception studies.

Background: Previously, the diagnosis of irritable bowel syndrome (IBS) required exclusion of organic causes by extensive diagnostic testing. Newer guidelines recommend IBS as a positive diagnosis based on symptoms with limited testing. We investigated the long-term safety and impact on use of health resources of a positive diagnostic strategy compared to a strategy of exclusion in patients with symptoms compatible with IBS. Methods: In 2008-2010, primary care patients aged 18-50 years fulfilling the Rome III criteria for IBS without alarm signals were randomized to a positive diagnostic strategy (limited blood tests, n = 150) or a strategy of exclusion (extensive blood tests, fecal samples for intestinal parasites, and sigmoidoscopy with biopsies, n = 152). At five years, hospital-registered diagnoses and use of health resources including lower endoscopies were retrieved from national registries. Participants provided 5-year data on Rome III criteria for IBS, severity of symptoms, and quality of life. Key results: Baseline mean age was 31.4 (SD 9.1) years; 79% were female. No cases of celiac disease, and gastrointestinal or gynecological cancers were diagnosed within five years. Negligible and comparable numbers were diagnosed with inflammatory bowel disease, benign gynecological conditions, and upper GI conditions in the two groups. The positive diagnosis strategy carried a higher number of lower endoscopies from year 1 to 5 (23 patients versus 13 patients in the exclusion group), but overall saved endoscopies. Conclusions & Inferences: A positive diagnosis of IBS was as safe as a diagnosis of exclusion in a five-year perspective and saved lower endoscopies; the study was registered at ClinicalTrials.gov numbers: NCT00659763/NCT01153295.