Long-Term Safety Following Faecal Microbiota Transplantation as a Treatment for Recurrent Clostridioides difficile Infection Compared with Patients Treated with a Fixed Bacterial Mixture: Results from a Retrospective Cohort Study.

Faecal microbiota transplantation (FMT) is the recommended treatment for recurrent C. difficile infection (rCDI) following a second recurrence. FMT is considered safe in the short term when procedures for the screening of donors and transferred material are followed. However, the long-term safety profile of FMT treatment is largely unknown. In a retrospective cohort study, we assessed the long-term safety of patients treated for rCDI with FMT or a fixed bacterial mixture, rectal bacteriotherapy (RBT). The overall survival, risk of hospital admission, onset of certain pre-specified diseases (cancer, diabetes mellitus, hypertension and inflammatory bowel disease) and risk of being diagnosed with a multidrug-resistant organism were assessed by undertaking a review of the treated patients' medical records for up to five years following treatment. A total of 280 patients were treated for rCDI with FMT (n = 145) or RBT (n = 135) between 2016 and 2020. In the five years following treatment, there were no differences in survival (adjusted hazard ratio (aHR) 1.03; 95% CI 0.68-1.56), p = 0.89), risk of hospital admission ((aHR 0.92; 95% CI 0.72-1.18), p = 0.5) or onset of any of the analysed diseases. In conclusion, FMT was not associated with increased mortality, risk of hospital admission or onset of disease following treatment when compared with RBT.

Successful treatment of Clostridioidesdifficile infection with single-donorfaecal microbiota transplantation capsules.

INTRODUCTION: Treatment of recurrent Clostridioides difficile infection with faecal microbiota transplantation (FMT) is highly effective and is the recommended treatment following a second recurrence. The cure rates of capsule treatment are high (82%-88%). Whether using multi-donor or single-donor FMT capsules affects cure rates remains incompletely understood. METHODS: A retrospective case series of patients with recurrent, refractory or fulminant C. difficile infection treated for three days with single-donor FMT capsules from October to December 2020 was conducted. The aim of the study was to investigate the clinical efficacy (cure rate) of the treatment and to compare cure rates with previously reported cure rates of treatment with multi-donor FMT capsules produced at the same stool bank. Clinical cure was defined as absence of diarrhoea or diarrhoea with a C. difficile negative stool sample eight weeks after treatment. RESULTS: Clinical cure was observed in 15 of the 18 (83.3%) patients following three days of FMT capsule treatment. Cure rates were comparable (p = 1.0) to previously reported cure rates (88.9%) of multi-donor FMT capsule treatment of recurrent C. difficile infection. CONCLUSIONS: Three days of single-donor FMT capsule treatment was effective and safe in the treatment of recurrent, refractory and fulminant C. difficile infection with cure rates comparable to those of multi-donor FMT capsule treatment. FUNDING: This work was supported by the Danish Innovation Fund under Grant 7076-00129B, MICROHEALTH. The funders had no role in the study design, data collection or analysis, the decision to publish, or in the preparation of the manuscript. The FMT capsules from the Aleris-Hamlet FMT Stool Bank were supplied to the Copenhagen University Hospital - Hvidovre Hospital free of charge. TRIAL REGISTRATION: not relevant.

The Efficacy of Faecal Microbiota Transplant and Rectal Bacteriotherapy in Patients with Recurrent Clostridioides difficile Infection: A Retrospective Cohort Study.

The most effective treatment for recurrent Clostridioides difficile infection (CDI) is faecal microbiota transplantation (FMT); however, the optimal route of administration is thus far unknown. This retrospective cohort study of 343 patients sought to evaluate the efficacy of treatment with FMT capsules, FMT enema, and rectal bacteriotherapy (RBT) during a five-year period. The primary endpoint was clinical resolution from CDI after eight weeks, and secondary endpoints were time to recurrence and death during the follow-up period. The proportion of patients with clinical resolution was 79.9% in the FMT capsule group, 53.3% in the FMT enema group, and 61.8% in the RBT group, corresponding to an adjusted odds ratio of 3.79 (CI: 1.82 to 8.26) in the FMT capsule group compared with FMT enema, and 2.92 (CI: 1.49 to 6.03) compared with RBT. The hazards ratio for recurrence within the first 12 months of follow-up was 0.24 (CI: 0.06 to 0.89) in the FMT capsule group compared with FMT enema, and 0.26 (CI: 0.08 to 0.91) compared with RBT. There was no difference in mortality. In conclusion, FMT capsules were more effective than both FMT enema and RBT as treatment of recurrent CDI and reduced the risk of further recurrences.

Waking Up in Pain: a prospective unselected cohort study of pain in 3702 patients immediately after surgery in the Danish Realm.

BACKGROUND: Acute and persistent pain after surgery is well described. However, no large-scale studies on immediate postoperative pain in the operating room (OR) exist, hindering potential areas of research to improve clinical outcomes. Thus, we aimed to describe the occurrence and severity of immediate postoperative pain in a large, unselected cohort. METHODS: This was a prospective cohort study, encompassing all procedures in 31 public hospitals in the Danish Realm, during a 5-day period including the weekend. Data on procedures and anesthesia were collected and the main outcome was occurrence of moderate or severe pain in the OR. Secondary outcomes included pain, sedation and nausea in the OR or during the first 15 min in the postanesthesia care unit (PACU) including relevant risk factors. Descriptive and logistic regression statistics were used. RESULTS: A total of 3675 procedures were included for analysis (87% inclusion rate). Moderate or severe pain occurred in 7.4% (95% CI 6.5% to 8.3%) of cases in the OR immediately after awakening, rising to 20.2% in the OR and/or PACU. Large intraprocedure and interprocedure variations occurred (0.0%-37.5%), and in 20% of cases with epidural-general anesthesia patients experienced moderate or severe pain. Independent risk factors were female sex, younger age, preoperative pain, daily opioid use and major surgical procedures. CONCLUSION: Moderate or severe pain in the immediate postoperative phase occurred in 20% of all cases with procedure and anesthesiological technique variations, suggesting a need for identification of relevant procedure-specific risk factors and development of preventive treatments. TRIAL REGISTRATION NUMBER: RoPR ID 43191.

Fabry disease, respiratory symptoms, and airway limitation - a systematic review.

BACKGROUND: Fabry disease is an X-linked disorder caused by a deficiency of the lysosomal enzyme α-galactosidase A, resulting in accumulation of glycosphingolipids in multiple organs, primarily heart, kidneys, skin, CNS, and lungs. MATERIALS AND METHOD: A systematic literature search was performed using the PubMed database, leading to a total number of 154 hits. Due to language restriction, this number was reduced to 135; 53 papers did not concern Fabry disease, 19 were either animal studies or gene therapy studies, and 36 papers did not have lung involvement in Fabry disease as a topic. The remaining 27 articles were relevant for this review. RESULTS: The current literature concerning lung manifestations describes various respiratory symptoms such as dyspnoea or shortness of breath, wheezing, and dry cough. These symptoms are often related to cardiac involvement in Fabry disease as respiratory examinations are seldom performed. Pulmonary function tests primarily show obstructive airway limitation, but a few articles also report of patients with restrictive limitation and a mixture of both. No significant association has been found between smoking and the development of symptoms or spirometry abnormalities in patients with Fabry disease. Electron microscopy of lung biopsy and induced sputum show lamellar inclusion bodies (Zebra bodies) in the cytoplasm of cells in the airway wall. X-ray and CT scan have shown patchy ground-glass pulmonary infiltrations, fibrosis, and air trapping. Fibrosis diagnosed by high-resolution CT has not been significantly correlated with lung spirometry. CONCLUSION: Consistent findings have not been shown in the current literature. Pulmonary function tests and registration of symptoms showed various results; however, there is a trend towards obstructive airway limitation in patients with Fabry disease. Further studies are needed to evaluate pathogenesis, progression, and the effects of treatment.