Background: Protocols for treating recurrent Clostridium difficile infection (rCDI) through faecal microbiota transplantation (FMT) are still not standardised. Our aim was to evaluate the efficacy of different FMT protocols for rCDI according to routes, number of infusions and infused material. Methods: MEDLINE, Embase, SCOPUS, Web of Science and the Cochrane Library were searched through 31 May 2017. Studies offering multiple infusions if a single infusion failed to cure rCDI were included. Data were combined through a random effects meta-analysis. Results: Fifteen studies (1150 subjects) were analysed. Multiple infusions increased efficacy rates overall (76% versus 93%) and in each route of delivery (duodenal delivery: 73% with single infusion versus 81% with multiple infusions; capsule: 80% versus 92%; colonoscopy: 78% versus 98% and enema: 56% versus 92%). Duodenal delivery and colonoscopy were associated, respectively, with lower efficacy rates (p ¼ 0.039) and higher efficacy rates (p ¼ 0.006) overall. Faecal amount 50 g (p ¼ 0.006) and enema (p ¼ 0.019) were associated with lower efficacy rates after a single infusion. The use of fresh or frozen faeces did not influence outcomes. Conclusions: Routes, number of infusions and faecal dosage may influence efficacy rates of FMT for rCDI. These findings could help to optimise FMT protocols in clinical practice. Key summary. Faecal microbiota transplantation (FMT) is highly effective against recurrent Clostridium difficile infection (rCDI). . However, there is still no clear evidence supporting the superiority of one working protocol over another.. Routes of delivery, number of infusions and faecal dosage may influence efficacy of FMT for rCDI. . These findings may be useful to optimise FMT protocols in clinical practice.

Background No data on the recently introduced infliximab (IFX) biosimilar SB2 in inflammatory bowel disease (IBD) are available. Methods The Sicilian Prospective Observational Study of Patients With IBD Treated With Infliximab Biosimilar SB2 is a multicenter, observational, prospective study performed among the cohort of the Sicilian Network for Inflammatory Bowel Disease. All consecutive IBD patients starting the IFX biosimilar SB2 from its introduction in Sicily (March 2018) to September 2019 (18 months) were enrolled. Results Two hundred seventy-six patients (Crohn disease: 49.3%, ulcerative colitis: 50.7%) were included: 127 (46.0%) were naïve to IFX and naïve to anti-tumor necrosis factor medications (anti-TNFs), 65 (23.5%) were naïve to IFX and previously exposed to anti-TNFs, 17 (6.2%) were switched from an IFX originator to SB2, 43 (15.6%) were switched from the biosimilar CT-P13 to SB2, and 24 (8.7%) were multiply switched (from IFX originator to CT-P13 to SB2). The cumulative number of infusions of SB2 was 1798, and the total follow-up time was 182.7 patient-years. Sixty-seven serious adverse events occurred in 57 patients (20.7%; incidence rate: 36.7 per 100 patient-year), and 31 of these events caused the withdrawal of the drug. The effectiveness after 8 weeks of treatment was evaluated in patients naïve to IFX (n = 192): 110 patients (57.3%) had steroid-free remission, while 56 patients had no response (29.2%). At the end of follow-up, 72 patients (26.1%) interrupted the treatment, without significant differences in treatment persistency estimations between the five groups (log-rank P = 0.15). Conclusions The safety and effectiveness of SB2 seem to be overall similar to those reported for the IFX originator and CT-P13.

Background Biologically naïve patients with inflammatory bowel disease treated with vedolizumab (VDZ) are largely underrepresented in real-world cohorts. A multi-centre, observational cohort study was performed on the effectiveness and safety of VDZ in biologically naïve subjects with Crohn’s disease (CD) and ulcerative colitis (UC). Methods Data of consecutive biologically naïve patients with CD and UC treated with VDZ from July 2016 to December 2019 were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease. Results A total of 172 consecutive patients (CD: N = 88; UC: N = 84; median age 66.0 years) were included, with a median follow-up of 58.8 weeks. After 14 weeks, a clinical response was reported in 68.2% of patients with CD and 67.9% of patients with UC treated with VDZ, including 45.5% patients in the CD group and 46.4% patients in the UC group who achieved steroid-free remission. After 52 weeks, a clinical response was reported in 77.4% of CD and in 73.8% of UC patients treated with VDZ, including 59.7% patients in the CD group and 60.7% patients in the UC group who achieved steroid-free remission. Conclusions This study demonstrates the effectiveness and safety of VDZ as a first-line biological, particularly among elderly patients.

Purpose: Bioimpedance data through bioimpedance vector analysis (BIVA) is used to evaluate cellular function and body fluid content. This study aimed to (i) identify whether BIVA patters differ according to the competitive period and (ii) provide specific references for assessing bioelectric properties at the start of the season in male elite soccer players. Methods: The study included 131 male soccer players (age: 25.1 ± 4.7 yr, height: 183.4 ± 6.1 cm, weight: 79.3 ± 6.6) registered in the first Italian soccer division (Serie A). Bioimpedance analysis was performed just before the start of the competitive season and BIVA was applied. In order to verify the need for period-specific references, bioelectrical values measured at the start of the season were compared to the reference values for the male elite soccer player population. Results: The results of the two-sample Hotelling T2 tests showed that in the bivariate interpretation of the raw bioimpedance parameters (resistance (R) and reactance (Xc)) the bioelectric properties significantly (T2 = 15.3, F = 7.6, p ≤ 0.001, Mahalanobis D = 0.45) differ between the two phases of the competition analyzed. In particular, the mean impedance vector is more displaced to the left into the R-Xc graph at the beginning of the season than in the first half of the championship. Conclusions: For an accurate evaluation of body composition and cellular health, the tolerance ellipses displayed by BIVA approach into the R-Xc graph must be period-specific. This study provides new specific tolerance ellipses (R/H: 246 ± 32.1, Xc/H: 34.3 ± 5.1, r: 0.7) for performing BIVA at the beginning of the competitive season in male elite soccer players.

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