Abstract Background Short bowel syndrome(SBS)is a severe clinical condition occuring when,following multiple intestinal resections,the remaining small bowel in continuity is ≤200cm.SBS is associated with intestinal failure(IF)when the intestinal absorptive function is compromised,requiring intravenous nutritional or electrolyte supplementation.Crohn’s disease(CD)is one of adults’ most frequent causes of SBS.The aim of this study was to identify clinical predictive factors of SBS in CD pts Methods We performed a prospective study, enrolling consecutive CD outpatients (pts).Statistical univariate comparison for primary outcome was assessed for continuous variables by the Mann-Whitney U test and the Kruskal-Wallis ANOVA test.Categorical variables were compared using the chi-square test.We also assessed a multivariate logistic regression model to identify independent predictors of SBS Results We enrolled 169 CD pts(47.3% male,mean age 43.5 years[±14.1]).45.5% of them were smokers;extraintestinal manifestations(EIMs)were present in 45.5% of pts, and 67.5% of pts had bowel resections(26.6% of them with more than one surgical intervention).Median disease duration and median time between diagnosis and the first resection were 9y(IQR 4-17)and 6.5y(IQR 1-13),respectively.At baseline,101 pts were on anti-TNF therapy,and considering the course of the disease,overall,20.1% of the pts were exposed to ≥3 biologics.10% of pts had SBS and 5.3% IF.In univariate analysis,comparing patients with and without SBS,the following variables were statistically different:disease duration(p=0.000),upper gastrointestinal disease location(p=0.001),ileocolonic location(p=0.008),stenosing behavior(p=0.040),perianal disease(p=0.000)and time elapsing from CD diagnosis to start biological therapy(0.002).At multivariate analysis,disease duration(p=0.000),perianal disease(p=0.05)and time elapsing from CD diagnosis to start biological therapy(p=0.016)resulted independently associated with the development of SBS Conclusion Our data identify the clinical features that would allow the gastroenterologists to predict the risk of developing SBS in a cohort of CD pts.Further studies would be needed to confirm our findings.Funded by:2.1 “Rafforzamento e potenziamento della ricerca biomedica del SSN”,finanziato dall’Unione europea–NextGenerationEU, CUP C53C22001140007. 2022 PNRR Project “Changing the future of intestinal failure in intestinal chronic inflammation:towards innovative predictive factors and therapeutic targets”code:PNRR-MAD-2022-12376791

Abstract Background Crohn's disease (CD) is a leading cause of short bowel syndrome (SBS) in adults, which can result in intestinal failure (IF) when intravenous nutritional or electrolyte supplementation is required. SBS is frequently associated with sarcopenia, characterized by loss of muscle mass and function, which adversely impacts quality of life and increases the risk of complications. This study aimed to evaluate differences in body composition and muscle strength among CD patients at varying risk levels for SBS. Methods We conducted a cross-sectional study involving consecutive CD outpatients. The participants were divided into two groups. Group A consisted of CD patients diagnosed with SBS and patients who had undergone two or more bowel resections, or a resection of more than 50 cm. Group B included patients who had never undergone surgery or those who had undergone a resection of less than 50 cm. Body composition was assessed using bioimpedance analysis (BIA), and muscle strength was measured via hand grip testing with a dynamometer, recording the best result of three attempts with the dominant hand. We administered food frequency questionnaire (FFQ) to assess eating habits. Statistical analyses, including t-tests or Mann-Whitney tests, were used as appropriate, with a significance threshold of p < 0.05. Results The study cohort included 150 patients (mean age 53 years [±19,2]; 24% female). Group A showed an average BMI of 23,7±4 kg/m2, whereas group B showed an average BMI of 24.6±5 kg/m2. Muscle strength measured between groups was reduced in group A showing significant differences in hand grip test compared to group B (p-value<0.001). However, no significant differences were observed in BIA parameters, including muscle mass, or in eating habits across the groups. Conclusion Our study revealed that SBS patients and CD patients resected two or more times or with a resection greater than 50 cm had reduced muscle strength without a corresponding reduction in muscle mass, indicating impaired muscle function. Further research is needed to better understand the relationship between Crohn's disease-related resections and their impact on both muscle quality and quantity. Funded by:2.1 "Rafforzamento e potenziamento della ricerca biomedica del SSN",finanziato dall’Unione europea–NextGenerationEU, CUP C53C22001140007. 2022 PNRR Project "Changing the future of intestinal failure in intestinal chronic inflammation:towards innovative predictive factors and therapeutic targets"code:PNRR-MAD-2022-12376791

Abstract Background Limited evidence is available about predictors of response to specific medications for ulcerative colitis (UC). OCTN1, an organic cation transporter, with its variants, could modulate the inflammatory response and potentially modify drug response to immune-modulatory therapy (anti-TNFα and vedolizumab), perhaps predicting individual response. Methods We first confirmed the ability of OCTN1 to differentially modulate IL1β secretion under different stimuli in a human leukemia monocytic cell line (THP-1) and in human peripheral blood mononuclear cells. We therefore prospectively enrolled a cohort of UC patients starting either anti-TNFα or vedolizumab, determined their OCTN1 genotype and evaluated their clinical features at baseline and clinical response to therapy or disease remission (according to clinical Mayo score) after six weeks (T1) and six months (T2). We finally enrolled a cohort of UC patients in clinical and endoscopic remission (according to full Mayo score) under immune-modulatory therapy (anti-TNFα or vedolizumab) for at least two years. Results OCTN1-deficient THP1 cells showed reduced IL-1β secretion in response to peptidoglycan (PGN) and Fusobacterium nucleatum (Fn), whilst primary monocytes bearing OCTN1 503F variant displayed an increased production of IL-1β in response to PGN and live bacteria. We therefore enrolled 90 patients, 50 starting anti-TNFα and 40 vedolizumab. Patients with 503F genotype showed higher rates of pancolitis as compared to 503L genotype. Among patients with 503L genotype, vedolizumab results highly associated with long-term response (OR 8.92, 95%CI 0.50-11.0; p=0.019), whilst conversely co-presence of 503F genotype and vedolizumab therapy disclosed an opposite role on the long-term response rate (OR 0.02, 95%CI 0.00-0.81; p=0.038).The population of UC patients in clinical and endoscopic remission was composed by 92 patients, 63 under anti-TNFα and 29 under vedolizumab. Of note, similar trends of disease extension were observed across genotypes: higher rates of pancolitis were observed in the 503F population as compared to 503L (62.5% vs 44%). Furthermore, among patients in remission with 503F genotype, the percentage of subjects receiving vedolizumab was sensibly lower than among patients with 503L genotype (87.5% anti-TNFα vs12.5% vedolizumab among 503F genotype; 56% anti-TNFα vs 44% vedolizumab among 503L genotype). Conclusion Mutated OCTN1 genotype (503F) favors an increased IL1β secretion from human stimulated leukocytes, thus suggesting a worse disease course with higher rate of pancolitis and lower response to vedolizumab as compared to 503L.

Abstract Background Self-care is an active process to maintain and promote health in chronic disease situations, and is effective in the results of many chronic diseases. So far, few studies have been conducted on the self-care of IBD. The study of self-care in IBD is also motivate, by the increase in prevalence in the coming years and the impact on health resources it could have. In addition, the study of self-care in relation to socio-sanitary features and habits within the population affected by IBD may be the beginning to identify areas for educational interventions by health care personnel. The primary objective of this study is to describe the levels of self-care maintenance, monitoring and management in patients with IBD. Methods Cross-sectional observational study to evaluate self-care in IBD patient. The questionnaire used was the Self-Care of Chronic Disease Index (SCCII). The SCCII investigates three aspects of self-care, maintenance, monitoring and management and the self-efficacy. The sociodemographic characteristics and some patient habits such as smoking habit, fatigue, exercise, sleep, nutrition and supplement use, were investigated. Ethics Committee approved Results We enrolled 85 patients with an average age of 44.8±16.8, of which 51.8% (female) and 50.6% (CD), 48.4% (UC). The level of self-care (SCCII) areas investigated ranged from score levels of 71.30 (Self-maintenance), 79.52 (self-monitoring), 68.94 (self-management) and 75.70 (self-efficacy). In the area of self-care maintenance the aspects that seem least considered by patients (never or rarely) are stress management (44.1%) and exercise (40%). Only 57.6% of patients often or always get enough sleep and only 22.3% of patients follow a healthy diet. The presence of fatigue seems to affect 68% of patients in the self-monitoring phase. In the area of self-management, only 41.2% of patients (often or always) try to rest during the day and only 52% of the sample succeeds continuously with the appearance of symptoms. In self-efficacy, it seems that 85.8% of the patients interviewed persist in following the treatment even when it is difficult. It seems that men have more significant levels of self-maintenance score 74. vs 68.8 (p>0.01) than women. Table 1 shows the average self-care scores in relation to the habits investigated. Conclusion From the results of our study it seems that patients with IBD have adequate levels of self-care (score ≥70), although sleep/rest, diet and exercise seem not to be highly considered by patients. Future studies may investigate which specific sociodemographic and clinical characteristics can be identified as predictors of maintaining self-care, self-care management and self-confidence, to improve areas of nurse educational intervention.

Abstract Background Inflammatory Bowel Diseases (IBD) are multifactorial diseases including Ulcerative Colitis (UC) and Crohn's Disease (CD). Up to 50% of IBD patients show a primary or secondary non-response to standard biological therapy. Hence, Randomized Clinical Trials (RCTs) represent a significant therapeutic opportunity for them. This study aims to describe the clinical characteristics of "trial IBD patients" vs. "real-life IBD". Methods We prospectively enrolled patients who started biologic therapy from August 2019 to August 2020. We divided patients into 3 sub-groups: (1) "real-life", patients treated according to clinical practice with biologic therapy that did not meet the inclusion and exclusion criteria for RCTs, (2) "real-life suitable for trial", patients potentially eligible in RCTs, but treated with standard of care, and (3) "trial", patients treated with drugs from 14 phases 2b and 3 studies actively recruiting in our center. Results We enrolled 134 patients (72 UC, 62 CD). "Real-life" patients were 41 in UC and 38 in CD, "real-life suitable for trial" were 6 in UC and 14 in CD, and "trial" were 25 in UC and 10 in CD. According to the existing inclusion and exclusion criteria, the study showed that 43% UC patients and 39% CD were suitable for enrollment in RCTs, however only 16% of CD were finally enrolled in RCTs. At the enrollment, patients were mainly excluded for topical therapy use, cancer, recent infections, low CDAI (<220) or SED-CD (<6), or presence of complication of diseases in CD or for limited extension of disease in UC. Both "trial" UC and CD patients presented more extraintestinal manifestations of disease, especially the articular ones (p<0,05) and a higher significant concomitant use of systemic corticosteroids (≤20mg/die (p < 0,05)). Percentages of patients treated previously with other biological drugs were superior in "trial" patients compared to "real-life" only in UC (88% vs 29%). We observed different baseline clinical disease activity scores in CD: the HBI of "real-life" patients was 4.8, and the HBI of "trial" patients was 9.1. In addition, patients enrolled in RCTs waited longer before accessing the proposed biological therapy. Conclusion This study highlights some differences between clinical practice and RCTs, particularly regarding criteria to start biologic therapy. Globally "trial patients" have more complex diseases that significantly impact their clinical status. Furthermore, RCTs use clinical scores (e.g. CDAI) as determinants for enrollment and decision-making, while endoscopy and radiological imaging are more widely used in clinical practice for decision making. These differences could cover the actual effectiveness of a new drug compared to the theoretical efficacy deriving from registration RCTs.

Abstract Background Inflammatory Bowel Disease (IBD) management requires a multidisciplinary team, in which nurses have a pivotal role. Although patient care is the main focus of all clinical actions, satisfaction with healthcare professionals is an aspect of growing importance that has been related to positive clinical outcomes. In this setting, evaluating the satisfaction of the nursing provided could be a pivotal component for the satisfaction of the patient, particularly in the IBD unit, where patients in intravenous (iv) biological therapy spend a major amount of time compared to non-complicated acute hospitalization. The aim of the study is to measure the overall quality of nursing care perceived by IBD patients receiving biological therapy. Furthermore, the opinion of loyal and non-loyal patients was measured at the IBD center as a secondary objective Methods Cross-sectional observational study to assess nursing satisfaction through the Newcastel Satisfaction Nursing Scale (NSNS). The instrument consists of two separate scales: the Scale of Nursing Care Experiences ("A") and the Scale of Nursing Satisfaction ("B"). The patient who is followed by the center, at the time of administering the questionnaire, for a period of more than 12 months, will be considered in the arm long follow-up while all patients treated at the center for a period ranging from 0 to 12 months, in those short follow-up. The study protocol was approved by the Ethics Committee. Results Two hundred and thirty-four in biological therapy, questionnaires were administered, of these, with an excellent response rate, 200 (86.2%). The result was an overall level of satisfaction compared to the first scale "A", equal to 88.4%, while for the second scale "B" the total result was 90.7%. By analyzing the satisfaction of nursing care received, differentiating the patient between short and long follow-up, the results seem to confirm how the patient in the long follow-up positively affects satisfaction, significantly in the first scale "A" 90.5% vs 82.9% p = 0.0002 and in the second scale "B" 92.5% vs 86% p = 0.0001. The lowest average satisfaction scores were recorded in the doctor-nurse ratio and in the communicative aspects, while the highest scores are related to the empathic components and professional competence of nursing. Conclusion In conclusion, the level of satisfaction of patients in biological therapy is high and this seems to increase significantly with time and with patient loyalty to the center (Fig. 1). Further research projects could aim to fill gaps in knowledge and validate scales of assessment of nursing skills in the field of IBD, including by structuring studies with a control cohort.

OBJECTIVEThe role of nurses has great educational-scientific potential in COVID-19 vaccination. The aim of this work is to clarify whether the educational role of IBD nurses in vaccination is perceived by IBD patients.MATERIALS AND METHODSA cross-sectional study was carried out, through a questionnaire, to evaluate how many IBD patients received health education about vaccinations from the dedicated nurses (IBD nurses).RESULTSThere were four hundred questionnaires, 310 patients (77.5%) answered all questions. The nurse does not appear to help educate patients on influenza vaccination (66.1%) or pneumococcal vaccination (81.6%). Disclosed patients have many doubts about the new COVID-19 vaccination (74.4%) and many seek information (74.8%) and think that the nurse can provide the necessary information (70%).CONCLUSIONSIBD nurses do not seem very active in the vaccination education role, and they do not meet patients' expectations, which are conversely very high.