The incidence of nosocomial infections, predominantly gastrointestinal and respiratory, in children in developed countries is high, ranging from 5% to 44%. There is no effective strategy for ...preventing these infections. The objective of our study was to investigate the role of Lactobacillus GG (LGG) in preventing nosocomial gastrointestinal and respiratory tract infections at a pediatric hospital.
We conducted a randomized, double-blind, placebo-controlled trial of 742 hospitalized children. They were randomly allocated to receive for their hospitalization LGG at a dose of 10(9) colony-forming units in 100 mL of a fermented milk product (LGG group, n = 376) or placebo that was the same postpasteurized fermented milk product without LGG (placebo group, n = 366).
In the LGG group, compared with the placebo group, we found a significantly reduced risk for gastrointestinal infections (relative risk RR: 0.40 95% confidence interval (CI): 0.25-0.70; number needed to treat: 15 95% CI: 9-34), respiratory tract infections (RR: 0.38 95% CI: 0.18-0.85; number needed to treat: 30 95% CI: 16-159), vomiting episodes (RR: 0.5 95% CI: 0.3-0.9), diarrheal episodes (RR: 0.24 95% CI: 0.10-0.50), episodes of gastrointestinal infections that lasted >2 days (RR: 0.40 95% CI: 0.25-0.70), and episodes of respiratory tract infections that lasted >3 days (RR: 0.4 95% CI: 0.2-0.9). Groups did not differ in hospitalization duration (P = .1).
LGG administration can be recommended as a valid measure for decreasing the risk for nosocomial gastrointestinal and respiratory tract infections in pediatric facilities.
Maintenance treatment with vedolizumab, a monoclonal antibody that inhibits the gut-selective α4β7 integrin, is administered intravenously. Some patients might prefer a subcutaneous formulation of ...vedolizumab for maintenance treatment. Subcutaneous vedolizumab was investigated as maintenance treatment in patients with moderately to severely active ulcerative colitis.
We performed a phase 3, double-blind, double-dummy trial at 141 sites in 29 countries from December 18, 2015 through August 21, 2018. Patients with moderately to severely active ulcerative colitis received open-label treatment with intravenous vedolizumab 300 mg at weeks 0 and 2. At week 6, patients with clinical response were randomly assigned maintenance treatment with subcutaneous vedolizumab 108 mg every 2 weeks, intravenous vedolizumab 300 mg every 8 weeks, or placebo. The primary end point was clinical remission at week 52, which was defined as a total Mayo score of ≤2 and no subscore >1.
Among the randomized 216 patients, clinical remission at week 52 was achieved by 46.2%, 42.6%, and 14.3% of patients in the subcutaneous vedolizumab, intravenous vedolizumab, and placebo groups, respectively (subcutaneous vedolizumab vs placebo: Δ32.3%; 95% confidence interval, 19.7%–45.0%; P < .001). The subcutaneous vedolizumab group also had greater endoscopic improvement and durable clinical response at week 52 compared with placebo (both P < .001). The incidence of injection-site reactions was more frequent in patients given subcutaneous vedolizumab (10.4%) than intravenous vedolizumab (1.9%) or placebo (0%); these were not treatment limiting, most were mild, and none resulted in discontinuation. Subcutaneous and intravenous vedolizumab safety profiles were otherwise similar.
Subcutaneous vedolizumab is effective as maintenance therapy in patients with moderately to severely active ulcerative colitis who had a clinical response to intravenous vedolizumab induction therapy. It has a favorable safety and tolerability profile. ClinicalTrials.gov ID: NCT02611830; EudraCT 2015-000480-14.
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Faecal calprotectin is an important biomarker used in the evaluation of inflammatory bowel disease. The aim of this study was to establish the value of faecal calprotectin concentration as a ...predictor of remission in ulcerative colitis and its correlation with laboratory, endoscopic and clinical findings.
The single centre study included 126 adult patients with established diagnosis of ulcerative colitis consecutively visiting our Day clinic from March 2017 to March 2019. We measured serum biomarkers- CRP, haemoglobin, leukocytes and platelets. Faecal calprotectin was determined from stool, and endoscopy was performed with calculation of MAYO endoscopic subscore system (MES 0-1: remission, and MES 2-3: active disease). Clinical assessment was done by using Mayo score for ulcerative colitis (clinical Mayo score <2:remission, >5: active disease).The statistical analysis was performed using an univariate and multivariate model of disease remission prediction using logistic regression.
According to univariate analysis the increase of faecal calprotectin concentration by 10 ug/g is associated with an 8% decrease in probability of disease remission (OR 0.9921, p < .05). In the multivariate analysis, faecal calprotectin remained a significant predictor of disease remission (OR 0.9948, 95% CI 0.9914-0.9982, p = .0028), however, with a significant contribution of C-reactive protein (OR 0.8340, 95% CI 0.7085-0.9818, p = .0292). According to our model the cut off value for faecal calprotectin was 154 ug/g.
Our results have shown that faecal calprotectin is an independent predictor of remission in UC patients. The results of our study represent real-life data from a single university centre dealing with FC as a prognostic marker in patients with UC.
KEY MESSAGES
Faecal calprotectin is an independent predictor of remission in UC patients.
Recent studies have suggested that calprotectin correlates well with endoscopic activity of inflammation but correlation of faecal calprotectin in a phase of remission hasn't been evaluated yet.
We have found that other inflammatory biomarkers do not correlate well with either endoscopic or clinical activity in ulcerative colitis.
Challenging periods like the COVID-19 pandemic require fast and efficient adaptations of the healthcare system. It is vital that every patient has access to nutritional care as a part of primary ...healthcare services, even if social distancing measures are adopted. Therefore, we propose a simple remote nutritional screening tool and practical guidance for nutritional care in primary practice, and their implementation into telemedicine processes and digital platforms suitable for healthcare providers. The acronym for the tool is R-MAPP, as for Remote – Malnutrition APP, while the tool will be available also as an app. This protocol consists of two simple validated clinical tools for identifying nutritional risk and loss of muscle mass and function –Malnutrition Universal Screening Tool (‘MUST’) and SARC-F (5-item questionnaire: Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls) - and additional practical guidance on nutritional interventions for family physicians.
The Mediterranean diet (MD) and the Nordic diet (ND) share more similarities than differences. Both diets are based on typical local and seasonal foods, share similar nutritional recommendations ...based on plant-based dietary principles, and are both now orienting toward environmental protection and sustainability. The main difference between the two diets is the primary fat source. Olive oil is the synonym for MD while the ND uses more rapeseed/canola oil. While longitudinal epidemiological studies support adherence to MD as a way to prevent chronic diseases, ND still needs more such studies because the current results are discrepant. Notably, studies that assessed the association between both diets and lower risks of chronic diseases, disability, and mortality from specific and all causes, implied that ND could also have an advantageous effect as MD. Hopefully, there will be more longitudinal and large prospective studies in the future that will provide more evidence-based recommendations.
In 2016, ESPEN published the guideline for Chronic Intestinal Failure (CIF) in adults. An updated version of ESPEN guidelines on CIF due to benign disease in adults was devised in order to ...incorporate new evidence since the publication of the previous ESPEN guidelines.
The grading system of the Scottish Intercollegiate Guidelines Network (SIGN) was used to grade the literature. Recommendations were graded according to the levels of evidence available as A (strong), B (conditional), 0 (weak) and Good practice points (GPP). The recommendations of the 2016 guideline (graded using the GRADE system) which were still valid, because no studies supporting an update were retrieved, were reworded and re-graded accordingly.
The recommendations of the 2016 guideline were reviewed, particularly focusing on definitions, and new chapters were included to devise recommendations on IF centers, chronic enterocutaneous fistulas, costs of IF, caring for CIF patients during pregnancy, transition of patients from pediatric to adult centers. The new guideline consist of 149 recommendations and 16 statements which were voted for consensus by ESPEN members, online in July 2022 and at conference during the annual Congress in September 2022. The Grade of recommendation is GPP for 96 (64.4%) of the recommendations, 0 for 29 (19.5%), B for 19 (12.7%), and A for only five (3.4%). The grade of consensus is “strong consensus” for 148 (99.3%) and “consensus” for one (0.7%) recommendation. The grade of consensus for the statements is “strong consensus” for 14 (87.5%) and “consensus” for two (12.5%).
It is confirmed that CIF management requires complex technologies, multidisciplinary and multiprofessional activity, and expertise to care for the underlying gastrointestinal disease and to provide HPN support. Most of the recommendations were graded as GPP, but almost all received a strong consensus.
In this cross-sectional study, our aim was to analyze association of ambulatory blood pressure monitoring (ABPM) values with pulse wave velocity (PWV) in inflammatory bowel disease (IBD) patients as ...well as the prevalence and characteristics of white coat hypertension (WCH) in this group of patients with chronic inflammation and high prevalence of anxiety. We enrolled 120 consecutive IBD patients (77 Crohn´s disease; 43 ulcerative colitis) who were not treated with antihypertensive drugs without cardiovascular, cerebrovascular and renal morbidity. Office blood pressure, ABPM, and PWV were measured with Omrom M6, SpaceLab 90207, and Arteriograph, respectively. The prevalence of true normotension, sustained hypertension and WCH was analyzed in IBD patients. WCH was found in 27.5% patients. IBD-WCH patients had significantly lower prevalence of traditional risk factors than general WCH subjects. PWV and augmentation index (AIx) values were higher in WCH than in true normotensive patients. When adjusted for age and duration of IBD, only PWV was a positive predictor of WCH, and patients with higher PWV and longer disease duration had OR´s for WCH of 0.69 and 2.50, respectively. IBD patients had significantly higher prevalence of WCH and higher PWV values than healthy control patients. WCH is highly prevalent in IBD patients but IBD-WCH patients have lower frequency of traditional cardiovascular risk factors than general WCH population. Our results suggest that WCH could be considered as another clinical characteristic of IBD which is associated with increased arterial stiffness and those patients should be monitored more closely.
Etrasimod, a novel selective sphingosine-1-phosphate receptor modulator, was recently approved by the U.S. Food and Drug Administration and the European Medicinal Agency for the treatment of ...moderately to severely active ulcerative colitis in adults. In this research, the forced degradation study as an integral part of drug product and packaging development, which generates data on degradation mechanisms, is published. The development and validation of the stability-indicating method using a superior high-performance liquid chromatography technique coupled with a diode array detector and tandem mass spectrometer was performed to support the forced degradation study and monitor the formation of degradation products. Etrasimod demonstrated good stability under elevated temperature and basic stress conditions, while acidic hydrolysis, oxidative, and photolytic degradation produced eight degradation products. The knowledge of degradation products will be useful in the long-term stability study for establishing the acceptance criteria of etrasimod as a drug substance and dosage form during quality control and stability assessment. The eco-friendliness of the developed forced degradation procedure was evaluated using various greenness appraisal tools. The green metric tools showed that the forced degradation procedure obeys eco-friendly conditions.
•Development of stability-indicating method for etrasimod by HPLC/DAD/MS/MS.•Etrasimod demonstrated stability under elevated temperature and basic hydrolysis.•The stress conditions produced eight degradation products of etrasimod.•The eco-friendliness of the procedure was evaluated using 4 greenness appraisal tools.
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