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Summary Background Cure rates for eradication of Helicobacter pylori appear to be decreasing, thus more effective therapies must be identified. Aim To evaluate the efficacy of bovine lactoferrin in the treatment of H. pylori infection. Methods In a multicentred prospective study, 402 (mean age 52.4, range 19–84 years) H. pylori-positive patients were assigned to one of three regimens: group A – esomeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. for 7 days; group B – lactoferrin 200 mg b.d. for 7 days followed by the same schedule of group A; group C – esomeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. plus lactoferrin 200 mg b.d. for 7 days. Results Of the 402 patients, 389 completed the study. Six patients were discontinued due to side effects, one patient in group B died and six patients were lost to follow up. The eradication rate (intention-to-treat analysis) was 77% in group A (105/136), 73% in group B (97/132) and 90% in group C (120/134) (χ2-test P

We sought (i) to validate a new prediction rule of mortality (Progetto Nazionale Emorragia Digestiva (PNED) score) on an independent population with non-variceal upper gastrointestinal bleeding (UGIB) and (ii) to compare the accuracy of the Italian PNED score vs. the Rockall score in predicting the risk of death.We conducted prospective validation of analysis of consecutive patients with UGIB at 21 hospitals from 2007 to 2008. Outcome measure was 30-day mortality. All the variables used to calculate the Rockall score as well as those identified in the Italian predictive model were considered. Calibration of the model was tested using the chi2 goodness-of-fit and performance characteristics with receiver operating characteristic (ROC) analysis. The area under the ROC curve (AUC) was used to quantify the diagnostic accuracy of the two predictive models.Over a 16-month period, data on 1,360 patients were entered in a national database and analyzed. Peptic ulcer bleeding was recorded in 60.7% of cases. One or more comorbidities were present in 66% of patients. Endoscopic treatment was delivered in all high-risk patients followed by high-dose intravenous proton pump inhibitor in 95% of them. Sixty-six patients died (mortality 4.85%; 3.54-5.75). The PNED score showed a high discriminant capability and was significantly superior to the Rockall score in predicting the risk of death (AUC 0.81 (0.72-0.90) vs. 0.66 (0.60-0.72), P0.000). Positive likelihood ratio for mortality in patients with a PNED risk score8 was 16.05.The Italian 10-point score for the prediction of death was successfully validated in this independent population of patients with non-variceal gastrointestinal bleeding. The PNED score is accurate and superior to the Rockall score. Further external validation at the international level is needed.

Abstract Studies so far conducted on irritable bowel syndrome (IBS) have been focused mainly on the role of gut bacterial dysbiosis in modulating the intestinal permeability, inflammation, and motility, with consequences on the quality of life. Limited evidences showed a potential involvement of gut fungal communities. Here, the gut bacterial and fungal microbiota of a cohort of IBS patients have been characterized and compared with that of healthy subjects (HS). The IBS microbial community structure differed significantly compared to HS. In particular, we observed an enrichment of bacterial taxa involved in gut inflammation, such as Enterobacteriaceae, Streptococcus, Fusobacteria, Gemella, and Rothia, as well as depletion of health-promoting bacterial genera, such as Roseburia and Faecalibacterium. Gut microbial profiles in IBS patients differed also in accordance with constipation. Sequence analysis of the gut mycobiota showed enrichment of Saccharomycetes in IBS. Culturomics analysis of fungal isolates from feces showed enrichment of Candida spp. displaying from IBS a clonal expansion and a distinct genotypic profiles and different phenotypical features when compared to HS of Candida albicans isolates. Alongside the well-characterized gut bacterial dysbiosis in IBS, this study shed light on a yet poorly explored fungal component of the intestinal ecosystem, the gut mycobiota. Our results showed a differential fungal community in IBS compared to HS, suggesting potential for new insights on the involvement of the gut mycobiota in IBS. Key points • Comparison of gut microbiota and mycobiota between IBS and healthy subjects • Investigation of cultivable fungi in IBS and healthy subjects • Candida albicans isolates result more virulent in IBS subjects compared to healthy subjects

Background Inpatients are at risk for inadequate colon cleansing. Experts recommend 4L-polyethylene-glycol (PEG) solution. A higher colon cleansing adequacy rate for a hyperosmolar 1L-PEG plus ascorbate prep has been recently reported. Aims We aimed to determine whether 1L-PEG outperforms 4L-PEG among inpatients. Methods post-hoc analysis of a large Italian multicenter prospective observational study among inpatients (QIPS study). We performed a propensity score matching between 1L-PEG and 4L-PEG group. The primary outcome was the rate of adequate colon cleansing as assessed by unblinded endoscopists through Boston scale. Secondary outcome was the safety profile. Results Among 1,004 patients undergoing colonoscopy, 724 (72%) were prescribed 4L-PEG and 280 (28%) 1L-PEG. The overall adequate colon cleansing rate was 69.2% (n = 695). We matched 274 pairs of patients with similar distribution of confounders. The rate of patients with adequate colon cleansing was higher in 1L-PEG than in 4L-PEG group (84.3% vs. 77.4%, p = 0.039). No different shift in serum concentration of electrolytes (namely Na+, K+, Ca2+), creatinine and hematocrit were observed for both preparations. Conclusion We found a higher rate of adequate colon cleansing for colonoscopy with the 1L-PEG bowel prep vs. 4L-PEG, with apparent similar safety profile, among inpatients. A confirmatory randomized trial is needed. (ClinicalTrials.gov no: NCT04310332)

Background Colonoscopy demands a considerable amount of resources, and little is known about its diagnostic yield among inpatients. Aims To assess indications, diagnostic yield and findings of colonoscopy for inpatients, and to identify risk factors for relevant findings and cancer. Methods Multicentre, prospective, observational study including 12 hospitals. Consecutive adult inpatients undergoing colonoscopy were evaluated from February through November 2019. Results 1,302 inpatients underwent colonoscopy. Diagnostic yield for relevant findings and cancer was 586 (45%) and 112 (8.6%), respectively. Adequate colon cleansing was achieved in 896 (68.8%) patients. Split-dose/same-day regimen was adopted in 847 (65%) patients. Factors associated to relevant findings were age ≥70 years (RR 1.32), male gender (RR 1.11), blood loss (RR 1.22) and adequate cleansing (RR 1.63). Age ≥70 years (RR 2.08), no previous colonoscopy (RR 2.69) and split-dose/same-day regimen (RR 1.59) significantly increased cancer detection. Implementing adequate cleansing and split-dose/same-day regimen in all patients would increase the diagnostic yield for any relevant findings and cancer from 43% to 70% and from 6% to 10%, respectively. Conclusion Relevant colorectal diseases and cancer were frequent among inpatients. Factors associated with detection of relevant findings were identified. Adequate colon cleansing and split-dose/same-day regimen significantly increased colonoscopy diagnostic yield.

Background & Aims Hospitalization is associated with inadequate colon cleansing before colonoscopy. We aimed to identify factors associated to inadequate colon cleansing among inpatients, and to derive and validate a model to identify inpatients with inadequate cleansing. Methods We performed a prospective observational study at 12 hospitals in Italy. Consecutive adult inpatients scheduled for colonoscopy for any indication were enrolled from February through May 2019 (derivation cohort, n = 1016) and from June through August 2019 (validation cohort, n = 508). Inadequate cleansing was defined as Boston bowel preparation scale scores below 2 in any colon segment. We performed multivariate logistic regression to identify factors associated with inadequate cleansing. Results In the combined cohorts, 1032 patients (68%) had adequate colon cleansing. Physicians’ meetings to optimize bowel preparation (odds ratio [OR], 0.42; 95% CI, 0.27–0.65), written and oral instructions to patients (OR, 0.48; 95% CI, 0.36–0.65), admission to gastroenterology unit (OR, 0.71; 95% CI, 0.51–0.98), split-dose regimens (OR, 0.27; 95% CI, 0.20–0.35), a 1-liter polyethylene glycol-based bowel purge (OR, 0.39; 95% CI, 0.23—0.65), and 75% or more intake of bowel preparation (OR, 0.09; 95% CI, 0.05–0.15) significantly reduced odds of inadequate colon cleansing. Alternatively, bedridden status (OR, 2.14; 95% CI, 1.55–2.98), constipation (OR, 2.16; 95% CI, 1.55–3.0), diabetes mellitus (OR, 1.61; 95% CI, 1.18–2.20), use of anti-psychotic drugs (OR, 3.26; 95% CI, 1.62–6.56), and 7 or more days of hospitalization (OR, 1.02; 95% CI, 1.00–1.04) increased risk of inadequate colon cleansing. We developed a model to identify patients with inadequate cleaning using data from patients in the derivation cohort and tested it in the validation cohort. Calibration values were P = .218 for the discrimination cohort and P = .232 for the validation cohort. Discrimination values were c-statistic, 0.78 (95% CI, 0.74–0.81) for the discrimination cohort and c-statistic, 0.73 (95% CI, 0.69–0.78) for the validation cohort. We developed app for use by clinicians. Conclusions In a prospective observational study, we identified setting-, patient- and preparation-related factors that affect colon cleansing among inpatients. We derived and validated a model to identify patients with inadequate preparation and developed an app for clinicians. ClinicalTrials.gov no: NCT03925506

We sought to study the relationship between serum pepsinogens and different histopathologic features of Helicobacter pylori-related chronic gastritis. One hundred forty-nine consecutive dyspeptic patients underwent endoscopy with biopsies; serum pepsinogens I and II were measured by immunoassay. Serum levels of pepsinogens (sPG) were significantly correlated with H. pylori density both of the corpus (sPGI: r = 0.32, P < .001; sPGII: r = 0.56, P < .001) and antrum (sPGI: r = 0.41, P < .001; sPGII: r = 0.43, P < .001) as well as with chronic inflammation (sPGI: r = 0.26, P < .001; sPGII: r = 0.49, P < .001) and activity (sPGI: r = 0.38, P < .001; sPGII: r = 0.50, P < .001) in the antrum. Only sPGII was correlated with chronic inflammation (r = 0.44, P < .001) and activity (r = 0.40, P < .001) in the corpus. SPGI was inversely correlated with atrophy (r = -0.33, P < .001) and intestinal metaplasia (r = -0.37, P < .001) in the corpus. sPGII levels could be considered as markers of gastric inflammation all over in the stomach. sPGI levels are inversely related to atrophic body gastritis.

Background. Several tests have been proposed for evaluating dyspeptic symptoms and their relationship to the underlying gastric disease. Serum pepsinogens and gastrin-17 are known to be useful biomarkers for the detection of gastric pathologies. Aim. To evaluate the capability of screening dyspeptic patients in the primary care by analyses of serum pepsinogens I (sPGI) and II (sPGII), gastrin-17 (sG-17) and the IgG anti- Helicobacter pylori antibodies (IgG-Hp). Patients and methods. Three hundred and sixty-two consecutive patients with dyspeptic symptoms (208 females, mean age 50.6 ± 16 years, range 18–88 years) referred by general practitioners for upper gastrointestinal endoscopy were enrolled. A blood sample was taken from each subject for IgG-Hp, sPGI, sPGII and sG-17 analyses. Results. Two hundred and eighty-seven patients had a complete screening; of these, 132 resulted positive for Hp infection. Patients with atrophic chronic gastritis showed significantly lower serum pepsinogen I levels and sPGI/sPGII ratio than patients with non-atrophic chronic gastritis. Moreover, by calculating the values of sPGI by sG-17 and sG-17 by sPGII/sPGI, subjects with atrophic chronic gastritis could be distinguished from those with non-atrophic chronic gastritis and from those with normal mucosa, respectively. sG-17 levels were found to be a useful biomarker for the detection of antral atrophic gastritis, while the combination of sPGI, the sPGI/sPGII ratio and sG-17 was found effective in identifying corpus atrophy. Conclusion. A panel composed of PGI, PGII, G-17 and IgG-Hp could be used as a first approach in the ‘test and scope’ and/or ‘test and treat’ strategy in the primary care management of dyspeptic patients.

Background. One-week triple therapy is the most frequently recommended treatment for Helicobacter pylori infection. Eradication rate is satisfactory, nevertheless is advisable to look for more effective therapies. Aim. To test the efficacy of a standard triple therapy plus bovine lactoferrin in the eradication of H. pylori infection. Patients and Methods. One hundred and fifty consecutive H. pylori positive patients, suffering from dyspeptic symptoms were recruited in a 7-day triple therapy open randomised single centre study with rabeprazole, clarithromycin, tinidazole, bovine lactoferrin (group A) or rabeprazole, clarithromycin, tinidazole (group B), or a 10-day therapy with rabeprazole, clarithromycin, tinidazole (group C). H. pylori status was assessed 8 weeks after the end of the treatment by means of a 13 C-urea breath test or a H. pylori stool antigen-test. Results. Eradication rates (intention to treat/per protocol) were: group A (92.2/95.9%), group B (71.2/72.5%) and group C (70.2/75%). The efficacy of triple therapy added with lactoferrin was significantly higher than other two regimens ( p =0.01, intention to treat analysis; p =0.005, per protocol analysis). Conclusion. These results suggest that lactoferrin tested in the present study was effective in curing H. pylori and could be a new agent to assist the antimicrobials in the eradication of the bacterium.

Aim: Many data regarding omeprazole-, lanzoprazole- and pantoprazole-based triple therapy for Helicobacter pylori (H. pylori) eradication have been reported, but there is few data present regarding rabeprazole (R). We report the efficacy and tolerability of rabeprazole in different dosages in association with clarithromycin (C)and tinidazole (T) in H. pylori eradication. Design and Methods: Ninety-four H. pylori-positive patients with dyspeptic symptoms were enrolled and randomly allocated to eradication therapy in two different one-week regimens. In regimen A, 47 patients received R 20 mg b.i.d, C 500 mg b.i.d and T 500 mg b.i.d, while in regimen B, 47 patients received R 10 mg b.i.d, C 500 mg b.i.d and T 500 mg b.i.d. Eradication of H. pylori was evaluated by a 13C urea breath test (UBT) two months after the end of the therapy. Results: Four patients (two in each regimen) did not complete treatment. The H. pylori eradication rate was 91.4% in group A compared to 89.3% in group B (P-value not significant). Minor side-effects were reported in 4.2% of group A and 6.4% of group B patients. Conclusion: Rabeprazole showed good efficacy and tolerability in one-week H. pylori therapy at 20 mg b.i.d and 10 mg b.i.d, suggesting the use of the lower dosage. © 2003 Blackwell Publishing Asia Pty Ltd