Fausto Chilovi

Clinical trial on the efficacy of a new symbiotic formulation, Flortec, in patients with irritable bowel syndrome: a multicenter, randomized study.

Objectives Efficacy of symbiotics in patients with irritable bowel syndrome (IBS) remains unknown. Methods Patients were randomized to a prebiotic (n=135), or a symbiotic formulation containing Lactobacillus paracasei B21060 (Flortec, n=132). Primary efficacy was the responder rate for pain and global relief of symptoms in the overall population and in patients with predominant diarrhea (n=47). Post hoc time-trend analyses for changes within each treatment were carried out. Results Patients with absent/mild pain amounted to 54.7% in the symbiotic group and to 57.4% in the prebiotic group at treatment week 4, and to 53.9% and 53.4% at the end of treatment. Patients with amelioration of well-being were, respectively, 60.7% versus 61.7% at treatment week 4, and 63.3% versus 60.9% at the end of treatment. Within each treatment group, patients with absent/mild pain increased in the Flortec and the prebiotic group, but time trend analyses were significant only for Flortec (P=0.019). In IBS-predominant diarrhea, Flortec significantly reduced bowel movements, pain, and IBS scores. Conclusions To improve pain and well-being, Flortec is encouraging in patients with diarrhea predominant IBS. To establish its efficacy for the majority of IBS patients, Flortec has to be compared with an inert placebo in future work.

Development and Validation of an Endoscopic Classification of Diverticular Disease of the Colon: The DICA Classification

Background: A validated endoscopic classification of diverticular disease (DD) of the colon is lacking at present. Our aim was to develop a simple endoscopic score of DD: the Diverticular Inflammation and Complication Assessment (DICA) score. Methods: The DICA score for DD resulted in the sum of the scores for the extension of diverticulosis, the number of diverticula per region, the presence and type of inflammation, and the presence and type of complications: DICA 1 (≤3), DICA 2 (4-7) and DICA 3 (>7). A comparison with abdominal pain and inflammatory marker expression was also performed. A total of 50 videos of DD patients were reassessed in order to investigate the predictive role of DICA on the outcome of the disease. Results: Overall agreement in using DICA was 0.847 (95% confidence interval, CI, 0.812-0.893): 0.878 (95% CI 0.832-0.895) for DICA 1, 0.765 (95% CI 0.735-0.786) for DICA 2 and 0.891 (95% CI 0.845-0.7923) for DICA 3. Intra-observer agreement (kappa) was 0.91 (95% CI 0.886-0.947). A significant correlation was found between the DICA score and C-reactive protein values (p = 0.0001), as well as between the median pain score and the DICA score (p = 0.0001). With respect to the 50 patients retrospectively reassessed, occurrence/recurrence of disease complications was recorded in 29 patients (58%): 10 (34.5%) were classified as DICA 1 and 19 (65.5%) as DICA 2 (p = 0.036). Conclusions: The DICA score is a simple, reproducible, validated and easy-to-use endoscopic scoring system for DD of the colon.

Interobserver agreement in describing video capsule endoscopy findings: a multicentre prospective study.

BACKGROUND AND AIMnFew studies have specifically addressed interobserver agreement in describing lesions identified during capsule endoscopy. The aim of our study is to evaluate interobserver agreement in the description of capsule endoscopy findings.nnnMATERIALS AND METHODSnConsecutive short segments of capsule endoscopy were prospectively observed by 8 investigators. Seventy-five videos were prepared by an external investigator (gold standard). The description of the findings was reported by the investigators using the same validated and standardized capsule endoscopy structured terminology. The agreement was assessed using Cohens kappa statistic.nnnRESULTSnAs concerns the ability to detect a lesion, the agreement with the gold standard was moderate (kappa 0.48), as well as the agreement relating to the final diagnosis (κ 0.45). The best agreement was observed in identifying the presence of active bleeding (κ 0.72), whereas the poorest agreement concerned the lesion size (κ 0.32). The agreement with the GS was significantly better in endoscopists with higher case/volume of capsule endoscopy per year. Diagnostic concordance was better in the presence of angiectasia than in the presence of polyps or ulcers/erosions.nnnCONCLUSIONSnCorrect lesion identification and diagnosis seem more likely to occur in presence of angiectasia, and for readers with more experience in capsule endoscopy reading.

The "Prometeo" study: online collection of clinical data and outcome of Italian patients with acute nonvariceal upper gastrointestinal bleeding.

Goals: To implement an online, prospective collection of clinical data and outcome of patients with acute nonvariceal upper gastrointestinal bleeding (UGIB) in Italy (“Prometeo” study). Background: Epidemiology, clinical features, and outcomes of nonvariceal UGIB are mainly known by retrospective studies and are probably changing. Study: Data were collected by 13 Gastrointestinal Units in Italy from June 2006 to June 2007 (phase 1) and from December 2008 to December 2009 (phase 2): an interim analysis of data was performed between the 2 phases to optimize the online database. All the patients consecutively admitted for acute nonvariceal UGIB were enrolled. Demographic and clinical data were collected, a diagnostic endoscopy performed, with endoscopic hemostasis if indicated. Results: One thousand four hundred thirteen patients (M=932, mean age±SD=66.5±15.8; F=481, mean age±SD=74.2±14.6) were enrolled. Comorbidities were present in 83%. 52.4% were treated with acetyl salicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs): only 13.9% had an effective gastroprotection. Previous episodes of UGIB were present in 13.3%. Transfusion were needed in 43.9%. Shock was present in 9.3%. Endoscopic diagnosis was made in 93.2%: peptic lesions were the main cause of bleeding (duodenal ulcer 36.2%, gastric ulcer 29.6%, gastric/duodenal erosions 10.9%). At endoscopy, Helicobacter pylori was searched in 37.2%, and found positive in 51.3% of tested cases. Early rebleeding was observed in 5.4%: surgery was required in 14.3% of them. Bleeding-related death occurred in 4.0%: at multivariate analysis, the risk of death was correlated with female sex [odds ratio (OR=2.19, P=0.0089)], presence of neoplasia (OR=2.70, P=0.0057) or multiple comorbidities (OR=5.04, P=0.0280), shock at admission (OR=4.55, P=0.0001), and early rebleeding (OR=1.47, P=0.004). Conclusions: Prometeo database has provided an up-to-date picture of acute nonvariceal UGIB in Italy: patients are elderly, predominantly males, and with important comorbidities. Gastroprotection is underutilized during NSAIDs treatment. With respect to previous studies, Prometeo shows a higher incidence of low-dose acetyl salicylic acid use and comorbidities, whereas no significant difference were found in other items (etiology of bleeding, NSAIDs use, need for endoscopic hemostasis, incidence of rebleeding, and overall mortality).

Weekend Effect in Non-Variceal Upper Gastrointestinal Bleeding: Data From Nine Italian Gastrointestinal Units

Weekend Effect in Non-Variceal Upper Gastrointestinal Bleeding: Data From Nine Italian Gastrointestinal Units