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Background and aims: The optimal management of naïve and not naïve Helicobacter pylori patients remains unclear. Therefore, it is essential to evaluate whether the actual clinical practice mirrors the indications suggested by the guidelines. This study aimed to assess the effectiveness and the safety of the empirical first- and second-line treatments prescribed to patients enroled at Italian centres participating in the European Registry on H. pylori Management (Hp-EuReg). Methods: The Hp-EuReg is an international multicentre prospective non-interventional registry starting in 2013 aiming to evaluate the management of H. pylori infection by European gastroenterologists. Patients were registered in an e-CRF by AEG-REDCap. Variables assessed included demographics, previous eradication attempts, treatment regimen, effectiveness, and tolerance. Results: Overall, 3723 patients from 2013 to February 2021 were included: 2996 and 727 received an empirical first- and second-line treatment, respectively. According to the modified ITT analysis, among the first-line regimens, only the bismuth quadruple therapy with three-in-one-single capsule (BQT-TSC), the concomitant, and the sequential treatment - all lasting 10 days - achieved an eradication rate >90%. Among the second-line regimens, only the 10-day BQT-TSC reported an effectiveness >90%. High-dose PPI twice daily also significantly increased the effectiveness of some therapies. The BQT-TSC was the regimen with the highest incidence of adverse events. Conclusions: Only quadruple therapies lasting at least 10 days achieved over 90% eradication rates among the empirical first- and second-line regimens. It remains unclear whether high-dose PPI twice daily can improve the efficacy of quadruple treatment.

Background and aims: Several methods are available to diagnose Helicobacter pylori infection. Our objective was to evaluate the tests used for both the initial diagnosis and the confirmation of eradication after treatment in Europe. Methods: The European Registry on the management of Helicobacter pylori infection is an international, multicentre, prospective, non-interventional registry aiming to evaluate the management of Helicobacter pylori-infected patients in Europe. Countries with at least 100 cases registered from June 2013 to April 2021, and with a validated diagnostic method were analysed. Data were quality reviewed. Results: A total of 34,920 adult patients from 20 countries were included (mean age 51 years; 61% women). To establish the initial diagnosis, invasive tests were performed in 19,801 (71%) patients, non-invasive in 11,369 (41%), and both in 3437 (12%). The most frequent were histology (n = 11,885; 43%), a rapid urease test (n = 10,636; 38%) and an urea breath test (n = 7577; 27%). According to the age, invasive tests were indicated in 11,179 (77%) ≥50 years, and in 8603 (65%)

COVID-19-associated acute kidney injury (AKI) represents an independent risk factor for all-cause in-hospital death in patients with COVID-19. Chronic statin therapy use is highly prevalent in individuals at risk for severe COVID-19. Our aim is to assess whether patients under treatment with statins have a lower risk of AKI and in-hospital mortality during hospitalization for interstitial SARS-CoV2 pneumonia.Our study is a prospective observational study on 269 consecutive patients admitted for COVID-19 pneumonia at the Internal Medicine Unit of IRCCS Sant'Orsola Hospital in Bologna, Italy. We compared the clinical characteristics between patients receiving statin therapy (n = 65) and patients not treated with statins and we assessed if chronic statin use was associated with a reduced risk for AKI, all-cause mortality, admission to ICU, and disease severity. Statin use was associated with a significant reduction in the risk of developing AKI (OR 0.47, IC 0.23 to 0.95, p 0.036) after adjustment for age, sex, BMI, hypertension, diabetes, and chronic kidney disease (CKD). Additionally, statin use was associated with reduced C-reactive protein (CRP) levels (p 0.048) at hospital admission. No significant impact in risk of all-cause mortality (HR 1.98, IC 0.71 to 5.50, p 0.191) and ICU admission (HR 0.93, IC 0.52 to 1.65, p 0.801) was observed with statin use, after adjustment for age, sex, BMI, hypertension, diabetes, and CKD.The present study shows a potential beneficial effect of statins in COVID-19-associated AKI. Furthermore, patients treated with statins before hospital admission for COVID-19 may have lower systemic inflammation levels.

First-lineInternational multicentre prospective non-interventional European Registry onOverall, 500 patients included in the Hp-EuReg were treated with rifabutin (mean age 52 years, 72% female, 63% with dyspepsia, 4% with peptic ulcer). Culture was performed in 63% of cases: dual resistance (to both clarithromycin and metronidazole) was reported in 46% of the cases, and triple resistance (to clarithromycin, metronidazole, and levofloxacin) in 39%. In 87% of cases rifabutin was utilised as part of a triple therapy together with amoxicillin and a proton-pump-inhibitor, and in an additional 6% of the patients, bismuth was added to this triple regimen. Rifabutin was mainly used in second-line (32%), third-line (25%), and fourth-line (27%) regimens, achieving overall 78%, 80% and 66% effectiveness by modified intention-to-treat, respectively. Compliance with treatment was 89%. At least one adverse event was registered in 26% of the patients (most frequently nausea), and one serious adverse event (0.2%) was reported in one patient with leukopenia and thrombocytopenia with fever requiring hospitalisation.Rifabutin-containing therapy represents an effective and safe strategy after one or even several failures of

Candida spp. are commensal organisms of the skin, mucous membranes, gastrointestinal tract, blood, and vagina of animals and humans. In recent decades, the incidence of human fungal infections has increased, with Candida spp. (mainly C. albicans) infections being the most frequent, and the treatment of fungal infections is still a clinical challenge. Colonization of the human gastrointestinal tract by Candida spp. is significant because infections (e.g., candidemia and vulvovaginal candidiasis) frequently arise from commensal microorganisms. The aim of this study was to test in vitro the antifungal activity and the eventual synergistic effect of five pure components of essential oils: cinnamaldehyde, α-pinene, limonene, eucalyptol, and eugenol. These compounds were tested on 18 Candida strains (15 C. albicans, 2 C. glabrata, and 1 C. lusitaniae) derived from a culture collection of vaginal clinical strains. Methods: Fungistatic activity was evaluated using the disk diffusion method. For fungicidal activity, microdilution and time–kill curve protocols were set up. The checkerboard method was chosen to evaluate a possible synergistic effect of these compounds when mixed. Results: Cinnamaldehyde and eugenol gave the best results, inhibiting all the Candida strains and showing a highly additive effect (FICI 0.625). The cinnamaldehyde inhibition zone (IZ), MIC, and MFC means were 69 mm, 50.05 mg/L, and 109.26 mg/L respectively. Cinnamaldehyde led to the total loss of viable Candida cells within 4 h. Eugenol IZ, MIC, and MFC means were 35.2 mm, 455.42 mg/L, and 690.09 mg/L, respectively. Eugenol led to the total loss of viable fungal cells within 1 h. Treatment with α-pinene inhibited 88.9% of Candida strains, with an IZ mean of 21.2 mm, a MIC mean of 195.41 mg/L, and a MFC mean of 251.27 mg/L; this compound led to the total loss of viable fungal cells only after 24 h. Limonene inhibited only 33.3% of the tested strains and eucalyptol did not produce an inhibition halo, so these compounds were not tested further. Conclusions: These characteristics, together with the well-known safety of cinnamaldehyde and eugenol for human use, make these two natural compounds the perfect candidates for the treatment of candidiasis. This was a pilot study, the purpose of which was to evaluate the best composition of a mixture to be used against intestinal and vulvovaginal candidiasis; in vivo studies are needed to confirm these very encouraging results.

Background and aims: Helicobacter pylori prevalence remains high worldwide, especially in developing areas where infection acquisition occurs in early childhood. H. pylori eradication fails in a definite number of patients, despite one or more therapeutic attempts. Curing these patients is progressively more difficult, due to development of antibiotic resistance. While the cure rate of first-line therapies in foreigners was found to be different from that of Italians, no data are available on rescue therapies. Materials and methods: Consecutive foreigner patients with H. pylori infection following at least one therapy failure were enrolled. All patients underwent upper endoscopy with gastric biopsies used for both histologic examination and culture/susceptibility test. Rescue therapies administered accordingly to susceptibility testing were rifabutin-based therapy, levofloxacin-based therapy, sequential. Pylera was prescribed regardless the resistance pattern. Results: A total of 103 (M/F: 27/76, mean age: 41.9 y, range: 18 to 85) were enrolled. The overall resistance rates toward clarithromycin, metronidazole, and levofloxacin were 76.7%, 66%, and 42.7%, respectively, with triple resistance present in 33.9% of bacterial isolates. Eradication rates were 71.4% on 40 patients for rifabutin-based therapy, 82.8% on 42 cases for levofloxacin-based therapy, 75% on 11 patients treated with sequential therapy, and 100% on 10 cases who received Pylera regimen. Conclusions: To our knowledge, this is the first study assessing H. pylori eradication rates in foreigner patients, who failed at least one therapeutic attempt, managed in Italy. Even by using a culture-based approach, the infection was not cured in a definite number of patients.

Treatment of Helicobacter pylori (H. pylori) infection is a challenge for clinicians. The large increase in drug-resistant strains makes the formulation of new therapeutic strategies fundamental. The frequent onset of side effects during antibiotic treatment (mainly due to intestinal dysbiosis) should not be underestimated as it may cause the interruption of treatment, failure of H. pylori eradication and clonal selection of resistant bacteria. Probiotic integration during antibiotic treatment can exert a dual function: a direct antagonistic effect on H. pylori and a balancing effect on dysbiosis. Therefore, it fulfills the definition of a new therapeutic strategy to successfully treat H. pylori infection. Data reported in literature give promising but discrepant results. Aim: To assess in vitro bacteriostatic and bactericidal activity of probiotic strains against H. pylori. Materials and methods: L. casei, L. paracasei, L. acidophilus, B. lactis and S. thermophilus strains were used. Agar well diffusion and time-kill curves were carried out to detect bacteriostatic and bactericidal activity, respectively. Results: All probiotic strains showed both bacteriostatic and bactericidal activity vs. H. pylori. Conclusions: Such findings prompted us to plan a protocol of treatment in which probiotics are given to infected patients in association with antibiotic therapy.

Background/Aims: Curing Helicobacter pylori infection remains challenging for clinicians, as no proposed first-line therapy achieves bacterial eradication in all treated patients so that several patients need two or more consecutive treatments. Bacterial culture with antibiotics susceptibility testing is largely unachievable in Italy, and empiric second-line and rescue therapies are generally used. This study aimed to identify what eradication regimens perform better in Italy, following first-line therapy failure. Methods: We performed a literature search on PubMed for studies on standard therapy regimens used as second-line or rescue treatments performed in adult patients. Studies including modified drug combinations were not considered. Both intention-to-treat and per- protocol analyses were computed for each therapy subgroup. Results: Data from 35 studies with a total of 4830 patients were eventually considered. As a second-line therapy, Pylera® (90.6%) and a sequential regimen (89.8%) achieved eradication rates significantly higher than other therapies. For third-line therapy, a levofloxacin-based regimen and Pylera® achieved comparable eradication rates (88.2% vs. 84.7%; p = 0.2). Among therapies used as fourth (or more) attempts, Pylera® and a rifabutin-based therapy achieved 77.4% and 66.4% cure rates, respectively (p = 0.013). A therapy sequence based on the type of first-line therapy used was proposed. Conclusions: Data obtained through our review indicate that standard therapies for H. pylori eradication can be used when following an appropriate sequence, allowing clinicians to improve the cure rate without resorting to bacterial culture.

Background/Aims: Curing Helicobacter pylori infection remains challenging for clinicians, as no proposed first-line therapy achieves bacterial eradication in all treated patients so that several patients need two or more consecutive treatments. Bacterial culture with antibiotics susceptibility testing is largely unachievable in Italy, and empiric second-line and rescue therapies are generally used. This study aimed to identify what eradication regimens perform better in Italy, following first-line therapy failure. Methods: We performed a literature search on PubMed for studies on standard therapy regimens used as second-line or rescue treatments performed in adult patients. Studies including modified drug combinations were not considered. Both intention-to-treat and per- protocol analyses were computed for each therapy subgroup. Results: Data from 35 studies with a total of 4830 patients were eventually considered. As a second-line therapy, Pylera® (90.6%) and a sequential regimen (89.8%) achieved eradication rates significantly higher than other therapies. For third-line therapy, a levofloxacin-based regimen and Pylera® achieved comparable eradication rates (88.2% vs. 84.7%; p = 0.2). Among therapies used as fourth (or more) attempts, Pylera® and a rifabutin-based therapy achieved 77.4% and 66.4% cure rates, respectively (p = 0.013). A therapy sequence based on the type of first-line therapy used was proposed. Conclusions: Data obtained through our review indicate that standard therapies for H. pylori eradication can be used when following an appropriate sequence, allowing clinicians to improve the cure rate without resorting to bacterial culture.

Cure rate following standard first-line regimens for Helicobacter pylori eradication is decreasing so several patients require two or more treatments. Antibiotic susceptibility-based therapy, advised in current guidelines, is largely impracticable in clinical practice. Some 'standard' regimens (triple therapies based on either levofloxacin or rifabutin, bismuth-based quadruple therapies, sequential, concomitant and hybrid therapies) were empirically used as rescue therapies. We performed a systematic review on recent studies carried out in European countries dealing with these regimens. A total of 24 studies, with 3804 patients, were identified. As second-line therapy, Pylera (89.2%) and sequential therapy (92.5%) achieved significantly higher cure rates as compared to all the other regimens. As third-line therapy, levofloxacin-based therapy (84.1%) and Pylera (83.6%) achieved similarly high cure rates, whereas standard, bismuth-based quadruple therapy (64.1%) achieved the lowest. As a rescue therapy, the success rate was close to 75% following all therapies used, with data on rifabutin-based regimen consolidated in the larger sample size. Overall, levofloxacin-amoxicillin triple therapy achieved higher eradication rates when the 14- rather than 10-day regimen was used (87.1 vs. 72.2%; P = 0.003). Among bismuth-based therapies, Pylera achieved a significantly higher eradication rate than standard quadruple therapy (88 vs. 67%; P

Background and aims Helicobacter pylori prevalence remains high worldwide, especially in developing areas where infection acquisition occurs in early childhood. H. pylori eradication fails in a definite number of patients, despite one or more therapeutic attempts. Curing these patients is progressively more difficult, due to development of antibiotic resistance. While the cure rate of first-line therapies in foreigners was found to be different from that of Italians, no data are available on rescue therapies. Materials and methods Consecutive foreigner patients with H. pylori infection following at least one therapy failure were enrolled. All patients underwent upper endoscopy with gastric biopsies used for both histologic examination and culture/susceptibility test. Rescue therapies administered accordingly to susceptibility testing were rifabutin-based therapy, levofloxacin-based therapy, sequential. Pylera was prescribed regardless the resistance pattern. Results A total of 103 (M/F: 27/76, mean age: 41.9 y, range: 18 to 85) were enrolled. The overall resistance rates toward clarithromycin, metronidazole, and levofloxacin were 76.7%, 66%, and 42.7%, respectively, with triple resistance present in 33.9% of bacterial isolates. Eradication rates were 71.4% on 40 patients for rifabutin-based therapy, 82.8% on 42 cases for levofloxacin-based therapy, 75% on 11 patients treated with sequential therapy, and 100% on 10 cases who received Pylera regimen. Conclusions To our knowledge, this is the first study assessing H. pylori eradication rates in foreigner patients, who failed at least one therapeutic attempt, managed in Italy. Even by using a culture-based approach, the infection was not cured in a definite number of patients.

Background: Helicobacter pylori (H. pylori) infection is the leading cause of both peptic ulcers and gastric tumors, including low-grade MALT-lymphoma and adenocarcinoma. Although it is decreasing in developed countries, H. pylori prevalence remains high in developing areas, mainly due to low socio-economic levels, and the potential consumption of contaminated water. Moreover, a different pattern of primary antibiotic resistance is expected in their H. pylori isolates, potentially affecting the efficacy of standard eradication therapies. Indeed, a previous study showed the eradication rate following triple therapy was distinctly lower in dyspeptic H. pylori infected immigrants living in Italy as compared to Italian patients. Aims: to evaluate the resistance pattern in H. pylori isolates from immigrant patients in Italy, and the success rate of first-line therapy in these patients. Materials and Methods: This retrospective study evaluated data of consecutive immigrant patients, diagnosed with H. pylori infection in a single center (Bologna, Italy) between January 2009 and January 2019. Patients underwent first-line therapy with either sequential or Pylera&reg, (Allergan USA, Inc. Madison, NJ, USA) therapy. Results: A total of 609 immigrants were diagnosed with H. pylori infection during the study period, but 264 previously received an eradication therapy. Therefore, the study was focused on 294 out of 345 na&iuml, ve patients with a successful bacterial culture with antibiogram. Latin America immigrants had the highest overall resistance rate. Levofloxacin resistance rate was significantly higher in Latin Americans and Asians as compared with Europeans. Based on resistance patterns, sequential therapy showed a clear decreasing trend in eradication rates. Conclusions: while antibiotic resistance rates are generally increasing worldwide, Pylera&reg, seems to achieve a good performance as first-line treatment in all na&iuml, ve foreigner patients, except for Africans.

Background: Helicobacter pylori (H. pylori) infection is the leading cause of both peptic ulcers and gastric tumors, including low-grade MALT-lymphoma and adenocarcinoma. Although it is decreasing in developed countries, H. pylori prevalence remains high in developing areas, mainly due to low socio-economic levels, and the potential consumption of contaminated water. Moreover, a different pattern of primary antibiotic resistance is expected in their H. pylori isolates, potentially affecting the efficacy of standard eradication therapies. Indeed, a previous study showed the eradication rate following triple therapy was distinctly lower in dyspeptic H. pylori infected immigrants living in Italy as compared to Italian patients. Aims: to evaluate the resistance pattern in H. pylori isolates from immigrant patients in Italy, and the success rate of first-line therapy in these patients. Materials and Methods: This retrospective study evaluated data of consecutive immigrant patients, diagnosed with H. pylori infection in a single center (Bologna, Italy) between January 2009 and January 2019. Patients underwent first-line therapy with either sequential or Pylera® (Allergan USA, Inc. Madison, NJ, USA) therapy. Results: A total of 609 immigrants were diagnosed with H. pylori infection during the study period, but 264 previously received an eradication therapy. Therefore, the study was focused on 294 out of 345 naïve patients with a successful bacterial culture with antibiogram. Latin America immigrants had the highest overall resistance rate. Levofloxacin resistance rate was significantly higher in Latin Americans and Asians as compared with Europeans. Based on resistance patterns, sequential therapy showed a clear decreasing trend in eradication rates. Conclusions: while antibiotic resistance rates are generally increasing worldwide, Pylera® seems to achieve a good performance as first-line treatment in all naïve foreigner patients, except for Africans.

Helicobacter pylori (H. pylori) eradication fails in a definite amount of patients despite one or more therapeutic attempts. Curing these patients is progressively more difficult, due to development of antibiotic resistance. Current guidelines suggest testing antibiotic susceptibility in H. pylori isolates following two therapeutic attempts. Aim: to evaluate the development of antibiotic resistance, MIC values trends and therapeutic outcomes in patients who failed at least one H. pylori eradication therapy. Methods: consecutive patients, referred to perform upper gastrointestinal endoscopy (UGIE) to our Unit from January 2009 to January 2019 following at least one therapeutic attempt were considered. Bacterial resistance towards clarithromycin, metronidazole and levofloxacin was tested. Patients received either a susceptibility-guided therapy or Pylera&reg, Results: a total of 1223 patients were H. pylori positive, and antibiotic susceptibility was available for 1037. The rate of antibiotic resistance and MIC values significantly increased paralleling the number of previous therapeutic attempts. Eradication rates of antibiogram-tailored therapies remained stable, except for the sequential therapy if used as a third line. As a rescue treatment, the Pylera&reg, therapy achieved cure rates comparable to those of the other culture-guided therapies. Conclusions: A significant increase in the secondary resistance towards the three tested antibiotics was observed, both as rate and MIC values, in correlation with the number of therapy failures. These findings should be considered when administering an empirical second-line therapy. Pylera&reg, therapy eradication rates are comparable to culture-tailored therapies.

There are no evidence-based recommendations for performing upper gastrointestinal endoscopy (UGIE) in patients with extra-oesophageal symptoms of gastro-oesophageal reflux disease (GORD). However, UGIEs are often performed in clinical practice in these patients. We aimed to assess the prevalence of gastro-oesophageal lesions in patients with atypical GORD symptoms.Patients complaining of at least one extra-oesophageal GORD symptom and undergoing UGIE in seven centres were prospectively enrolled. Clinically relevant lesions (Barrett's oesophagus, erosive oesophagitis, gastric precancerous conditions, peptic ulcer, cancer, andTwo hundred eleven patients were enrolled (male/female: 74/137; mean age: 55.5 ± 14.7 years). Barrett's oesophagus was detected in 4 (1.9%), erosive oesophagitis in 12 (5.7%), gastric precancerous conditions in 22 (10.4%), andClinically relevant lesions are uncommon among young (≤50 years) patients with extra-oesophageal GORD symptoms. Hiatal hernia is not more prevalent in patients with cardiologic symptoms and suspicion of GORD. The usefulness of UGIE in these patients is questionable.Não existem recomendações baseadas na evidencia para realização de endoscopia digestiva alta (EDA) em doentes com sintomas extra-esofágicos da doença de refluxo gastroesofágico (DRGE). No entanto, EDAs são frequentemente realizadas na orientação clínica destes doentes. O nosso objectivo foi a valiar a prevalência de lesões gastro-esofágicas em doentes com sintomas atípicos de DRGE.Doentes com pelo menos um sintoma extra-esofágico de DRGE e que realizaram EDA em 7 centros foram prospectivamente recrutados. Lesões clinicamente relevantes (esófago de Barrett, esofagite erosiva, condições pré-malignas gástricas, úlcera péptica, cancro e infecção H. pylori) foram estatisticamente comparadas entre os grupos tendo em conta sintomas de DRGE (atípicos vs. quer típicos e atípicos), tipo de sintomas atípicos, idade e presenta de hérnia do hiato.Duzentos e onze doentes foram recrutados (H/M: 74/137; Idade média: 55.5 ± 14.7 anos). Esófago de Barrett foi detetado em 4 (1.9%), esofagite erosiva em 12 (5.7%), condições pré-malignas gástricas em 22 (10.4%) e infeção H. pylori em 38 (18%) doentes. A prevalência de lesões clinicamente relevantes foi inferior em doentes com apenas sintomas atípicos (28.6 vs. 42,5%; p = 0.046; teste de qui-quadrado), doentes com50 anos (20 vs. 44.8%; p = 0.004; teste de qui-quadrado), e nos doentes medicados com iniciadores da bomba de protões (IBP) (21.1 vs.40.2%; p = 0.01; teste de qui-quadrado). Nenhuma lesáo clinicamente relevante foi detectada nos doentes com50 anos, sem sintomas de alarme e medicados com IBP. Hérnia do hiato foi diagnosticada apenas em 6 doentes com sintomas do tipo cardíaco e em 41 com sintomas ORLs (11.3 vs. 35.1%; p = 0.03; teste de qui-quadrado).Lesões clinicamente relevantes são incomuns em doentes jovens com sintomas extra-esofágicos de DRGE. Hérnia do hiato não é mais prevalente em doentes com sintomas do tipo cardíaco e suspeita de DRGE. A utilidade da EDA nestes doentes é discutível.

Nonerosive reflux disease (NERD) is a gastrointestinal disorder that leads to symptoms such as heartburn and regurgitation without visible esophageal mucosal injury, and it is treated with proton-pump inhibitors (PPIs). CHETOGERD

Nonerosive reflux disease (NERD) is a gastrointestinal disorder that leads to symptoms such as heartburn and regurgitation without visible esophageal mucosal injury, and it is treated with proton-pump inhibitors (PPIs). CHETOGERD® gel or orosoluble (oro) formulations-an association of natural active ingredient: hyaluronic acid, altea, malva, apple active TM, Aloe vera, L-triptophan, calcium gluconate, sodium bicarbonate, Musa paradisiaca)-may be an alternative or a coadjutant treatment in patients with NERD. The aim of the study was to evaluate, prospectively, the efficacy of CHETOGERD® gel and oro in inducing symptom's reduction or remission, in consecutive patients with NERD. Patients were divided in two groups and treated with CHETOGERD® gel or CHETOGERD® oro, 3 sachets/day for 3 months, decreased to 1 sachet/day for other 3 months. Symptoms were evaluated at baseline, 3 and 6 months using the reflux disease questionnaire (RDQ). Symptoms' remission was defined as reduction of retrosternal pain or burning, epigastric pain or burning, regurgitation and acid sensation in mouth. Frequency, distribution analyses and non-parametric tests were used for the statistical analysis. Results were considered statistically significant for p values < 0.05. Four hundred and twenty-three patients (M/F 240/183; mean age 50 years) were diagnosed with NERD and were consecutively enrolled. 146 patients underwent therapy with CHETOGERD® gel, while 277 were treated with CHETOGERD® oro. 108 patients from the first group and 172 patients from the second group completed follow up at 3 months, while 100 patients from each group completed follow-up at 6 months. Both formulations were able to significantly reduce the frequency and intensity of symptoms analysed with RDQ. No adverse events were reported. CHETOGERD® gel and oro are two valid alternatives to control symptoms in patients with nonerosive reflux disease.

Background. Antigens derived from Helicobacter pylori can be used as stool biomarkers to assist in the diagnosis of H. pylori infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian H. pylori SA chemiluminescent immunoassay against more invasive biopsy tests that are considered to be the “gold standard” (Composite Reference Method). Methods. This prospective multisite study enrolled patients undergoing an esophagogastroduodenoscopy with collection of biopsy and stool specimens. Adult patients (≥22 years) participated in the study from February 2017 to August 2018. Specimens of the stomach were tested by three methods, known as the Composite Reference Method: (1) histological evaluation, (2) culture of the organism, and (3) rapid urease detection test. H. pylori in stool was detected using the automated LIAISON® Meridian H. pylori SA assay, a chemiluminescent immunoassay. Statistical analyses were performed using MedCalc 18.11.6. Results. 277 patients (63% female) were included in the study. The prevalence of infected subjects was 24.2% in this study cohort. Clinical performance assessed against the Composite Reference Method showed very good agreement (Cohen’s kappa=0.922), with good sensitivity (95.5%) and specificity (97.6%). Reproducibility study results showed total imprecision ranging from 3.1% to 13.9% CV. Conclusion. The automated LIAISON® Meridian H. pylori SA assay brings reliable noninvasive testing for H. pylori to the laboratory that is in very good agreement with the current, more invasive biopsy-based methods such as histology, culture, or rapid urease test. The clinical trial identifiers are NCT03060746 (pretherapy) and NCT03060733 (posttherapy).

Bacterial resistance toward the most used antibiotics is increasing in Helicobacter pylori strains worldwide. Emergence of multidrug resistance significantly affects the efficacy of standard therapy regimens. Therefore, monitoring for primary antimicrobial resistance is essential for H. pylori management in clinical practice.H. pylori isolates obtained from patients consecutively observed in a single center were tested for primary resistance by using E-test method. Bacterial strains showing MIC values 0.5, 8 and 1 mg/L toward clarithromycin, metronidazole and levofloxacin, respectively, were considered resistant. The trend of antibiotic prevalence, either single or combined, during 2010-2016 was assessed.Antibiotic susceptibility data were available in 1424 (82.3%) out of 1730 tested patients. The overall resistance for all the three antibiotics showed an increasing trend from 2010 to 2013 (clarithromycin: from 19% to 35.6%; metronidazole: from 33.6% to 45.3%; levofloxacin: from 19% to 29.7%; p .001), when a plateau until 2016 was observed (clarithromycin: 35.9%; metronidazole: 40.2%; levofloxacin: 29.3%). A similar trend occurred for clarithromycin-metronidazole combined resistance rate (2010: 11.4%; 2013: 28.2%; 2016: 21.9%).Our data suggest that prevalence of primary resistance in H. pylori isolates toward the most frequently used antibiotics probably reached a plateau in the last years.

Background The increasing prevalence of strains resistant to antimicrobial agents is a critical issue in the management of Helicobacter pylori (H. pylori) infection. Aims (1) To evaluate the prevalence of primary resistance to clarithromycin, metronidazole and levofloxacin (2) to assess the effectiveness of sequential therapy on resistant strains (3) to identify the minimum number of subjects to enrol for evaluating the effectiveness of an eradication regimen in patients harbouring resistant strains. Methods Consecutive 1682 treatment naive H. pylori-positive patients referred for upper GI endoscopy between 2010 and 2015 were studied and resistances assessed by E-test. Sequential therapy was offered, effectiveness evaluated and analysed. Results H. pylori-primary resistance to antimicrobials tested was high, and increased between 2010 and 2015. Eradication rates were (estimates and 95% CIs): 97.3% (95.6-98.4) in strains susceptible to clarithromycin and metronidazole; 96.1% (91.7-98.2) in strains resistant to metronidazole but susceptible to clarithromycin; 93.4% (88.2-96.4) in strains resistant to clarithromycin but susceptible to metronidazole; 83.1% (77.7-87.3) in strains resistant to clarithromycin and metronidazole. For any treatment with a 75%-85% eradication rate, some 98-144 patients with resistant strains need to be studied to get reliable information on effectiveness in these patients. Conclusions H. pylori-primary resistance is increasing and represents the most critical factor affecting effectiveness. Sequential therapy eradicated 83% of strains resistant to clarithromycin and metronidazole. Reliable estimates of the effectiveness of a given regimen in patients harbouring resistant strains can be obtained only by assessing a large number of strains.

INTRODUCTION:: Eradicating Helicobacter pylori continues to be a challenge, and no treatment regimen is uniformly successful in all treated patients. Triple therapy with rifabutin and amoxicillin is a successful rescue therapy after consecutive treatment failures. We designed this study to test the efficacy of 12-day rifabutin-based triple therapy in patients infected with multidrug-resistant strains. METHODS:: Consecutive patients with dyspeptic symptoms after at least 1 antibiotic therapy course for H. pylori infection harboring triple-resistant (clarithromycin, metronidazole, levofloxacin) strains were enrolled. They received triple therapy with esomeprazole 40 mg bid, amoxicillin 1 g bid, and rifabutin 150 mg od for 12 days. Patients who failed rifabutin therapy were treated empirically on the basis of the judgment of the treating physician. RESULTS:: A total of 254 out of 756 tested patients were found to be infected with a triple-resistant H. pylori strains after at least 1 antibiotic therapy course. Overall, the infection was eradicated in 213 patients, corresponding to a cure rate of 82.9% (95% CI, 78.3-87.5) by intention-to-treat analysis and 88.7% (95% CI, 84.7-92.7) at per-protocol analysis. In multivariate analysis, no factor was identified as an independent predictor of bacterial eradication. CONCLUSIONS:: There is no current standard for the growing population of patients with multidrug-resistant strains of H. pylori. The 12-day low-dose rifabutin/high-dose proton pump inhibitor regimen is a safe and reliable option for patients infected with triple-resistant strains.

Background and aims: the increasing prevalence of strains resistant to antimicrobial agents is a critical issue for the management of Helicobacter pylori infection. This study aimed to evaluate, in Italian na&iuml, ve patients, H. pylori antibiotic resistance trends and their potential predictive factors during the last decade. Methods: consecutive Italian na&iuml, ve H. pylori positive patients, referred from General Practitioners to our Unit from January 2009 to January 2019 to perform an upper gastrointestinal endoscopy (UGIE), were considered. Each patient underwent 13C-urea breath test (13C-UBT) and UGIE with multiple biopsies to perform rapid urease test (RUT), culture/susceptibility test (vs. clarithromycin, metronidazole, levofloxacin), and histopathological examination. H. pylori status was assessed through CRM (composite reference method: at least two tests positive or only culture positive). Results: between 2009 and 2014, 1763 patients were diagnosed as H. pylori positive, 907 were na&iuml, ve with antibiogram available. Between 2015 and 2019, 1415 patients were diagnosed as H. pylori positive, antibiotic susceptibility test was available in 739 na&iuml, ve patients. H. pylori primary antibiotic resistance rates in the first and second five-year period were, respectively, clarithromycin 30.2% (95% CI 27.2&ndash, 33.3), 37.8% (95% CI 34.2&ndash, 41.4), metronidazole 33.3% (95% CI 30.2&ndash, 36.5), 33.6% (95% CI 30.2&ndash, 37.1), levofloxacin 25.6% (95% CI 22.8&ndash, 28.5), 33.8% (95% CI 37.4&ndash, 47.4), double resistance clarithromycin-metronidazole 18.9% (95% CI 16.4&ndash, 21.6), 20.7% (95% CI 17.8&ndash, 23.8). The increase of the resistance rates to clarithromycin and levofloxacin in na&iuml, ve patients was statistically significant (p &lt, 0.05). Although eradication rates for sequential therapy in the 10 years considered were 93.4% (95% CI 92&ndash, 94.6) and 87.5% (95% CI 85.7&ndash, 89) at per-protocol (PP) and intention-to-treat (ITT) analysis, respectively, they showed a significant decrease in the second five-year period. Conclusions: this data highlights an increase in primary H. pylori antibiotic resistance and strongly suggests the importance of drug susceptibility testing also in na&iuml, ve patients.

Objectives Antimicrobial resistance to clarithromycin and metronidazole significantly affects the cure rate of standard therapies for Helicobacter pylori infection. We tested whether different MIC levels of resistance to these antibiotics play a role in therapeutic efficacy. Methods This was a post hoc analysis of data from a therapeutic trial in which patients with antibiotic susceptibility testing (Etest) received first-line sequential therapy. The level of antibiotic resistance was classified according to MIC values into low (MIC from >0.5 to ≤8 for clarithromycin, and from >8 to ≤32 for metronidazole) and high (MIC from >8 to 256 mg/L for clarithromycin, and from >32 to 256 mg/L for metronidazole). Results Data from 1006 patients were included. There were 520 (51.7%) patients with susceptible strains, 136 (13.5%) with clarithromycin-resistant strains, 144 (14.3%) with metronidazole-resistant strains and 206 (20.5%) with clarithromycin-resistant and metronidazole-resistant strains. In the presence of double resistance, the cure rate was still high (38/41, 92.7%) when MIC levels were low and it was reduced (94/112, 83.9%) only when MIC levels of both antibiotics were high. The cure rates did not significantly differ between patients with single antibiotic-resistant strains, irrespective of MIC values, and those with susceptible strains. Conclusions We found that MIC levels of resistance to either clarithromycin or metronidazole play a role in H. pylori therapy outcome and that bacterial resistance becomes relevant in vivo when clarithromycin-resistant and metronidazole-resistant strains have high MIC values for at least one of these antibiotics.

L’infezione da Helicobacter pylori interessa più della metà della popolazione mondiale ed è la principale causa di ulcera peptica, gastrite cronica e cancro gastrico. Test diagnostici accurati sono necessari per rilevare la presenza dell’infezione e determinare il corretto management pre- e post-eradicazione. Tutti i test utilizzati presentano differenti sensibilità e specificità, per questo motivo le Linee Guida Europee raccomandano l’utilizzo di almeno due test. Questi ultimi si dividono in invasivi (endoscopia con biopsia, relativo esame istologico, colturale e test rapido all’ureasi su campione bioptico) e non invasivi (urea breath test, test fecale e sierologia). L’utilizzo di metodiche invasive è limitato a pazienti selezionati, nei quali l’esame endoscopico si impone per la presenza di sintomi di allarme. Per diagnosticare l’infezione in maniera non invasiva, le uniche due metodiche che consentono di avere dei valori di sensibilità e specificità > 90% sono rappresentate dal 13C-urea breath test e dalla ricerca dell’antigene fecale con anticorpi monoclonali. Nuovi test diagnostici (come il dosaggio degli anticorpi urinari o la cosiddetta endoscopia chimica) potranno rappresentare promettenti metodiche alternative.

Background and aims Italian guideline suggests 10-day sequential or bismuth-based quadruple therapies for first-line Helicobacter pylori treatment. Comparison between these regimens is lacking. We assessed the efficacy of these therapies in clinical practice and evaluated the role of primary bacterial resistance toward clarithromycin and metronidazole. Patients and methods Consecutive patients with H. pylori infection were enrolled. Bacterial culture with antibiotics susceptibility testing was attempted in all cases. Patients received either a sequential therapy with esomeprazole 40 mg for 10 days plus amoxicillin 1000 mg for the first 5 days followed by clarithromycin 500 mg and tinidazole 500 mg (all twice daily) for the remaining 5 days, or bismuth-based therapy with esomeprazole 20 mg twice daily and Pylera 3 tablets four times daily for 10 days. H. pylori eradication was assessed by using13C-urea breath test. Results A total of 495 patients were enrolled. Following sequential (250 patients) and quadruple (245 patients) therapies, the eradication rate were 92 and 91%, respectively, at intention-to-treat analysis and 96 and 97%, respectively, at per protocol analysis. Overall, the pattern of bacterial resistance did not significantly affect the cure rate, but the presence of clarithromycin and metronidazole dual resistance tended to reduce the success rate of both sequential (84.8 vs. 90.1%; P =0.4) and quadruple (85 vs. 94.1%; P= 0.06) therapies. Adverse events occurred more frequently with the quadruple than with sequential therapy (56.9 vs. 25.8%; P

Current guidelines recommend that all patients with documented H. pylori infection should be treated with an appropriate antibacterial therapy. Clarithromycin-based regimens are commonly used as a first line therapy in H. pylori positive patients, however soon after the introduction of clarithromycin-based therapies, treatment failures associated with resistance to clarithromycin were reported. In this study, we evaluated the feasibility of using a non-invasive sample type, stool, to detect the presence of H. pylori by molecular methods while concurrently detecting mutations associated with the resistance to clarithromycin. The sensitivity for H. pylori detection by PCR was 93.8% compared to composite reference methods with gastric tissue biopsy. Out of 213 true positives that were sequenced, 36.2% showed point mutations associated with CLA resistance (A2142C, A2142G, A2143G). The correlation of sequencing and PCR was 98%. The correlation of sequencing and eradication of the infection was 86%. The results of this test may be used as a tool for guiding treatment of H. pylori infection.

Clarithromycin-based regimens are commonly used as a first-line therapy for Helicobacter pylori -positive patients; however, resistance to clarithromycin has led to treatment failures. The aim of this study was to evaluate the feasibility of using stool samples to detect the presence of H. pylori DNA while concurrently detecting mutations associated with resistance to clarithromycin. For this purpose, total DNA was extracted from 294 raw stool specimens from H. pylori -positive and -negative patients. TaqMan real-time PCR amplification was used to detect the presence of H. pylori as well as to predict the phenotype of the organism and the related outcome for patients treated with clarithromycin. Clarithromycin resistance was determined upon analysis of the PCR result. Patients were also tested by a urea breath test and were subjected to esophagogastroduodenoscopy, followed by histology, culture, and a rapid urease test, in order to obtain a consensus patient infection status. Of 294 total stool samples, 227 were deemed true positive. The sensitivity of H. pylori detection by PCR was 93.8%. Of 213 true-positive samples that were sequenced, 36.2% showed point mutations associated with clarithromycin resistance (A2142C, A2142G, A2143G). The final correlation of the mutant genotypes as determined by sequencing with the eradication of infection was 86%. We found that Helicobacter pylori DNA can be detected in human stool specimens with high sensitivity and can therefore be used to determine the presence of the bacterium without obtaining a biopsy sample. Moreover, genotypic resistance to clarithromycin can be predicted without obtaining a biopsy sample, facilitating the choice of the right therapeutic approach.

Primary clarithromycin resistance is the main factor affecting the efficacy of Helicobacter pylori therapy. This study aimed: (i) to assess the concordance between phenotypic (culture) and genotypic (real-time PCR) tests in resistant strains; (ii) to search, in the case of disagreement between the methods, for point mutations other than those reported as the most frequent in Europe; and (iii) to compare the MICs associated with the single point mutations. In order to perform real-time PCR, we retrieved biopsies from patients in whom H. pylori infection was successful diagnosed by bacterial culture and clarithromycin resistance was assessed using the Etest. Only patients who had never been previously treated, and with H. pylori strains that were either resistant exclusively to clarithromycin or without any resistance, were included. Biopsies from 82 infected patients were analysed, including 42 strains that were clarithromycin resistant and 40 that were clarithromycin susceptible on culture. On genotypic analysis, at least one of the three most frequently reported point mutations (A2142C, A2142G and A2143G) was detected in only 23 cases (54.8 %), with a concordance between the two methods of 0.67. Novel point mutations (A2115G, G2141A and A2144T) were detected in a further 14 out of 19 discordant cases, increasing the resistance detection rate of PCR to 88 % (P

Helicobacter pylori plays an important role in the pathogenesis of chronic active gastritis, peptic ulcer and gastric mucosa-associated lymphoid tissue-lymphoma, and is also involved in carcinogenesis of the stomach. Since now no current first-line therapy is able to cure the infection in all treated patients. We evaluated data on the most successful therapy regimens—sequential, concomitant and quadruple therapies—and on the standard therapy available for H. pylori eradication. When therapy fails several factors may be involved: we reviewed both bacterial and host factors that can affect the eradication and that can be involved in therapeutic management of the H. pylori infection.

Colorectal cancer (CRC) is a multistep process that involves adenoma–carcinoma sequence. CRC can be prevented by routine screening, which can detect precancerous lesions. The aim of this study is to clarify whether faecal occult blood test (i-FOBT), tumor M2 pyruvate kinase (t-M2-PK), and endocannabinoid system molecules (cannabinoid receptors type 1—CB1, type 2—CB2, and fatty acid amide hydrolase—FAAH) might represent better diagnostic tools, alone or in combination, for an early diagnosis of CRC. An immunochemical FOB test (i-FOBT) and quantitative ELISA stool test for t-M2-PK were performed in 127 consecutive patients during a 12 month period. Endocannabinoid system molecules and t-M2-PK expression were detected by immunostaining in healthy tissues and normal mucosa surrounding adenomatous and cancerous colon lesions. i-FOBT and t-M2-PK combination leads to a better diagnostic accuracy for pre-neoplastic and neoplastic colon lesions. T-M2-PK quantification in stool samples and in biopsy samples (immunostaining) correlates with tumourigenesis stages. CB1 and CB2 are well expressed in healthy tissues, and their expression decreases in the presence of advanced stages of carcinogenesis and disappears in CRC. FAAH signal is well expressed in normal mucosa and low-risk adenoma, and increased in high-risk adenoma and carcinoma adjacent tissues. This study shows that high levels of t-M2-PK in addition to FOBT enhance the power of a CRC screening test. Endocannabinoid system molecule expression correlates with colon carcinogenesis stages. Developing future faecal tests for their quantification must be undertaken to obtain a more accurate early non-invasive diagnosis for CRC.

Rapid diagnostic tools for Helicobacter pylori are important in endoscopy. To assess the accuracy of a new 5-min rapid urease test (UFT300, ABS Cernusco, sul Naviglio, Italy) compared with the 1-h Pyloritek (Serim Laboratories, Elkhart, IN) and the 24-h CLO test (Kimberly- Clark Ballard Medical Products, Roswell, GA), consecutive dyspeptic patients referred to our unit for endoscopy were prospectively studied. All patients underwent a 13C-urea-breath test, histology and the UFT300 (ABS; Cernusco, sul Naviglio, Italy). Two additional rapid urease tests were performed. Patients were deemed infected when both 13C-UBT and histology were positive. Rapid urease tests were read at 1, 5, and 60 min, respectively. Of the 375 enrolled patients, 45.3% were infected with H. pylori. The sensitivity of the new 5-min rapid urease test 300 was 90.3, 94.5, and 96.2% at 1, 5, and 60 min, respectively (specificity 100%). The Pyloritek and the new 5-min rapid urease test were comparable, but the CLO test was not reliable at 5 and 60 min. In conclusion, the new 5-min rapid urease test is comparable to the Pyloritek test, but the CLO test is significantly less sensitive at early time points. Reading the test results at 1 min may increase falsenegative results with decreasing sensitivity.

Summary Background Helicobacter pylori resistance to antibiotics is increasing worldwide, and it reduces the efficacy of therapy. Aim To assess current primary antibiotic resistance in H. pylori strains isolated in Italy. Methods Between June 2004 and June 2006, H. pylori strains were isolated consecutively in the two participating centres (Bologna, northern Italy; Rome, central Italy) from patients never previously treated for the infection. Isolated strains were tested for primary clarithromycin, metronidazole and levofloxacin resistance using as break point the minimal inhibitory concentration ≥1, ≥8 and ≥1 mg/L for the three antibiotics, respectively. Results Overall, 255 H. pylori strains were evaluated. The resistance rate was 16.9% for clarithromycin, 29.4% for metronidazole and 19.1% for levofloxacin. Clarithromycin resistance was significantly higher in non-ulcer dyspepsia than in peptic ulcer patients (19.1% vs. 0%, P = 0.02), metronidazole resistance was higher in foreign than Italian patients (50% vs. 22.9%, P = 0.0004) and levofloxacin resistance was higher in old than younger patients (28.4% vs. 14.4%, P = 0.048). Levofloxacin resistance was also more frequent in those strains with either clarithromycin or metronidazole resistance. Conclusion A very high rate of primary resistance towards the tested antibiotics was detected in our study.