Rescue Therapies for Helicobacter pylori Infection in Foreign Patients Treated in Italy.

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.

Rifabutin-Based Triple Therapy Or Bismuth-Based Quadruple Regimen As Rescue Therapies For Helicobacter pylori Infection.

BACKGROUND/AIMS: H. pylori treatment remains a challenge for clinicians, and a definite quote of patients require two or more treatments. We evaluated the efficacy of rifabutin-based therapy and Pylera® regimen as rescue therapies. METHODS: Between January 2016 and December 2019, dyspeptic patients with at least one therapeutic failure observed in clinical practice received either a 12-day rifabutin-based triple therapy (esomeprazole 40 mg and amoxicillin 1 g, both twice daily, and rifabutin 150 mg once daily) or 10-day quadruple therapy with Pylera® (three in one capsule containing 140 mg bismuth subcitrate potassium, 125 mg metronidazole and 125 mg tetracycline). The eradication rates according to previous number of eradication failure therapies were calculated. The role antibiotic resistance pattern in H. pylori isolates was also investigated. RESULTS: Data of 423 patients were available. A total of 270 patients were treated with rifabutin-based therapy, and the overall eradication rate was 61.9%. Pylera® therapy was administered to 153 patients and the cure rate was 88.3%. According to the number of previous therapeutic failures, the eradication rate for the rifabutin-based therapy was 68.3% as second-line and further decreased to 63.1% in fourth-line therapy. Following Pylera® regimen, the cure rate was 94.8% in second-line, and remained 89.6% in fourth-line therapy. Efficacy of rifabutin-based and Pylera® therapies significantly decreased when clarithromycin and levofloxacin resistance, respectively, were present. CONCLUSIONS: Our data documented a decreasing trend for rifabutin-based therapy efficacy according to previous therapy failures, whilst this did not occur for Pylera®.

Antibiotic Resistance and Therapy for H. pylori Infection in Immigrant Patients Treated in Italy.

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.

Antimicrobial Efficacy of Five Probiotic Strains Against Helicobacter pylori.

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.

Efficacy of a new nutraceutical formulation (CHETOGERD®) in patients with nonerosive reflux disease (NERD): a prospective observational study.

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.

Trends in Primary Antibiotic Resistance in H. pylori Strains Isolated in Italy between 2009 and 2019.

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 naïve patients, H. pylori antibiotic resistance trends and their potential predictive factors during the last decade. METHODS: consecutive Italian naïve 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 naïve with antibiogram available. Between 2015 and 2019, 1415 patients were diagnosed as H. pylori positive, antibiotic susceptibility test was available in 739 naïve patients. H. pylori primary antibiotic resistance rates in the first and second five-year period were, respectively, clarithromycin 30.2% (95% CI 27.2-33.3), 37.8% (95% CI 34.2-41.4); metronidazole 33.3% (95% CI 30.2-36.5), 33.6% (95% CI 30.2-37.1); levofloxacin 25.6% (95% CI 22.8-28.5), 33.8% (95% CI 37.4-47.4), double resistance clarithromycin-metronidazole 18.9% (95% CI 16.4-21.6), 20.7% (95% CI 17.8-23.8). The increase of the resistance rates to clarithromycin and levofloxacin in naïve patients was statistically significant (p < 0.05). Although eradication rates for sequential therapy in the 10 years considered were 93.4% (95% CI 92-94.6) and 87.5% (95% CI 85.7-89) 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 naïve patients.