Twice-a-day PPI, tetracycline, metronidazole quadruple therapy with Pylera® or Lactobacillus reuteri for treatment naïve or for retreatment of Helicobacter pylori. Two randomized pilot studies.

BACKGROUND: Bismuth is no longer available in Europe except as part of combination therapy. Lactobacillus reuteri has also been used as an adjuvant for Helicobacter pylori therapy. We aimed to investigate the efficacy of a b.i.d. quadruple therapy containing Pylera® or L reuteri for H pylori infection. MATERIALS AND METHODS: We performed two open-label randomized pilot studies. Adult patients positive for H pylori were randomly assigned to b.i.d therapy with quadruple therapy containing bismuth (2 capsules of Pylera® plus 250 mg each of tetracycline and metronidazole for a total of 500 mg of each), or the same dose of antibiotics plus 2 × 108  CFU L reuteri DSM 17 938 plus 2 × 108  CFU L reuteri ATCC PTA 6475 (Gastrus®) once daily and pantoprazole 20 mg b.i.d. Regimens were given with meals for 10 days. Cure was defined by negative 13C-UBT or stool antigen test. RESULTS: A total of 99 subjects (29% men) were enrolled; 92 completed the study. In the Pylera® group, H pylori infection was cured in 95.7%; 95% CI = 85%-99% (44/46) PP and 88%; 95% CI = 75%-95% (44/50) ITT vs. 84.8%; 95% CI = 71%-95% (39/46) PP and 79.6%; 95% CI = 65%-89% (39/49) ITT in the Gastrus® group, respectively. Cure rates in naїve patients were 100%; 95% CI = 85%-100% (25/25) PP with Pylera®, and 89.7%; 95% CI = 72%-97% (26/29) with Gastrus®. Compliance was excellent and side effects mild with both regimens. CONCLUSIONS: B.i.d. bismuth quadruple therapy was highly effective for H pylori eradication in treatment of naïve patients in Sardinia. Replacement of bismuth with Gastrus® might be considered when bismuth is contraindicated or unavailable.

Risk factors for erosive and non-erosive gastroesophageal reflux disease and Barrett's esophagus in Nothern Sardinia.

OBJECTIVE: Gastroesophageal reflux disease (GERD) and esophageal adenocarcinoma have been increasing. We studied the relationship of conventional risk factors and Helicobacter pylori infection in patients with erosive and non-erosive GERD and Barrett's esophagus. MATERIALS AND METHODS: This was a retrospective study of dyspeptic patients undergoing upper endoscopy between 2002 and 2013. Following endoscopy, those with previously undiagnosed GERD were sub-grouped into non-erosive GERD (NERD), erosive GERD (eGERD), or Barrett's esophagus. H. pylori status was confirmed by 2 positive tests. RESULTS: About 5156 patients were included, GERD was present in 65.6% including 1992 with NERD and 1392 with eGERD. About 1772 dyspeptic patients without symptoms of reflux and/or esophagitis served as controls. A hiatal hernia increased the risk of both eGERD and NERD. eGERD was more prevalent among the obese (OR =1.72, p < 0.001), men (OR =1.38, p < 0.001) and current smokers. Helicobacter pylori infection was significantly more common among those with NERD (OR =1.17 versus 1.01, p = 0.046). Logistic regression analysis for eGERD and NERD using age, gender, body mass index, H. pylori infection, hiatal hernia, and smoking showed that overweight and hiatal hernia were significant risk factors for eGERD, and female gender for NERD. Male gender, eGERD and age >50 years were the major risk factors for Barrett's esophagus. CONCLUSIONS: The epidemiology of eGERD and NERD suggests differences in pathogenesis, and prevention and treatment strategies should be separately examined in men and women.

Cherry-tree colon: colonoscopic appearance suggesting drug-induced mucosal injury.

Drug-induced damage to the gastrointestinal mucosa has been mainly focused on damage in the upper tract. However, increasing evidence suggests that commonly used drugs may also affect the mucosa of the lower gut, and particularly in the colon. The aim of this study was to report that fairly homogeneous colonoscopic findings, correlate with histological evidence of drug-induced mucosal injury. Charts of patients with the "cherry tree" colonoscopic aspect were reviewed to correlate the endoscopic and histological findings for a possible association with the use of drugs. Data from 29 patients (5 men, 24 women, age range 16-76 years) with the "cherry tree" colonoscopic findings were analyzed. Histology revealed an increase in eosinophils in the left colon in 23 patients, pseudomelanosis coli in 3, and microscopic colitis in 3. The findings were associated with proton pump inhibitors in 19 (65.5 %), non-steroidal anti-inflammatory drugs or statins (3 cases each), and other drugs [4 cases, including estroprogestinics (1), antidepressants (2), and thyroxin (1)]. The "cherry tree" colonoscopic appearance suggests drug-induced colonic damage. Awareness of this association may prevent unnecessary, expensive and time-consuming procedures.

Lactobacillus reuteri in the treatment of Helicobacter pylori infection.

Probiotics have proven to be useful in the treatment of a number of gastrointestinal diseases. Probiotics may compete directly with Helicobacter pylori, possibly by interference with adherence or by the production of antimicrobial molecules. Lactobacillus reuteri has been shown to inhibit H. pylori in vitro and in vivo, and theoretically may play a role in eradication therapy. The aim of this study was to examine the efficacy of L. reuteri in H. pylori eradication therapy. This was an open label single center study. H. pylori infection was defined as positive gastric histopathology and (13)C-UBT. Intervention consisted of L. reuteri (DSM 17938) 10(8) cfu plus pantoprazole 20 mg twice a day for 8 weeks. Eradication was defined as a negative (13)C-UBT, 4-6 weeks post therapy. Compliance was considered good if at least 90% of the total number of the pills were taken. 21 of 22 subjects completed the study without protocol violation (mean age 52 years; 36% men). L. reuteri plus pantoprazole twice a day cured 13.6% (3/22; 95% CI 2.9-34.9%) of patients with H. pylori infection by ITT analysis and 14.2% (3/21; 95% CI 3.0-36%) by PP analysis. Overall urease activity assessed before and 4-6 weeks post therapy showed a significant reduction with a difference of mean of 38.8 vs. 25.4 by one-tailed test (P = 0.002). In conclusion, L. reuteri may have a potential role in H. pylori eradication therapy if the cure rate can be improved by changes in dose, dosing interval, or duration of therapy.

Detection of clarithromycin resistance in Helicobacter pylori following noncryogenic storage of rapid urease tests for 30 days.

OBJECTIVE: Traditional Helicobacter pylori (H. pylori) eradication therapy has been undermined by increasing antimicrobial, especially clarithromycin, resistance. Susceptibility testing in some areas is difficult to achieve or unavailable. We aimed to determine whether gastric biopsy specimens stored at room temperature for rapid urease test (RUT) were suitable for clarithromycin susceptibility testing of H. pylori. METHODS: After 30 days of storage at room temperature, DNA was extracted from gastric biopsies present in RUTs (Hpfast). H. pylori status and clarithromycin susceptibility were evaluated using H. pylori-specific polymerase chain reaction (PCR) for ureA, vacA, and allele-specific primer-PCR of the 23S rRNA genes. The PCR results were compared with histology, RUT, and culture results. H. pylori positive was defined as RUT and either culture or histology positive; H. pylori negative as RUT, culture and histology negative. RESULTS: Samples from 31 patients were evaluated; 11 were H. pylori positive including 9 by culture; seven of which had allele-specific primer-PCR results from the RUT specimen for the detection of mutations of the 23S rRNA gene. When both tests were available, culture and PCR results were concordant in 7 cases. In 15 of the 20 histology, RUT and culture negative patients, three PCR were negative. In one patient, all of the three tests were positive; and in three only the 23S rRNA was positive and in one only ureA was positive. CONCLUSION: Gastric biopsy specimens stored in the gel of RUT for 30 days can be used for molecular testing to confirm the diagnosis of H. pylori infection and test for clarithromycin susceptibility.

Clinical practice: diagnosis and evaluation of dyspepsia.

The main issue regarding the approach to the patient with uninvestigated dyspepsia is whether the symptoms are the result of an important clinical illness, which then determines the appropriate management strategy for the treatment of the symptoms. An initial trial of empiric antisecretory drugs is recommended for those without Helicobacter pylori infection and no alarm symptoms, whereas H. pylori eradication is recommended for those with an active H. pylori infection. Treatment expectations for H. pylori infections should theoretically be similar to other common infectious diseases. In most regions, clarithromycin resistance has undermined traditional triple therapy so that it is no longer a suitable choice as an empiric therapy. Four drug therapies, such as sequential, concomitant, and bismuth-quadruple therapy are generally still acceptable choices as empiric therapies. Posteradication testing is highly recommended to provide early identification of otherwise unrecognized increasing antimicrobial resistance. However, despite the ability to successfully cure H. pylori infections, a symptomatic response can be expected in only a minority of those with dyspepsia not associated with ulcers (so called nonulcer dyspepsia). Overall, from the patients stand point, symptomatic relief is often difficult to achieve and physicians must rely on reassurance along with empiric and individualized care.