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Biomedical subjects

L Gatta

Publications and source records attributed to L Gatta.

At least 19 recordsLinked to original sources

A 10-day levofloxacin-based triple therapy in patients who have failed two eradication courses.

BACKGROUND: A standard third-line treatment is lacking, and European guidelines recommend performing culture in these patients. However, the use of this procedure as 'routine practice' is definitively not feasible. AIM: To evaluate the eradication rate of a 10-day levofloxacin-based triple therapy in patients who have failed two eradication courses for Helicobacter pylori. METHODS: A total of 151 patients with persistent Helicobacter pylori infection after two treatments were studied. Patients were considered positive if two of three endoscopic tests were positive. Susceptibility testing was also performed. Patients received a standard dose of proton-pump inhibitors twice daily, levofloxacin 250 mg twice daily and amoxicillin 1 g twice daily, for 10 days. Endoscopic follow-up was carried out 4-6 weeks after the end of eradication therapy. RESULTS: About 76% (95% CI: 68.8-82.3), and 85% (95% CI: 77.5-89.7) of patients were eradicated according to intention-to-treat and per-protocol analysis, respectively. Eradication rates of the strains showed as 92% (95% CI: 83.2-96.7) of those resistant to both metronidazole and clarithromycin but susceptible to levofloxacin. CONCLUSIONS: In patients who failed previous regimens, the 10-day levofloxacin-based triple therapy is safe and effective, allowing eradication in almost 80% of the patients.

Amoxicillin↗

High rate of Helicobacter pylori eradication with sequential therapy in elderly patients with peptic ulcer: a prospective controlled study.

BACKGROUND: Helicobacter pylori eradication rates with triple therapies are decreasing, and few data in elderly patients are available. A 10-day sequential regimen succeeded in curing such H. pylori infection in unselected patients. AIM: To compare this sequential regimen and the standard triple therapy for H. pylori eradication in geriatric patients with peptic ulcer. METHODS: Overall, 179 H. pylori-infected patients with peptic ulcer were enrolled (mean age: 69.5 years; range: 65-83). Patients were randomized to 10-day sequential therapy (rabeprazole 20 mg b.d. plus amoxicillin 1 g b.d. for the first 5 days, followed by rabeprazole 20 mg, clarithromycin 500 mg and tinidazole 500 mg, all b.d., for the remaining 5 days) or standard 7-day triple regimen (rabeprazole 20 mg, clarithromycin 500 mg and amoxicillin 1 g, all b.d.). Helicobacter pylori status was assessed by histology and rapid urease test at baseline and 4-6 weeks after completion of treatment. RESULTS: The sequential regimen achieved eradication rates significantly higher in comparison with the standard regimen at both intention-to-treat (94% vs. 80%; P = 0.008) and per-protocol (97% vs. 83%; P = 0.006) analyses. In both treatment groups, compliance to the therapy was high (> 95%), and the rate of mild side-effects was similarly low (< 12%). At repeated upper endoscopy, peptic ulcer lesions were healed in 97% patients, without a statistically significant difference between the sequential regimen and the standard triple therapy. CONCLUSIONS: In elderly patients with peptic ulcer disease, the 10-day sequential treatment regimen achieved significantly higher eradication rates in comparison with standard triple therapy.

2-Pyridinylmethylsulfinylbenzimidazoles↗

A rapid immunochromatographic assay for Helicobacter pylori in stool before and after treatment.

BACKGROUND: Current guidelines recommend non-invasive testing and treatment of young dyspeptic patients without alarm symptoms. AIM: To evaluate the accuracy of a new rapid immunochromatographic stool test to diagnose Helicobacter pylori infection before and after treatment compared with a gold standard. METHODS: Prospective, single-blind study, performed in a tertiary care hospital. A total of 303 consecutive dyspeptic patients underwent endoscopy with multiple biopsies. Infected patients were offered a treatment and invited to come back 4-6 weeks after the end of therapy to repeat the endoscopy. Patients were also asked to provide a stool sample before and after therapy. RESULTS: About 149 patients were H. pylori infected. The sensitivity and specificity before treatment were 91.3 and 93.5%; after treatment 92 and 100%. The likelihood ratios were robust enough to produce significant changes from pretest to post-test probability both in pre-treatment (LR+ = 14, LR- = 0.093) and post-treatment (LR+ = 19.6, LR- = 0.095). CONCLUSIONS: The novel immunochromatographic stool test is fast, easy to perform and provides good differentiation between positive and negative results. It might become a rapid near patients test easily performed in the doctor office.

Antigens, Bacterial↗

Helicobacter pylori infection: anything new should we know?

Over the past year, 2003-4, there have been a number of studies consolidating previous work in relation to pathogenesis of disease, diagnosis and management of Helicobacter pylori. Studies into the pathogenesis of disease have identified the main adhesin of H. pylori as an important virulence marker and as a potential target for therapy. Molecular investigations of both the strain and host variations have identified the action of several of the virulence factors, e.g. cagA, vacA, on disrupting host cell signalling and the consequences in respect of the release of chemokines from the damaged gastric epithelium and the effect on apoptosis. Over the past year, there have been further diagnostic kits developed based on modifications of current technology. Two promising areas of research for diagnosis are the use of host/strain genome polymorphisms as a means of identifying high-risk patients who may develop severe disease and the use of proteomics to identify potential antigens of diagnostic (or therapeutic) use. The three main antibiotics that are used in first-line eradication regimens are clarithromycin, metronidazole and amoxycillin. Of these, metronidazole has the highest prevalence of resistance, followed by clarithromycin; amoxycillin resistance is only rarely reported. The decreasing success of current first-line therapy is the driving force for the development of new antibiotic combinations and a search for novel sources for chemotherapeutic agents and novel therapeutic targets.

Adhesins, Bacterial↗

The clinical role of extracellular bioimpedance tomography (Gastro-Mida(x)) in the diagnosis of colorectal diseases.

AIM: Gastro-Mida(x) is a non-invasive diagnostic medical device which carries out an extracellular bioimpedance tomographic analysis of the colorectal region with a neural technique interpretation using artificial neural networks to diagnose colorectal diseases. The aim of this spontaneous study carried out in various centres in Italy was to train Gastro-Mida(x) to distinguish normal patients from those with colorectal diseases. METHODS: Patients who were referred to the Endoscopy Units of the 20 centres involved in the study to undergo colonoscopy from September 2002 to December 2003 were included in the study. At least 1 day before colonoscopy, patients underwent Gastro-Mida(x). The training of the bioimpedance tomography in this study considered patients negative (normal) when the colorectal endoscopy was normal or revealed only the presence of haemorrhoids. Patients were considered positive in the presence of diverticula (diverticulosis or diverticulitis), polyps, cancer. For positive patients with more than one pathology, neoplastic or preneoplastic lesions were considered more important than the others and the final diagnosis was made in accordance with this rule. RESULTS: Overall, the 20 centres enrolled 947 patients (males/females: 477/470; average age+/-SD: 57.44+/-13.85 years). The specificity registered after training was 80% (95% CI: 76.5-83.1) and sensitivity was 83.89% (95% CI: 79.5-87.4). The sensitivity of bioimpedance tomography in the subgroup of patients with cancer (N=68) was 88.2% (95% CI: 78.4-93.9). As to polyps, sensitivity was calculated as a whole and according to size classification. The sensitivity of bioimpedance tomography in diagnosing patients with polyps was therefore 78.3% (95% CI: 71.9-83.4). However, sensitivity increased to 83.7% (95% CI: 74.1-90.2) and 83% (95% CI: 70.7-90.8) when the bioimpedance tomography's ability to identify patients with at least one polyp > or = 6 mm and > or = 10 mm in size was taken into consideration. CONCLUSIONS: Gastro-Mida(x) has proven to be a simple, reliable and accurate instrument, once training is completed, in the most common colorectal diseases. The device can therefore be proposed for both diagnosis and screening of colorectal diseases.

Adolescent↗

A rapid, low-dose, 13C-urea tablet for the detection of Helicobacter pylori infection before and after treatment.

BACKGROUND: A new urea breath test (UBT) has been described which uses a tablet formulation of 13C-urea with citric acid and allows breath sampling to be performed as early as 10 min after ingestion of the tablet. AIM: To assess the diagnostic accuracy of tablet-based 13C-UBTs (50 and 100 mg 13C-urea) before and after Helicobacter pylori eradication treatment, compared with an endoscopy gold standard and a conventional 13C-UBT (75 mg 13C-urea). METHODS: Two hundred dyspeptic patients underwent endoscopy, followed by tablet-based 13C-UBTs (50 and 100 mg 13C-urea) and a conventional 13C-UBT (75 mg 13C-urea). H. pylori-infected patients were prescribed treatment and asked to return 4-6 weeks after the end of therapy for repeat endoscopy and 13C-UBTs. RESULTS: One hundred and thirteen patients were infected with H. pylori. The sensitivity and specificity of the conventional 13C-UBT were both 100%; the sensitivity and specificity of the 100-mg tablet-based 13C-UBT were 100% and 98.85%, respectively. For the 50-mg tablet-based 13C-UBT, cut-off values of the difference over baseline of between 1.65 and 3.15 provided a sensitivity and specificity of 100%. At follow-up, the sensitivity and specificity of the conventional and 100-mg tablet-based 13C-UBTs were both 100%. For the 50-mg tablet-based 13C-UBT, cut-off values of the difference over baseline of between 1.49 and 1.56 gave a sensitivity and specificity of 100%. CONCLUSIONS: New 10-min 13C-UBTs using tablet formulations of 13C-urea with citric acid are reliable for the assessment of H. pylori status pre- and post-treatment.

Biopsy↗

High eradication rates of Helicobacter pylori with a new sequential treatment.

BACKGROUND: Eradication rates of Helicobacter pylori with standard triple therapy are disappointing, and studies from several countries confirm this poor performance. AIM: To assess the eradication rate of a new sequential treatment regimen compared with conventional triple therapy for the eradication of H. pylori infection. METHODS: One thousand and forty-nine dyspeptic patients were studied prospectively. H. pylori-infected patients were randomized to receive 10-day sequential therapy [rabeprazole (40 mg daily) plus amoxicillin (1 g twice daily) for the first 5 days, followed by rabeprazole (20 mg), clarithromycin (500 mg) and tinidazole (500 mg) twice daily for the remaining 5 days] or standard 7-day therapy [corrected] [rabeprazole (20 mg), clarithromycin (500 mg) and amoxicillin (1 g) twice daily]. H. pylori status was assessed by histology, rapid urease test and 13C-urea breath test at baseline and 6 weeks or more after completion of treatment. RESULTS: Higher eradication rates were found with the sequential regimen compared to the standard regimen (intention-to-treat: 92% vs. 74%, P < 0.0001; per protocol: 95% vs. 77%, P < 0.0001). Higher eradication rates were also seen in patients with peptic ulcer disease and non-ulcer dyspepsia. In both treatments, compliance was similar (> 90%), as was the rate of side-effects, which were mild. CONCLUSIONS: This 10-day sequential treatment regimen achieves high eradication rates in peptic ulcer disease and non-ulcer dyspepsia.

2-Pyridinylmethylsulfinylbenzimidazoles↗

Review article: diagnosis and treatment of Helicobacter: a 2002 updated review.

The year 2002 saw advances on many fronts in the study of Helicobacter and gastroduodenal disease. Several studies have confirmed endoscopy as a valuable management procedure with confirmation of the diagnostic utility of the rapid urease test and the description of a new formulation of the test, which is more rapid in giving a result. Serology has been re-confirmed as a useful investigation in selected populations. Some commercial kits for near patient testing have also been assessed and although generally regarded as less accurate than laboratory based tests some have shown acceptable accuracy. The recent exciting development in diagnostic serology is the availability of the faecal antigen test; further studies have confirmed its usefulness as recommended screening tests. There have been several studies demonstrating that a test and treat policy has a significant patient benefit, both economic and medical, although there is some doubt if eradication of Helicobacter leads to regression of atrophy and metaplasia. However, in low Helicobacter-prevalence areas the test and treat policy is being challenged as an effective management strategy. Further studies have shown that compliance with treatment regimens is an important determinant of successful eradication. Finally several new eradication regimens have been reported particularly for use in patients who have had previous unsuccessful eradication attempts.

Biopsy↗

Non-invasive techniques for the diagnosis of Helicobacter pylori infection.

Helicobacter pylori infection can be diagnosed by invasive techniques requiring endoscopy and biopsy (histologic examination, culture, polymerase chain reaction), and non-invasive techniques (serology, urea breath test, urine or blood, detection of H. pylori antigen in stool specimen). However, recent studies have demonstrated that a strategy of 'testing and treating' for H. pylori in uninvestigated, young (<50 years), dyspeptic patients in primary care is safe and reduces the need for endoscopy. Indeed, a number of clinical guidelines recommend non-invasive testing in dyspeptic patients followed by treatment of H. pylori in primary care based on clinical and economic analyses. Several non-invasive tests are currently available on the market. The choice depends on the clinical circumstances, the likelihood ratio of positive and negative tests, the cost-effectiveness of the testing strategy, and, finally, the availability of the tests. Nevertheless, two non-invasive tests are commonly used: the urea breath test, and the stool antigen test.

Bacterial Typing Techniques↗

Setting up a quality assurance program in endoscopy.

BACKGROUND: Both patients and government demand proof of quality of care and value for money. Our unit ist in a large teaching hospital, performing over 6000 procedures per year. We have designed and implemented a Quality Assurance (QA) program, the basis of which we believe could be a model for endoscopy QA. METHODS: A QA team was formed and a literature search undertaken. An initial 3 month audit was then performed into indications for, and complications of, all procedures. The results of this initial audit led us to concentrate on colonoscopy and ERCP. The specific items of data collected were based on the "Core Quality Indicators" developed by the American Society for Gastrointestinal Endoscopy (ASGE). We also analysed data relating to endoscope disinfection, equipment failure and carried out a patient satisfaction survey. The data were presented at 3-monthly QA meeting, and appropriate action taken. RESULT: We performed a detailed audit of ERCP (217 procedures) and colonoscopy (904 procedures). Patients risk was stratified using the American Society of Anaesthesiology (ASA) classification. Using these data we established our technical success and complication rates for colonoscopy and ERCP. Audit of equipment revealed that on average an endoscope was away for repair 9 % of the time. Contamination of endoscopes was frequent with glutaraldehyde disinfection; the rate of contamination fell dramatically when we changed our disinfection method. CONCLUSION: A QA program can be implemented in busy endoscopy units. There are significant problems, however, in ensuring that such a program is effective: these include inadequate funding/staffing, lack of suitable information technology and lack of clear guidelines for dealing with poor performance.

Endoscopy↗

Best cut-off values for [14C]-urea breath tests for Helicobacter pylori detection.

BACKGROUND: The 'test and treat' strategy for Helicobacter pylori is recommended in dyspeptic patients under 55 years of age with no alarm symptoms. Reliable non-invasive tests are therefore needed. The aim of this study was to assess the pre- and post-treatment accuracy of a low dose (1 microCi [37kBq]), short collecting time [14C]-UBT (urea breath test) in diagnosing H pylori infection, examining different methods to analyse the best cut-off points. METHODS: The study included 119 patients. Endoscopy and [14C]-UBT were performed in the pre- and post-treatment setting. [14C]-UBT results were expressed in three different ways: 1) the measured disintegrations per minute (dpm) at sample time, 2) the difference (D) in dpm between sample time and the dpm at T0, 3) the ratio of dpm at sample time to dpm at T0. RESULTS: Seventy-six out of the 119 patients (63.9%; 95% CI: 54.9 to 71.9) were infected. Seventy-three (96%) patients completed the follow-up. The most accurate results in both pre- (sensitivity 95.9%; specificity 97.7%) and post-treatment (sensitivity 90.9%; specificity 100%) were obtained using the difference (D) in dpm between sample time at T0 and at T12.5. CONCLUSION: A low dose [14C]-UBT, with a short collecting time, is a reliable method to evaluate H. pylori infection in both the pre- and post-treatment setting.

Adult↗

The clinical role of cytochrome p450 genotypes in Helicobacter pylori management.

OBJECTIVE: The aim of this pharmacogenomics study was to investigate the influence of different cytochrome P450 (CYP) genotypes in Helicobacter pylori eradication therapy. METHOD: The study involved 143 consecutive Italian Caucasian patients with H. pylori infection diagnosed and treated with 1-wk triple therapy according to European Helicobacter Pylori Study Group guidelines. Using human genomic DNA, CYP2C19 (*2 and *3) and CYP3A4 alleles (*1B, *2, and *3) were evaluated by polymerase chain reaction-restriction fragment length polymorphism assays and confirmed by sequencing the amplicons. RESULT: According to the endoscopy-based gold standard, 93 patients achieved H. pylori eradication. Regarding CYP2C19 genotype, the 50 patients who remained infected were all homozygous or heterozygous extensive metabolizers (homEM or hetEM). Carriers of homEM fared significantly less well than those of hetEM; homEM genotype was also predictive of failure at univariate/multivariate analysis. Carriers of CYP3A4 polymorphisms achieved favorable eradication rates similar to patients bearing CYP2C19. All four patients with single CYP3A4*2 polymorphism achieved eradication, and only 29% (5/17) of all CYP3A4*1B carriers did not achieve eradication. All nine patients carrying CYP3A4 polymorphisms in the CYP2C19 hetEM subgroup were cured, suggesting the possibility of a positive synergism between CYP3A4 and CYP2C19. CONCLUSIONS: This first pharmacogenomics study on the influence of different CYP genotypes on H. pylori therapy suggests that, as in Asian populations, CYP2C19 genotype patterns are probably also relevant in Caucasians receiving H. pylori eradication regimens that include omeprazole. The possibility of a favorable drug interaction mediated by CYP2C19 and CYP3A4 requires investigation.

Adult↗

Effect of Helicobacter pylori eradication on development of dyspeptic and reflux disease in healthy asymptomatic subjects.

BACKGROUND AND AIM: There are few data on the course of Helicobacter pylori infection in asymptomatic subjects. The aim of this study was to assess the effect of eradication therapy on the development of dyspeptic and gastro-oesophageal reflux disease in a cohort of asymptomatic individuals observed over a prolonged period. METHODS: A total of 169 blood donors infected with H pylori who had volunteered for studies on eradication in 1990 formed the cohort. To be included in this cohort subjects had to have no symptoms, as determined by a validated symptom questionnaire at the baseline visit. Eighty eight subjects were infected with H pylori while 81 had successfully undergone eradication therapy. Subjects were followed up (annually) using the same symptom questionnaire and in 2000 they underwent repeat endoscopy. RESULTS: Thirteen subjects developed symptoms during follow up. The incidence of symptoms in H pylori positive subjects was 1.893/100 person-years of follow up and in H pylori negative individuals 0.163/100 person-years of follow up. H pylori infected subjects were significantly more likely to develop symptoms (log rank test, p=0.003) as well as those infected with CagA positive strains (log rank test, p=0.017). The development of symptomatic gastro-oesophageal reflux disease was no different in individuals with and without eradication (odds ratio 0.57 (95% confidence interval 0.26-1.24); p=0.163). CONCLUSIONS: H pylori eradication prevents the development of dyspeptic symptoms and peptic ulcer disease in healthy asymptomatic blood donors and is not associated with an increase in the incidence of symptomatic gastro-oesophageal reflux disease.

Antibodies, Bacterial↗

Review article: Helicobacter pylori infection from pathogenesis to treatment--a critical reappraisal.

The main areas of this review are Helicobacter pylori and disease pathogenesis; the relationship of H. pylori to lower gastrointestinal diseases, liver disease and extra-gastrointestinal conditions; the relationship of H. pylori to gastro-oesophageal reflux disease; infection in the very young and very old; diagnostic techniques; and management of H. pylori infections with particular emphasis on eradication regimens and antibiotic resistance.

Adult↗

Helicobacter pylori infection, anti-cagA antibodies and peptic ulcer: a case-control study in Italy.

AIM: To evaluate the association between infection with specific strains of Helicobacter pylori and peptic ulcer in patients referred for upper gastrointestinal endoscopy. METHODS: One thousand, six hundred and twenty-six consecutive dyspeptic patients, referred to one Endoscopy Unit in Bologna, Italy, were enrolled. For each participant, a blood sample was obtained for the measurement of distinct immunoglobulin G antibodies against H. pylori lysate and cytotoxin associated gene A (cagA). A case-control study included the whole series: patients diagnosed with duodenal (n=275) or gastric (n=71) ulcer were identified and independently compared with controls with non-ulcer dyspepsia (n=1280). RESULTS: H. pylori seroprevalence (at least one positive marker) was associated with increasing age, male sex and a diagnosis of peptic ulcer. This association was stronger with duodenal ulcer (multivariate odds ratio (OR), 5.2; 95% confidence interval (CI), 3.5-7.9) than with gastric ulcer (OR, 2.3; 95% CI, 1.2-4.4). Further analyses showed that H. pylori lysate+/cagA- subjects had a moderately increased risk of duodenal (OR, 3.2), but not gastric (OR, 1.1), ulcer. When cagA+ subjects were separately compared with seronegative patients, there was a six-fold increased risk for duodenal ulcer and a three-fold increased risk for gastric ulcer. CONCLUSIONS: A strong positive association between infection with a cagA+ H. pylori strain and the presence of peptic disease was found. The seroprevalence of anti-cagA antibodies among patients with non-ulcer dyspepsia is so high (41%) to preclude its use as a pre-endoscopic screening test.

Adult↗

Review article: diagnosis of Helicobacter pylori infection.

Helicobacter pylori (H. pylori) infection can be diagnosed by invasive techniques requiring endoscopy and biopsy (histological examination, culture, polymerase chain reaction) and by noninvasive techniques (serology, urea breath test, urine or blood, detection of H. pylori antigen in stool specimen). At present, no single test can be absolutely relied upon to detect colonization by H. pylori, and a combination of two tests is recommended if feasible. The tests used should depend on the clinical circumstances, the likelihood ratio of positive and negative tests, the cost-effectiveness of the testing strategy, and the availability of the tests. Some clinical circumstances warrant invasive studies, principally patients with alarm symptoms (bleeding, weight loss, etc.) as well as older patients with new-onset dyspepsia. Endoscopy may also be advisable in patients who have failed eradication therapy and need culture and antimicrobial sensitivity testing to determine an appropriate regimen. Recent studies have also demonstrated that a strategy to 'test and treat' for H. pylori in uninvestigated, young (< 50 years), dyspeptic patients in primary care is safe and reduces the need for endoscopy. Indeed, a number of clinical guidelines recommend noninvasive testing followed by treatment of H. pylori for dyspeptic patients in primary care based on clinical and economic analyses.

Biopsy↗