Michele Caselli

Evaluation of a new enzyme immunoassay for detecting Helicobacter pylori in feces : a prospective pilot study

OBJECTIVES:There is an increasing interest in noninvasive tests for detecting Helicobacter pylori (H. pylori) infection. Unlike serological and urea breath tests, the possibility of searching for H. pylori in feces has been scarcely investigated. The aim of this prospective pilot study was to evaluate the usefulness of a new enzyme immunoassay for detecting H. pylori antigens in feces, as a predictor of H. pylori status in the pre- and posttreatment settings.METHODS:One hundred and fifty-four symptomatic, anti-H. pylori untreated patients (Group A) and 116 anti-H. pylori treated patients (Group B) underwent gastroscopy with biopsies of the antrum and corpus for histology (H) and rapid urease test (RUT). In the anti-H. pylori treated group, a 13C-urea breath test (UBT) was also performed. In Group A, H. pylori status was defined as positive or negative when both H and RUT gave concordant positive or negative results. In Group B, the patients were considered eradicated if all three tests were negative. A stool specimen was collected from all patients the day after gastroscopy, and tested by using an enzyme immunoassay commercial kit for detecting H. pylori antigens in feces (HpSAT).RESULTS:Eighty-five patients in Group A (55%) and 44 in Group B (38%) were H. pylori infected. On the whole, HpSAT showed a sensitivity of 94% and specificity of 86%. In Group A and Group B, sensitivity and specificity were 94%versus 93%, and 90%versus 82%, respectively (p < 0.05).CONCLUSIONS:HpSAT seems to be a reliable method for predicting H. pylori status in anti-H. pylori untreated patients. Conversely, the test appears less suitable to evaluate the outcome of the eradicating treatment. Consequently, it is likely to be accepted for the primary diagnosis of H. pylori status, particularly in dyspeptic young patients.

Campylobacter-Like Organisms, Nonsteroidal Anti-Inflammatory Drugs and Gastric Lesions in Patients with Rheumatoid Arthritis

A histological study was performed in order to evaluate the prevalence of Campylobacter-like organisms (CLO) and gastric antral lesions in 85 rheumatoid arthritis (RA) patients using NSAIDs, and in 100 nonrheumatoid outpatients comparable in terms of sex and age, not using NSAIDs. Histological evidence of gastritis was a common finding both in RA patients (88.2%) and in nonrheumatoid outpatients (89.0%). On the other hand, CLO were detected in a significantly lower proportion (p less than 0.001) of RA patients than outpatients (30.6 and 59.0%, respectively). Considering each NSAID used separately (aspirin, diclofenac sodium and ketoprofen), no significant difference in the presence of CLO in the three groups was found; in the small group of patients treated with aspirin, however, bacteria were never detected. MICs of each NSAID used against 15 isolates of Campylobacter pylori were also determined.

Helicobacter pylori and chronic bronchitis.

BACKGROUND Chronic infections such as those caused by Helicobacter pylori, Chlamydia pneumoniae, and cytomegalovirus have been epidemiologically related to coronary heart disease (CHD). Other studies place H. pylori in relation to other extradigestive diseases. We carried out an epidemiologic pilot study to evaluate the prevalence of H. pylori in patients with chronic bronchitis, a respiratory disease characterized by persistent chronic inflammation, in comparison with a matched control group. METHODS An enzyme-linked immunosorbent assay IgG test for H. pylori diagnosis was performed in 60 consecutive patients with chronic bronchitis (15 women and 45 men; age range, 50-89 years; mean age, 70.38 years) and in 69 control subjects, well matched for age and social status (19 women and 50 men: age range, 52-90 years; mean age, 71.3 years). RESULTS Foty-nine of 60 patients with chronic bronchitis (81.6%) and 40 of 69 subjects in the control group (57.9%) were H. pylori-positive (P = 0.0079). The odds ratio, calculated by simple analysis (3.2) and confirmed by logistic regression analysis (3.399), indicated that H. pylori infection greatly increases the risk of chronic bronchitis. CONCLUSIONS To date, CHD is the only convincing association between H. pylori infection and an extradigestive disease. The main conclusion of this pilot study is that H. pylori infection seems to increase the risk of developing of chronic bronchitis. An important step in this field will be to evaluate the possible change in the clinical conditions after successful eradication therapy in H. pylori-positive patients with chronic bronchitis.

Short-term low-dose triple therapy with azithromycin, metronidazole and lansoprazole appears highly effective for the eradication of Helicobacter pylori

Background: Although the OCN (omeprazole, clarithromycin and nitroimidazoles) shortterm low‐dose regimens are regarded as ‘the standard’ in the treatment of Helicobacter pylori infection, azithromycin is a new‐generation, acid‐stable macrolide which may prove particularly useful for a new short‐term low‐dose triple therapy regimen. Objective: To further improve OCN eradication treatments by reducing both the number of pills and the total cost. Methods: A new short‐term low‐dose triple therapy (LAM) using lansoprazole 30mg once a day for 1 week, azithromycin 500 mg once a day for 3 days, and metronidazole 250mg twice a day for the same 3 days, was administrated to 60 patients presenting with H. pylori‐positive gastritis with or without peptic ulcer, and compared with the classic ‘Bazzoli regimen’ (OCT: omeprazole, clarithromycin, tinidazole) in 60 matched patients. H. pylori infection before and after therapy was evaluated by a rapid urease test, conventional histology and toluidine‐stained semi‐thin sections. Three biopsies from the corpus and three from the antrum were taken during endoscopical examination before and 7‐8 weeks after discontinuation of the treatment. Patient compliance, drug tolerance and drug costs were also taken into consideration. Results: H. pylori infection was eradicated 7‐8 weeks after treatment in 56 of the 60 patients in the LAM group (93.3%), and in 52 of the 57 patients in the OCT group who completed the treatment (91.2%), with no statistical difference. When gastric or duodenal ulceration was present, ulcer healing was observed in all cases. Conclusion: The new proposed short‐term low‐dose triple therapy (LAM) appears to be as effective as the OCT for the eradication of H. pylori infection. The new treatment, however, seems to have advantages in terms of drug tolerance, patient compliance and therapy cost.

Helicobacter pylori stool antigen test: clinical evaluation and cost analysis of a new enzyme immunoassay.

Noninvasive tests for Helicobacter pylori areincreasingly used. Recently, an enzyme immunoassay forH. pylori detection in feces has been put on the market.Aim of this multicenter study was to evaluate the usefulness of this novel test as apredictor of H. pylori status in the pretreatmentsetting. Three hundred consecutive patients wereenrolled. None of the patients had received anyeradicating treatment in the last 12 months, and all underwentgastroscopy with biopsies of the antrum and body forhistology (H) and rapid urease test (RUT). H. pyloristatus was defined positive (or negative) if both H and RUT were positive (or negative). When H and RUTgave conflicting results, the patients were classifiedas H. pylori indeterminate. A stool specimen wascollected for each patient and tested by using a novel enzyme immunoassay for H. pylori detection(HpSAT). Sensitivity, specificity, and diagnosticaccuracy of the test were calculated, as was the cost ofeach assay. H. pylori status was positive in 159patients, negative in 131, and indeterminate in 10. HpSATgave evaluable results (positive or negative) in 293patients, and doubtful results in 7 (2.3%). Sensitivity,specificity, and diagnostic accuracy of HpSAT were 96.8%, 89.7%, and 93.6% respectively.Considering the H. pylori-indeterminate patients aspositive, the percentages were 95.8%, 98.7%, and 93.2%respectively. The cost for each assay was about US

Actual concept of "probiotics": Is it more functional to science or business?

27. These results suggest that HpSAT is anoninvasive, simple, reliable, fast, and cheap methodfor evaluating H. pylori status in the pretreatmentsetting.

A Four-Day Low Dose Triple Therapy Regimen for the Treatment of Helicobacter pylori Infection

It is our contention that the concept of a probiotic as a living bacterium providing unspecified health benefits is inhibiting the development and establishment of an evidence base for the growing field of pharmacobiotics. We believe this is due in part to the current regulatory framework, lack of a clear definition of a probiotic, the ease with which currently defined probiotics can be positioned in the market place, and the enormous profits earned for minimum investment in research. To avoid this, we believe the following two actions are mandatory: international guidelines by a forum of stakeholders made available to scientists and clinicians, patient organizations, and governments; public research funds made available to the scientific community for performing independent rigorous studies both at the preclinical and clinical levels.

Prophylaxis and treatment of NSAID-induced gastroduodenal disorders

Objective:The current guidelines recommend 1-wk triple therapy regimens for eradicating H. pylori infection. Until now, shorter regimens have scarcely been investigated. Azithromycin is a new generation macrolide antibiotic with unusual and favorable pharmacokinetics, and seems to be a very promising agent for innovative anti-H. pylori regimens. We assessed the efficacy and tolerability of a new 4-day low dose triple therapy in comparison with a well established 1-wk triple therapy in the treatment of Helicobacter pylori infection.Methods:One hundred-sixty consecutive patients with biopsy-proven H. pylori infection were randomized to receive lansoprazole 30 mg b.i.d. on days 1–4, azithromycin 500 mg u.i. on days 2–4, and tinidazole 2000 mg u.i.d. on day 3 (LAT group), or 7 days of triple therapy of omeprazole 20 mg u.i.d. clarithromycin 250 mg b.i.d., and tinidazole 500 mg b.i.d. (OCT group). Patients with gastric or duodenal active ulcer received proton pump inhibitors for an additional 4 wk. H. pylori eradication was defined as negative of both rapid urease test and histology on biopsies taken from the gastric body and antrum at least 1 month after the end of treatment.Results:Seven patients in the LAT group and four in the OCT group were lost to follow-up. No significant difference in either efficacy or tolerability was observed between the two regimens. Active ulcers healed in 97.8% of cases with LAT and in 100% of cases with OCT. The eradication rate was 80.8% in the LAT group and 85.5% in the OCT group, considering the per-protocol results, and 73.3% and 81.2%, respectively, considering the intention-to-treat results. Side effects occurred in one LAzT patient and in two OCT patients; they were mild and did not interfere with compliance.Conclusion:The new proposed ultrashort triple therapy, including lansoprazole, low dose azithromycin for 3 days, and a single dose of tinidazole, appears to be a very effective anti-H. pylori regimen, a simpler, cheaper, well-tolerated, and equally effective alternative to 1-wk triple therapy.

Segmented filamentous bacteria-like organisms in histological slides of ileo-cecal valves in patients with ulcerative colitis

A significant percentage of patients taking nonsteroidal anti-inflammatory drugs (NSAIDs) experience some type of adverse gastrointestinal symptoms, lesions of the gastroduodenal tract being clinically the most relevant.NSAIDs cause gastrointestinal damage by 2 independent mechanisms: a topical effect, which is pH and pKa related, and a systemic effect mediated by cyclo-oxygenase (COX) inhibition with a reduction in prostaglandin synthesis. Using endoscopy, gastroduodenal lesions identified include subepithelial haemorrhages, erosions and ulcers. The prevalence of ulceration in NSAID users has been reported as being between 14 and 31% with a 2-fold higher frequency of gastric ulcers compared with duodenal ulcers.Among the strategies used to decrease the risk of ulcer development are: (i) the use of analgesics other than NS AIDs; (ii) use of the lowest possible dosage of NS AID; (iii) the use of a COX-2 selective NS AID; (iv) the use of low doses of corticosteroids instead of NSAIDs; (v) avoidance of concomitant use of NSAIDs and corticosteroids; and (vi) use of preventive therapy.In an attempt to reduce the incidence of NSAID-induced gastrointestinal lesions, the following approaches have been proposed: (i) use of the prostaglandin analogue misoprostol, which is an antiulcer drug which has been proven to be as effective in the prevention of NSAID-induced gastric and duodenal ulcers as in the reduction of serious upper gastrointestinal complications; (ii) histamine H2 receptor antagonists (H2 antagonists), e.g. ranitidine, cimetidine and famotidine, which are useful in the prevention of NSAID-induced duodenal ulcers during long term treatment, but not in the prevention of NSAID-induced gastric ulcers; (iii) proton pump inhibitors, e.g omeprazole, and pantoprazole, whose efficacy in preventing NSAID-associated ulcers has been recently demonstrated; and (iv) barrier agents, e.g. sucralfate, which cannot be recommended as prophylactic agents to prevent NSAID-induced gastropathy.The first step in the treatment of NSAID-associated ulcers lies in a reduction in the dosage of the NSAID or discontinuation of the drug. If NSAID treatment cannot be withdrawn, a proton pump inhibitor appears to be the most effective treatment in healing ulcers, accelerating the slow healing observed with H2 antagonists.

Gastric metaplasia in duodenal bulb andCampylobacter-like organisms in development of duodenal ulcer

Segmented Filamentous Bacteria-Like Organisms in Histological Slides of Ileo-Cecal Valves in Patients with Ulcerative Colitis