Droplet Digital PCR Detects Low-Density Infection in a Significant Proportion of Helicobacter Pylori-Negative Gastric Biopsies of Dyspeptic Patients.

INTRODUCTION: Helicobacter pylori-infected individuals may present low-density infection, undetectable by conventional tests such as histology, rapid urease test, or urea breath test. Droplet digital polymerase chain reaction (ddPCR) is more sensitive than other polymerase chain reaction methods. We aimed to evaluate the ability of ddPCR to detect H. pylori infection in patients diagnosed as negative by conventional tests. METHODS: Dyspeptic patients (n = 236) were tested for H. pylori by histology, urea breath test, and rapid urease test. Patients were classified as having 3 positive (n = 25, control group), 2 positive (n = 12), one positive (n = 41), or zero positive (n = 158) diagnostic tests. DNA was extracted from gastric biopsies. Triplicate ddPCR testing for each of the 16S rDNA, ureA, and vacA(s) genes was performed using a QX200 ddPCR system (Bio-Rad). A gene was considered positive when detected by at least 2 of 3 repeated ddPCRs. H. pylori positivity was defined as having 2 or more positive genes. RESULTS: All the biopsies of the control patients were positive for all 3 16S rDNA, ureA, and vacA(s) genes. H. pylori infection was detected in 57 (36%), 22 (54%), and 9 (75%) patients with zero, 1, and 2 positive diagnostic tests, respectively. The density of infection was 5, 121, 599, and 3,133 copies of H. pylori genome equivalents for patients with zero, 1, and 2 of 3 positive test results and for the control group, respectively. DISCUSSION: ddPCR detected low-density "occult" H. pylori infection in a significant proportion (36%) of patients diagnosed as negative by conventional methods. The number of conventional positive tests was related to the density of infection.

Adalimumab or Infliximab for the Prevention of Early Postoperative Recurrence of Crohn Disease: Results From the ENEIDA Registry.

BACKGROUND: Anti-tumor necrosis factor agents (anti-TNFs) are efficacious at preventing the postoperative recurrence (POR) of Crohn disease, as demonstrated in 2 randomized controlled trials. However, real-life data for infliximab or adalimumab in this setting are scarce. Our aim was to assess both the efficiency of anti-TNFs at preventing early POR of Crohn disease in clinical practice and the associated risk factors for POR. METHODS: Patients in whom anti-TNFs were prescribed for the prevention of POR within 3 months after ileocolonic resection and who had an endoscopic assessment within 18 months were identified from the ENEIDA registry. Clinical and endoscopic features were collected within 18 months after surgery. RESULTS: In total, 152 patients were included (55 treated with infliximab, 97 with adalimumab, and 39% with concomitant immunosuppressants). Anti-TNF treatment was started after a median time of 29 days (IQR 13-44) after surgery. Eighty-two percent of patients had at least one risk factor for POR, and 82% had been exposed to anti-TNFs before the index surgery. Overall, 34% had endoscopic POR (as defined using a Rutgeerts endoscopic score > i1); 14% had advanced endoscopic POR (>i2); and 20% had clinical POR, with no differences between infliximab and adalimumab. In the multivariate analysis, only perianal disease (odds ratio 2.73, 95% confidence interval [CI] 1.26-5.91) and rectal involvement (odds ratio 2.79, 95% CI 1.09-7.14) were independent predictors of endoscopic POR. CONCLUSIONS: In clinical practice, anti-TNFs for the prevention of POR of Crohn disease are frequently used in patients experienced with anti-TNFs and with concomitant immunosuppressants. The efficacy of infliximab and adalimumab for POR prevention is similar and in accordance with the results obtained in randomized controlled trials.

Relevant Infections in Inflammatory Bowel Disease, and Their Relationship With Immunosuppressive Therapy and Their Effects on Disease Mortality.

BACKGROUND AND AIMS: There is controversy as to whether the risk of relevant infection in IBD is related to immunosuppressants or the disease itself. The aims of this study were to evaluate: [1] the life-long prevalence and types of relevant infections in patients with IBD related to immunosuppressive treatment, and [2] the relationship of both infection and patient comorbidity to mortality. METHODS: Observational multicentre retrospective study of IBD patients that presented a relevant infection. For each case, four periods of infection exposure were analysed: P1: pre-IBD diagnosis, P2: from IBD diagnosis to immunosuppressant initiation, P3: during immunosuppressant therapy, and P4: after treatment withdrawal. RESULTS: The life-long prevalence of relevant infection in the total cohort of patients [6914] was 3%, and 5% in immunosuppressed patients [4202]. 366 relevant infections were found in 212 patients [P1: 9, P2: 17, P3: 334, and P4: 6]. Differences between periods were significant [p < 0.0001]. The most frequent types of infection were respiratory, intestinal and urinary. The most frequent opportunistic infections were tuberculosis [prevalence: 2.6/1000] and herpes zoster [prevalence: 3.9/1000]. Herpes zoster infection was associated with thiopurines alone or in combination with anti-TNF in 75% of the cases, whereas tuberculosis was associated with anti-TNF in 94% of patients. The overall mortality was 4.2%. Infection-related mortality was 2.8% and it was not influenced by comorbidity. CONCLUSIONS: Relevant infections in IBD patients are rare and appear to be related to immunosuppression. Relevant infection is a major cause of death in IBD.

Fatigue in out-patients with inflammatory bowel disease: Prevalence and predictive factors.

BACKGROUND AND AIM: Fatigue is a common and bothersome symptom in inflammatory bowel disease (IBD) patients. The study was aimed to determine the relationship of biological and psychological factors with IBD-related fatigue. METHODS: Consecutive clinically inactive IBD outpatients receiving immunosuppressants or biological drugs were enrolled between January and December 2013. Patients completed a Fatigue score (FACIT-F), various psychological, quality of life (IBDQ-9), and IBD activity scores. Biological parameters were assessed, including levels of interleukins (IL-5, IL-8 and IL-12) and micronutrients. RESULTS: We prospectively recruited 202 patients (28% ulcerative colitis and 72% Crohn's disease) for the study. Fatigue measured by FACIT-F score was prevalent in the studied population (54%, 96/177) and higher than in the general population. In the univariate analysis no relation was found between IL levels or micronutrient deficiencies and fatigue. Fatigue was significantly related to female sex, Crohn's disease, joint disorders, body mass index (BMI), psychological tests, thiopurine use, and anti-TNF treatment. All these variables were included in the multivariate analysis. Female sex (OR: 4.8), high BMI (OR:1.2) and higher depression rates (OR:1.2) were predictors of increased fatigue. High IBDQ-9 score (OR: 0.82) was significantly related to lower degrees of fatigue. CONCLUSION: Fatigue was prevalent in quiescent IBD patients with moderate-to-severe disease. It was associated with high levels of depression, low quality of life, and female sex. No association was found with the other biological and psychological factors evaluated.

Good diagnostic accuracy of a chemiluminescent immunoassay in stool samples for diagnosis of Helicobacter pylori infection in patients with dyspepsia.

Laboratory-based chemiluminescence immunoassays (CLIA) are widely used in clinical laboratories. Some years ago, a CLIA test was developed for the detection of Helicobacter pylori in stool samples, known as LIAISON H. pylori SA, but little information on its use has been reported. To evaluate the accuracy of the LIAISON H. pylori SA assay for diagnosing H. pylori infection prior to eradication treatment. Diagnostic reliability was evaluated in 252 untreated consecutive patients with dyspepsia. The gold standard for diagnosing H. pylori infection was defined as the concordance of the rapid urease test (RUT), histopathology and urea breath test (UBT). The CLIA assay was performed according to the manufacturer's instructions. Sensitivity, specificity, positive and negative predictive values, and 95% CIs were calculated. According to the gold standard selected, 121 patients were positive for H. pylori infection and 131 negative. LIAISON H. pylori SA had a sensitivity of 90.1% and a specificity of 92.4%, with positive and negative predictive values of 91.6% and 90.1%, respectively. The accuracy of the LIAISON H. pylori SA chemiluminescent diagnostic assay seems comparable to that of ELISA or the best-performing LFIAs. Its sensitivity and specificity, however, seem slightly lower than those of histology, RUT or UBT. The advantages of the assay are that it is cheap, automated, and minimally labor-intensive.

Diagnostic accuracy of three monoclonal stool tests in a large series of untreated Helicobacter pylori infected patients.

OBJECTIVES: Immunochromatographic tests need to be improved in order to enhance their reliability. Recently, several new kits have appeared on the market. The objective was to evaluate the diagnostic accuracy of three monoclonal rapid stool tests - the new Uni-Gold™ H.pylori Antigen (Trinity Biotech, Ireland), the RAPID Hp StAR (Oxoid Ltd., UK) and the ImmunoCard STAT! HpSA (Meridian Diagnostics, USA) - for detecting H. pylori infection prior to eradication treatment. DESIGN AND METHODS: Diagnostic accuracy (sensitivity and specificity) and reliability (concordance between observers) were evaluated in 250 untreated consecutive dyspeptic patients. The gold standard for diagnosing H. pylori infection was defined as the concordance of two or more of rapid urease test (RUT), histopathology and urease breath test (UBT) or positive culture in isolation. Readings of immunochromatographic tests were performed by two different observers. Sensitivity, specificity, positive and negative predictive values and 95% confidence intervals were calculated. Sensitivity and specificity were compared using the McNemar test. RESULTS: The three tests showed a good correlation, with Kappa values>0.9. RAPID Hp StAR had a sensitivity of 91%-92% and a specificity ranging from 77% to 85%. Its sensitivity was higher than that of Uni-Gold™ H.pylori Antigen and ImmunoCard STAT! HpSA (p<0.01). Uni-Gold™ H.pylori Antigen kit showed a sensitivity of 83%, similar to ImmunoCard STAT! HpSA. Specificity of Uni-Gold™ H.pylori Antigen approached 90% (87-89%) and was superior to that of RAPID Hp StAR (p<0.01). CONCLUSIONS: Uni-Gold™ H.pylori Antigen and ImmunoCard STAT! HpSA present similar levels of diagnostic accuracy. RAPID Hp StAR was the most sensitive but less reliable of the three immunochromatographic stool tests. None are as accurate and reliable as UBT, RUT and histology.

Occult H. pylori infection partially explains 'false-positive' results of (13)C-urea breath test.

BACKGROUND: In a previous study, UBiT-100 mg, (Otsuka, Spain), a commercial (13)C-urea breath test omitting citric acid pre-treatment, had a high rate of false-positive results; however, it is possible that UBiT detected low-density 'occult' infection missed by other routine reference tests. We aimed to validate previous results in a new cohort and to rule out the possibility that false-positive UBiT were due to an 'occult' infection missed by reference tests. METHODS: Dyspeptic patients (n = 272) were prospectively enrolled and UBiT was performed, according to the manufacturer's recommendations. Helicobacter pylori infection was determined by combining culture, histology and rapid urease test results. We calculated UBiT sensitivity, specificity, positive and negative predictive values (with 95% CI). In addition, we evaluated 'occult' H. pylori infection using two previously-validated polymerase chain reaction (PCR) methods for urease A (UreA) and 16 S sequences in gastric biopsies. We included 44 patients with a false-positive UBiT, and two control groups of 25 patients each, that were positive and negative for all H. pylori tests. RESULTS: UBiT showed a false-positive rate of 17%, with a specificity of 83%. All the positive controls and 12 of 44 patients (27%) with false-positive UBiT were positive for all two PCR tests; by contrast, none of our negative controls had two positive PCR tests. CONCLUSIONS: UBiT suffers from a high rate of false-positive results and sub-optimal specificity, and the protocol skipping citric acid pre-treatment should be revised; however, low-density 'occult' H. pylori infection that was undetectable by conventional tests accounted for around 25% of the 'false-positive' results.

A new validation of the Spanish Work Productivity and Activity Impairment Questionnaire-Crohn's disease version.

OBJECTIVES: The Work Productivity and Activity Impairment Questionnaire (WPAI) is an instrument that measures work impairment in the setting of different diseases. One previous study validating the WPAI in Crohn's disease (CD) patients suggested that its reproducibility may be unsatisfactory. This study evaluated the validity and reproducibility of the Spain Spanish version of the WPAI questionnaire in CD patients. METHODS: In a prospective study, convergent validity was tested comparing WPAI with quality of life and CD activity indices. Known-groups validity was assessed by comparing WPAI scores in CD patients with active versus inactive disease. Reproducibility of repeated tests was evaluated by comparing two WPAI measures obtained two to four weeks apart in stable patients. RESULTS: One hundred eight patients were included in the various steps of the analysis. The WPAI showed adequate known groups validity and convergent validity. The reproducibility of the test and, specifically, that of the evaluation of presenteeism (the impairment of productivity while working) were good. CONCLUSIONS: This study confirms the validity of WPAI for measuring work impairment in CD patients. In contrast to previous studies, the test reproducibility was adequate.

Real-time PCR improves Helicobacter pylori detection in patients with peptic ulcer bleeding.

BACKGROUND AND AIMS: Histological and rapid urease tests to detect H. pylori in biopsy specimens obtained during peptic ulcer bleeding episodes (PUB) often produce false-negative results. We aimed to examine whether immunohistochemistry and real-time PCR can improve the sensitivity of these biopsies. PATIENTS AND METHODS: We selected 52 histology-negative formalin-fixed paraffin-embedded biopsy specimens obtained during PUB episodes. Additional tests showed 10 were true negatives and 42 were false negatives. We also selected 17 histology-positive biopsy specimens obtained during PUB to use as controls. We performed immunohistochemistry staining and real-time PCR for 16S rRNA, ureA, and 23S rRNA for H. pylori genes on all specimens. RESULTS: All controls were positive for H. pylori on all PCR assays and immunohistochemical staining. Regarding the 52 initially negative biopsies, all PCR tests were significantly more sensitive than immunohistochemical staining (p<0.01). Sensitivity and specificity were 55% and 80% for 16S rRNA PCR, 43% and 90% for ureA PCR, 41% and 80% for 23S rRNA PCR, and 7% and 100% for immunohistochemical staining, respectively. Combined analysis of PCR assays for two genes were significantly more sensitive than ureA or 23S rRNA PCR tests alone (p<0.05) and marginally better than 16S rRNA PCR alone. The best combination was 16S rRNA+ureA, with a sensitivity of 64% and a specificity of 80%. CONCLUSIONS: Real-time PCR improves the detection of H. pylori infection in histology-negative formalin-fixed paraffin-embedded biopsy samples obtained during PUB episodes. The low reported prevalence of H. pylori in PUB may be due to the failure of conventional tests to detect infection.

Development and validation of the Crohn's disease perceived work disability questionnaire.

BACKGROUND: No validated instruments have been developed to measure work disability in Crohn's disease (CD). The aim of our study was to develop and validate a CD perceived work disability questionnaire (CPWDQ). METHODS: Development phase: an initial questionnaire containing 52 items was obtained from patients' interviews plus additional sources; it was completed by 106 patients and the 16 most significant items were selected using a psychometric method in order to create the CPWDQ. Validation phase: The validation assessed the questionnaire's convergent validity, discriminant validity, test-retest reproducibility, and internal consistency in 108 patients. Spearman rank correlation, t-test, intraclass correlation, and Cronbach's alpha were used for the analysis. RESULTS: Convergent validity was confirmed by good correlations between the CPWDQ and: clinical activity (r = 0.59, P < 0.01), the Short Inflammatory Bowel Disease Questionnaire, IBDQ-9, (r = 0.76, P < 0.001), Euroqol-5D (r = 0.53, P < 0.01), and overall work impairment (WPAI_CD) r = 0.66 (P < 0.01). Discriminant validity: CPWQ scores were higher in patients expected to have more severe disability, that is, in patients with active disease (n = 38) 32.3 ± 7.3 versus inactive (n = 70) 22.6 ± 5.9 (P < 0.001), in those requiring previous sick leave 30.7 ± 7.5 (n = 45) versus no sick leave 22.6 ± 6.6 (n = 63) (P < 0.01), and in those requiring hospitalization 32.2 ± 8.6 (n = 18) versus no hospitalization 24.7 ± 7.1 (n = 90) (P < 0.01). Internal consistency was also good (Cronbach's alpha = 0.89). Reproducibility: CPWDQ measures obtained 2 weeks apart showed an excellent intraclass correlation coefficient: 0.89 (95% CI: 0.83-0.93). CONCLUSIONS: The CPWDQ seems to be a valid, reliable tool for measuring subjective work disability in CD.

Accuracy of monoclonal stool tests for determining cure of Helicobacter pylori infection after treatment.

BACKGROUND: Studies comparing new monoclonal fecal tests for evaluating cure of Helicobacter pylori infection after treatment are scarce. The objective was to compare the diagnostic accuracy of three monoclonal stool tests: two rapid in-office tools -RAPID Hp StAR and ImmunoCard STAT! HpSA - and an EIA test - Amplified IDEIA Hp StAR. MATERIALS AND METHODS: Diagnostic reliability of the three tests was evaluated in 88 patients at least 8 weeks after H. pylori treatment. Readings of immunochromatographic tests were performed by two different observers. Sensitivity, specificity, positive and negative predictive values and 95% confidence intervals were calculated. RESULTS: All tests presented similar performance for post-eradication testing. Sensitivity for detecting persistent infection was 100% for both Amplified IDEIA and RAPID Hp StAR and 90% for ImmunoCard STAT! HpSA. Respective specificities were 94.9%, 92.3-93.6% and 94.9%. Negative predictive values were very high (100%, 100% and 98.7% respectively). But positive predictive values were lower, ranging from 62.5 to 71.4%. CONCLUSION: All monoclonal fecal tests in this series presented similar performance in the post-treatment setting. A negative test after treatment adequately predicted cure of the infection. However, nearly a third of tests were false positive, showing a poor predictive yield for persistent infection.

Comparative accuracy of 3 monoclonal stool tests for diagnosis of Helicobacter pylori infection among patients with dyspepsia.

BACKGROUND: Well-devised studies comparing new but different monoclonal fecal tests for diagnosing Helicobacter pylori infection are scarce. The objective of this study was to compare the diagnostic accuracy of 3 monoclonal stool tests: 2 rapid in-office tools-RAPID Hp StAR and ImmunoCard STAT! HpSA-and an enzyme immunoassay test-Amplified IDEIA Hp StAR-for diagnosing H. pylori infection prior to eradication treatment. METHODS: Diagnostic reliability was evaluated in 199 untreated consecutive patients with dyspeptic symptoms. The gold standard for diagnosing H. pylori infection was defined as the concordance of the rapid urease test, histopathology, and urea breath test. Readings of immunochromatographic tests were performed by 2 different observers. Sensitivity, specificity, positive and negative predictive values, and 95% confidence intervals were calculated. Sensitivity and specificity were compared using the McNemar test. RESULTS: The sensitivity and specificity of Amplified IDEIA Hp StAR were 90% and 89%, respectively. This enzyme immunoassay test was significantly more sensitive than ImmunoCard STAT! HpSA and more specific than RAPID Hp StAR. The sensitivity and specificity of RAPID Hp StAR were 91% and 80%, respectively, according to observer 1, and 92% and 76%, respectively, according to observer 2. It was significantly more sensitive and less specific than ImmunoCard STAT! HpSA. The sensitivity and specificity of ImmunoCard STAT! HpSA were 69% and 90%, respectively, according to observer 1, and 74% and 89%, respectively, according to observer 2. CONCLUSIONS: Amplified IDEIA Hp StAR seems to be the most accurate stool test for diagnosing H. pylori for patients with dyspeptic symptoms. The currently available in-office tests obtain slightly less reliable results.

Analysis of court criteria for awarding disability benefits to patients with Crohn's disease.

BACKGROUND & AIMS: Chronic disability and its consequences for social life and employment are important but often neglected aspects of Crohn's disease. No specific scores have been developed to evaluate chronic disability in patients with Crohn's disease; the medical criteria used by government authorities to award disability benefits have not been analyzed. We aimed to determine the courts' criteria for awarding disability benefits to patients with Crohn's disease in Spain. METHODS: We systematically searched case law databases in Spain's regional Supreme Courts to identify sentences regarding awards of disability benefits to patients with Crohn's disease. Selected decisions were reviewed to extract variables related to the awarding of benefits. Univariate and multivariate analyses were performed to determine which variables predicted the awarding of benefits. RESULTS: Two hundred eighty sentences were reviewed. The rate of judicial decisions in favor of the claimants varied considerably between the various tribunals. Multivariate analysis showed that adequate description of the disease (odds ratio, 8.6), fecal incontinence (odds ratio, 8.9), the number of associated diseases (odds ratio, 2.3), and the presence of an ostomy (odds ratio, not estimable) were independent predictors of the awarding of Social Security benefits. CONCLUSIONS: The amount of Social Security benefits awarded to patients with Crohn's disease varied depending on the tribunal. The most important predictors of a court's disability award were the adequate description of the patient's disease, fecal incontinence, associated diseases, and presence of an ostomy.

Validation of the Spanish Work Productivity and Activity impairment questionnaire: Crohn's disease version.

BACKGROUND: The Work Productivity and Activity Impairment questionnaire has only been partially validated in Crohn's disease. OBJECTIVE: To test the Work Productivity and Activity Impairment questionnaire for use in Crohn's disease patients. METHODS: A validated Spanish translation of the test was assessed. 'Discriminant validity' was evaluated by comparing Work Productivity and Activity Impairment scores in Crohn's disease patients with active versus inactive disease, and in patients versus healthy controls. 'Convergent validity' was tested comparing Work Productivity and Activity Impairment questionnaire with quality of life, Crohn's disease activity index and a debriefing questionnaire. 'Reproducibility' of repeated tests was evaluated by comparing two Work Productivity and Activity Impairment measures obtained 2 weeks apart in stable patients. 'Responsiveness' was determined by comparing Work Productivity and Activity Impairment values in the same patients during a flare-up of Crohn's disease and during remission. The Wilcoxon test for paired data and the Mann-Whitney U test for unpaired data were used for comparisons. RESULTS: One hundred and six patients were included in the various steps of the analysis. All Work Productivity and Activity Impairment parameters showed adequate discriminant and convergent validity and responsiveness. The test's reproducibility was also adequate, except for the evaluation of presenteeism (the impairment of productivity while working). CONCLUSION: The Spanish Work Productivity and Activity Impairment questionnaire is a valid and reliable measurement of work impairment in Crohn's disease. Unexpectedly, the test did not present satisfactory reproducibility for the evaluation of presenteeism. The reliability of this last finding should be evaluated in further studies.

Accuracy of diagnostic tests for Helicobacter pylori: a reappraisal.

BACKGROUND: Despite many changes, no large studies comparing the different diagnostic tests for Helicobacter pylori have been performed in the past 10 years. In this time, monoclonal stool antigen immunoassays and in-office 13C-urea breath tests (UBTs) have appeared. The aim of this study was to evaluate the accuracy of invasive and noninvasive tests in a large series of dyspeptic patients. METHODS: A total of 199 dyspeptic patients who had not previously been treated for H. pylori infection were prospectively enrolled. Noninvasive analyses included a commercial infrared-based UBT and a commercially available stool test. Biopsy-based tests included histological examination and a rapid urease test. A patient was considered to be infected when at least 2 test results were positive. Sensitivity, specificity, positive and negative predictive values, and 95% confidence intervals were calculated. The test results were compared using the McNemar test. RESULTS: Rates of positive test results were similar (54%) for the rapid urease test, histopathological examination, and the stool test. By contrast, 75% of UBT results were positive, and the UBT was associated with a very low specificity (60%). For this reason, the delta cutoff value for the UBT was recalculated as 8.5%. Sensitivities and specificities with this new cutoff value were 95% and 100%, respectively, for the rapid urease test; 94% and 99%, respectively, for histopathological examination; 90% and 93%, respectively, for the stool test; and 90% and 90%, respectively, for the UBT. CONCLUSIONS: Histological examination and rapid urease testing showed excellent diagnostic reliability. The stool test seems to be a good, noninvasive alternative to endoscopy-based tests. By contrast, the infrared-based UBT evaluated in our study showed a lower than expected performance, which was partially corrected when the cutoff value for the test was recalculated.

Evaluation of four different fecal tests for determination of cure after Helicobacter pylori treatment.

BACKGROUND: Data evaluating the monoclonal tests for determination of cure after Helicobacter pylori treatment are scarce. GOALS: This study was aimed to evaluate the usefulness of 4 stool tests-2 new RAPID monoclonal immunochromatographic tests (RAPID Hp StAR, DakoCytomation, Cambridge, UK and ImmunoCard STAT! HpSA, Meridian Diagnostics, Cincinnati, OH) a monoclonal EIA test (Amplified IDEIA Hp StAR, DakoCytomation, Cambridge, UK), and a polyclonal EIA test (Premier Platinum HpSA, Meridian Diagnostics, Cincinnati, OH)-to confirm cure of H. pylori infection after eradication treatment. STUDY: Ninety-seven patients who underwent eradication treatment were included. Cure of H. pylori infection was determined using 2 consecutive reference tests. Fecal tests were performed according to the specifications of the manufacturer. Sensitivity, specificity, and positive and negative predictive values were calculated. RESULTS: After H. pylori eradication, the RAPID Hp StAR test has a sensitivity of 73% for detecting persistent infection, a specificity of 96% to 98%, a positive predictive value of 73% to 80% and a negative predictive value of 96%. For ImmunoCard STAT! HpSA the corresponding values were 91%, 97%, 77%, and 99%, for Amplified IDEIA Hp StAR 73%, 97%, 73%, and 97%, and for Premier Platinum HpSA 91%, 79%, 35%, and 98%. CONCLUSIONS: All tests except Premier Platinum HpSA were highly accurate confirming eradication after treatment.

Remission on thiopurinic immunomodulators normalizes quality of life and psychological status in patients with Crohn's disease.

BACKGROUND: Thiopurinic immunomodulators are effective for maintaining symptom remission in Crohn's disease. Little is known, however, about their effect on patients' quality of life or psychological well-being. The present study aimed to determine whether remission induced by thiopurinic immunomodulators returns levels of quality of life and psychological well-being to normal. MATERIALS AND METHODS: A case-control study was performed. Cases were 33 patients with Crohn's disease treated with azathioprine or 6-mercaptopurine and in stable remission for at least 6 months. Sixty-six healthy individuals matched 2:1 by age and sex and 14 patients with active Crohn's disease were included as control groups. Quality of life was evaluated with the Short Form (SF-36) questionnaire, and the respective Hamilton rating scales were used for anxiety and depression. ANOVA with Bonferroni's correction was used for multiple comparisons. RESULTS: SF-36 global scores were 85 in the study group, 85 in healthy controls (P = 1), and 58.6 in patients with active disease (P < 0.001 for the comparison with the other 2 groups). The differences between values were 0 (95% CI -4-4), 26.4 (95% CI 20-32), and 26.4 (95% CI 19-33), respectively. The respective anxiety and depression scores were 6.5, 5.5, and 16.2 and 3.7, 3.3, and 10.9. No significant differences were observed in any of the SF-36 domains between case and control groups, whereas in patients with active disease, all domains were significantly worse. CONCLUSIONS: Thiopurinic immunomodulator-induced remission restores normal levels of quality of life and psychological well-being in Crohn's disease patients.

Ranitidine-bismuth citrate, tetracycline and metronidazole followed by triple therapy as alternative strategy for Helicobacter pylori treatment: a pilot study.

BACKGROUND: Eradication rates of triple therapy--a proton pump inhibitor, clarithromycin and amoxicillin twice daily for 7 days--are suboptimal in some areas of the world. Triple therapy combining ranitidine-bismuth citrate, tetracycline and metronidazole is a very effective second-line therapy. Management strategies including this treatment as first-line therapy may represent a reasonable choice. AIM: To evaluate the efficacy of a strategy combining ranitidine-bismuth citrate triple therapy followed by a proton pump inhibitor-based triple therapy for Helicobacter pylori eradication in a pilot study. PATIENTS AND METHODS: One hundred and thirty-six consecutive H. pylori-positive patients were treated with 400 mg ranitidine-bismuth citrate twice daily, 500 mg tetracycline three times daily and 500 mg metronidazole three times daily for 7 days. Second-line therapy consisted of 20 mg omeprazole twice daily, 500 mg clarithromycin twice daily and 1 g amoxicillin twice daily for 7 days. The efficacy of the treatment was evaluated by histology or the urea breath test. RESULTS: Cure rates were 109/136 patients [80.2%; 95% confidence interval (CI), 72-86%] by intention to treat and 109/127 (85.8%; 95% CI, 78-91%) per protocol. Fifteen of the patients with treatment failure received second-line treatment. Cure rates for the strategy as a whole were 119/136 (87.5%; 95% CI, 81-92%) by intention to treat and 119/123 (96.8%; 95% CI, 92-99%) per protocol. CONCLUSIONS: The strategy achieves good eradication rates. As the first-line therapy avoids the use of clarithromycin, it could be useful in areas where high resistance to this antibiotic lead to poor results with triple therapy.

[Testing a new in-office test for determination of faecal Helicobacter pylori antigen]. / Evaluación de un nuevo test rápido para la detección de Helicobacter pylori en heces.

BACKGROUND: To date, the search for an in-office reliable test for Helicobacter pylori infection has been unsuccessful. The aim of the present study was to evaluate a new immunocromatographic in-office test using monoclonal antibodies to determine the presence of Helicobacter pylori antigen in faeces (Stick H. pyl, Operon S.A. Zaragoza). We compared its reliability and reproducibility to the currently available test (HpSA, EIA, Premier Platinum HpSA, Meridian Diagnosis Inc, Cincinnati, Ohio). PATIENTS AND METHOD: 71 consecutive dyspeptic patients were enrolled. Helicobacter pylori status was determined by rapid urease test and Giemsa stain of antral biopsy. Patients with a positive result in the two tests were considered as infected and those with a negative result in both tests were regarded as not infected. Faecal Helicobacter pylori antigen was tested twice by means of HpSA. Four consecutive determinations of Stick H. pyl were also performed. We calculated sensitivity, specificity and positive and negative predictive values of each determination. Concordance between determinations was estimated by the kappa statistics. RESULTS: Forty-eight of 68 patients were infected by Helicobacter pylori. Sensitivity, specificity and positive and negative predictive values were 89-96%, 60-70% 85-88% and 74-87%, respectively, for Stick H. pyl and 70-75%, 60-85%, 85-92% and 55-80%, respectively, for HpSA. Correlation coefficients were 0.82-0.93 for Stick H. pyl and 0.57 for HpSA. CONCLUSIONS: The new Stick H. pyl test shows excellent sensitivity and reproducibility for diagnosis of H. pylori infection. Its reliability appears to be far better than that of HpSA.

Evaluación de un nuevo test rápido para la detección de Helicobacter Pylori en heces / Testing a new in-office test for determination of faecal Helicobacter pylori antigen

FUNDAMENTO: El objetivo del presente estudio fue evaluar la fiabilidad diagnóstica y reproducibilidad de una nueva prueba rápida inmunocromatográfica (Stick H. pyl, Operon SA, Zaragoza), que utiliza anticuerpos monoclonales para la detección de antígeno de Helicobacter pylori en heces, y compararla con la prueba actualmente comercializada (HpSA, EIA, Premier Platinum HpSA, Meridian Diagnosis Inc, Cincinnati, Ohio). MÉTODO: Se incluyó a 71 pacientes sometidos a endoscopia para estudio de síntomas dispépticos. Se practicaron biopsias para CLO-test e histología antral. Se consideró infectados por Helicobacter pylori a aquellos pacientes que presentaban histología y CLO-test positivos, y no infectados a aquellos con ambos tests negativos. En heces se realizaron 2 determinaciones seriadas de antígeno de Helicobacter pylori mediante HpSA y 4 determinaciones consecutivas con Stick H. pyl. Se calcularon la sensibilidad, la especificidad y los valores predictivos positivo y negativo. La concordancia entre determinaciones se evaluó mediante el estadístico kappa. RESULTADOS: De los 68 pacientes evaluables, 48 presentaban infección por Helicobacter pylori. La sensibilidad, la especificidad y los valores predictivos positivo y negativo en las distintas determinaciones oscilaron entre 89-96 por ciento, 60-70 por ciento, 85-88 por ciento y 74-87 por ciento respectivamente para Stick H. pyl frente al 70-75 por ciento, 60-85 por ciento, 85-92 por ciento y 55-80 por ciento para HpSA. Los índices de concordancia variaron entre 0,82 y 0,93 para Stick H. pyl frente a 0,57 para HpSA. CONCLUSIONES: Stick H. pyl en heces presenta excelentes sensibilidad y reproducibilidad para el diagnóstico de la infección por Helicobacter pylori. Su fiabilidad es superior a la de HpSA (AU)