Negative Urea Breath Test Research Articles

Helicobacter pylori incidence and re-infection in the Aklavik H. pylori Project

BackgroundThe Aklavik H. pylori Project (AHPP) (www.canhelpworkinggroup.ca) is a community-driven project examining Helicobacter pylori infection and its influence on health in a diverse Aboriginal community in the Northwest Territories. Initial research revealed that 58% of 333 participants who underwent a urea breath test (UBT) between 2007 and 2010 were H. pylori-positive. From 2008 to 2010, we offered treatment to H. pylori-positive participants and 113 consented to this treatment.ObjectiveWe estimated H. pylori incidence in AHPP participants who initially tested negative and the re-infection frequency in initially positive participants who were successfully treated to clear the infection.MethodsParticipants who were initially H. pylori-negative or negative after treatment during 2008–2010 were eligible for inclusion. From November 2011 to June 2012, participants were offered a UBT and the samples were analyzed using infrared spectroscopy (IRIS). Participants with a positive test result were classified as new cases for estimating incidence among participants testing negative at baseline and re-infection among those successfully treated for H. pylori infection.ResultsAmong 38 initially negative participants, follow-up UBT showed that 33 remained negative, 3 were positive, and 2 had uncertain status. The estimated incidence proportion during the follow-up period was 8.3% (95% CI: 1.8–22.0%). Among 43 participants with a negative post-treatment UBT, 41 remained negative and 2 were positive. The estimated re-infection proportion during the follow-up period was 4.7% (95% CI: 0.6–16.0%). The frequency of new cases was similar in males and females. Aboriginal participants had a combined re-infection/incidence rate of 2.4% per year (95% CI: 0.8–5.9% per year). All 9 non-Aboriginal participants remained free from infection throughout the study period, as did all 23 participants aged 55 years and above.ConclusionsThe AHPP has substantially reduced the burden of infection in Aklavik since 2008. Continued monitoring, treatment, community engagement and knowledge translation activities are needed to ensure a lasting benefit of the project.

Penbactam for Helicobacter pylori eradication: A randomised comparison of quadruple and triple treatment schedules in an Iranian population

Background & study aimsSelection of the best drug regimens for eradication of Helicobacter pylori infection especially in patients at risk of peptic ulcer relapses and the development of complications is challenging. This study assessed and compared the efficacy of the two common PPI based triple therapies to a quadruple therapy including PPI, metronidazole, amoxicillin and a bismuth compound in Iranian population. Patients & MethodsThree hundred and thirty patients with peptic ulcer and H. pylori infection were included in the study. Patients were randomly assigned to one of the three treatment protocols all given twice daily: (a) A 14-day quadruple therapy (OMAB group) comprising omeprazole 20mg, metronicazole 500mg, amoxicillin 1g, and bismuth subcitrate 240mg; (b) A 14-day triple regimen (OCP group) comprising omeprazole 20mg plus clarithromycine 500mg and penbactam 750mg and (c) A 14-day triple regimen (OCA group) comprising omeprazole 20mg plus clarithromycine 500mg and amoxicillin 1g. Cure was defined as a negative urea breath test at least six weeks after treatment. ResultsThe per-protocol eradication rates achieved with both OCP regimen (87.0%) and OCA treatment (90.8%) were significantly higher than the OMAB treatment protocol (56.0%); however, no significant difference emerged in eradication rates between the two triple treatment schedules. No significant differences between the groups were found in most side-effects. ConclusionTwo-week quadruple therapy showed a lower eradication rate compared to common triple treatment schedules when used as first-line eradication treatment for H. pylori infection in Iranian population.

A Randomized Controlled Trial Comparing Sequential with Triple Therapy forHelicobacter pyloriin an Aboriginal Community in the Canadian North

Helicobacter pylori infection occurs more frequently in Arctic Aboriginal settings than elsewhere in North America and Europe. Research aimed at reducing health risks from H pylori infection has been conducted in the Aboriginal community of Aklavik, Northwest Territories. To compare the effectiveness of the Canadian standard therapy with an alternative therapy for eliminating H pylori infection in Aklavik. Treatment-naive H pylori-positive individuals were randomly assigned to a 10-day regimen (oral twice-daily doses) with rabeprazole (20 mg): standard triple therapy (proton pump inhibitor, added clarithromycin [500 mg] and amoxicillin [1 g] [PPI-CA]); sequential therapy (ST) added amoxicillin (1 g) on days 1 to 5, and metronidazole (500 mg) and clarithromycin (500 mg) on days 6 to 10. Participants with clarithromycin-resistant H pylori were randomly assigned to ST or quadruple therapy. Treatment effectiveness was estimated as per cent (95% CI) with a negative urea breath test at least 10 weeks after treatment. Of 104 (53 PPI-CA, 51 ST) randomized participants, 89 (49 PPI-CA, 40 ST) had post-treatment results. Per-protocol treatment effectiveness was 59% (95% CI 45% to 73%) for PPI-CA and 73% (95% CI 58% to 87%) for ST. Based on intention to treat, effectiveness was 55% (95% CI 41% to 69%) for PPI-CA and 57% (95% CI 43% to 71%) for ST. Of 77 participants (43 PPI-CA, 34 ST) with 100% adherence, effectiveness was 63% (95% CI 43% to 82%) for PPI-CA and 81% (95% CI 63% to 99%) for ST. While additional evidence is needed to confirm that ST is more effective for Arctic Aboriginal communities than the Canadian standard H pylori treatment, these results show standard PPI-CA treatment to be inadequate for communities such as Aklavik.

Helicobacter Pylori Breath Testing in an Open Access System has a High Rate of Potentially False Negative Results due to Protocol Violations

Among available tests to detect Helicobacter pylori (H.pylori), urea breath test (UBT) is the most accurate when performed correctly in research protocols with unknown validity in clinic settings. A total of 595 subjects at a gastroenterology clinic were tested 620 times with UBT. Detailed information about three known factors (recent proton-pump inhibitors (PPI), antibiotics, or bismuth, H.pylori eradication treatment finished <4weeks ago, and gastric resection) to make UBT unreliable were prospectively recorded before each test. Twenty-three percent (120 of 526) of all negative tests fell in one or more of the three categories, which had the potential to make UBT unreliable. Of those carried out on persons without being treated before, the potential false negative rate was 15%. Among those with previous eradication treatment, the rate was around 45%. If a negative UBT could be false negative in up to 23% of cases, then it has a serious lack of negative predictive value. A negative UBT should be considered false negative until potential protocol violations are excluded.

Abstract SY26-02: SWOG S0701 phase III randomized trial of three antibiotic regimens to eradicate helicobacter pylori: efficacy and failure at one year

Abstract Background: Gastric cancer is the fourth most common cancer and the second cause of cancer death worldwide. In several Latin American countries, it is the most common cancer and the most common cause of cancer death in men and women combined. Infection with H. pylori (Hp) is associated with the development of gastric carcinoma in many parts of the world including Latin America and is thought to be one of the causative agents. We conducted a clinical trial designed to test the effectiveness of three antibiotic regimens for Hp eradication in seven sites in Latin America while assessing feasibility, and the possibility of identifying a direction for future chemoprevention trials of gastric cancer. Methods: Under a locally IRB approved clinical protocol and signed informed consent requirement, 1852 adults (ages 21-65 years) from the general populations of Chile (Santiago), Colombia (Túquerres), Costa Rica (Guanacaste), Honduras (Copán), México (Obregon and Tapachula), and Nicaragua (León) were screened for the presence of Hp infection with the urea breath test (UBT). 79.4% were positive. 1463 participants consented to be randomized to one of three regimens administered twice a day: 14 days of lansoprazole 30mg, amoxicillin 1,000mg, and clarithromycin 500mg (triple 14d); 5 days of lansoprazole 30mg and amoxicillin 1,000mg followed by 5 days of lansoprazole 30mg, clarithromycin 500mg, and metronidazole 500mg (sequential 10d) or 5 days of lansoprazole 30mg, amoxicillin 1,000mg, and clarithromycin 500mg, and metronidazole 500mg (concomitant 5d). Response was assessed at 6-8 weeks after treatment by UBT. Recurrence at one year was also assessed by UBT. Results are presented by UBT testing and by all participants enrolled (intention-to-treat (ITT)) analysis. 123 (30.8%) patients who did not return for UBT testing were presumed failures at one year. Studies of HP virulence, pepsinogens I and II, as well as inflammatory cytokines, are in progress. Results: Participant characteristics were similar in the three treatment groups. At 6-8 weeks after treatment, UBT was negative in 1133/1414 (80.1%) patients who underwent follow-up UBT and in 1133/1463 (77.4%) of all participants enrolled. The triple 14d regimen was the superior (p 0.008) regimen among all who had repeat UBT and in the ITT group (p 0.005). The estimated fraction remaining free of infection at one year was 79.3% among participants followed by UBT, and 72.7% for all participants enrolled in the study (Table 1). At one year, in those patients with a negative UBT at 6-8 weeks, Hp recurrence was observed in 11.5%. The risk of infection was greater by site - worse in Chile and Colombia- (p &amp;lt;0.0001), age - worse in the younger - (p 0.03), education - worse in the poorly educated - (p 0.02) and household overcrowding - worse in more crowded households - (p 0.007). Gender, prior antibiotic use, water source and sanitation were not significant factors. By multivariate analysis, the most important predictors of Hp recurrence at one year were study site (p &amp;lt;0.0001), younger age (p &amp;lt;0.001) and crowded households (p 0.003). Conclusions: This is the largest, prospective, randomized clinical trial ever conducted to treat Hp. The trial was successful in recruiting participants, as well as conducting and monitoring trial treatments and outcomes in 6 Latin American countries. We demonstrated greater treatment efficacy of the triple 14d antibiotic regimen at 6-8 weeks, but a one year 11.5% recrudescence rate regardless of antibiotic regimen. Study site, younger age and crowded households are important factors associated with Hp recurrence at one year. The recurrence rate at one year is concerning, and points to the necessity of conducting additional studies of the molecular biology and pathogenesis of Hp before launching definitive chemoprevention trials of gastric cancer. Given the unique prevalence of gastric cancer and other infection-related cancers in Latin America, we propose that Latin America investigators consider the formation of an independent Cancer Cooperative Group to facilitate research involving cancer. Just as the United States wisely invested in the development of cancer cooperative groups in Europe (European Organization for Research and Treatment of Cancer - EORTC) and in Canada (National Cancer Institute of Canada Clinical Trials Group - NCIC-CTG), we believe that the time has come for consideration of the creation of a cancer cooperative group in Latin America with financial support from the National Cancer Institute. Support: The Bill &amp; Melinda Gates Foundation grant #43930 and National Cancer Institute grant # CA037429. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 103rd Annual Meeting of the American Association for Cancer Research; 2012 Mar 31-Apr 4; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2012;72(8 Suppl):Abstract nr SY26-02. doi:1538-7445.AM2012-SY26-02

Effect of ecabet sodium treatment on urea breath test and stool antigen tests in volunteers with Helicobacter pylori infection

Ecabet sodium is reported to have a bactericidal effect on Helicobacter pylori and inhibit urease activity in vitro. Seven male volunteers (mean age, 51.3 years; range, 45-55 years) with H. pylori infection were medicated with 1 g ecabet sodium t.i.d. for 4 weeks. The urea breath test (UBT) was performed 10 times per person: before medication, seven times in 2 weeks, and once in the third and fourth weeks. Stool antigen tests (HpSA PLUS and Testmate pylori antigen) were performed five times per person: before medication and weekly during medication. The premedication UBT value ranged from 4.9 ‰ to 77.4 ‰ and from 2.9 ‰ to 44 ‰ at the end of the treatment period. Not one of the subjects had a negative UBT result during medication. The optical densities of the HpSA and Testmate pylori antigen tests ranged from 0.4 to > 3.0 premedication and from 0.0 to > 3.0 at the end of treatment. HpSA and Testmate pylori antigen were negative in two cases. In this study, ecabet sodium did not effect the results of UBT in volunteers with H. pylori infection. Ecabet sodium may influence stool antigens because in two of seven cases the H. pylori stool antigen tests returned negative results.

Helicobacter pylorieradication: Sequential therapy andLactobacillus reuterisupplementation

To evaluate the role of sequential therapy and Lactobacillus reuteri (L. reuteri) supplementation, in the eradication treatment of Helicobacter pylori (H. pylori). H. pylori infection was diagnosed in 90 adult dyspeptic patients. Patients were excluded if previously treated for H. pylori infection or if they were taking a proton pump inhibitor (PPI), H2-receptor antagonist or antibiotics. Patients were assigned to receive one of the following therapies: (1) 7-d triple therapy (PPI plus clarithromycin and amoxicillin or metronidazole) plus L. reuteri supplementation during antibiotic treatment; (2) 7-d triple therapy plus L. reuteri supplementation after antibiotic treatment; (3) sequential regimen (5-d PPI plus amoxicillin therapy followed by a 5-d PPI, clarithromycin and tinidazole) plus L. reuteri supplementation during antibiotic treatment; and (4) sequential regimen plus L. reuteri supplementation after antibiotic treatment. Successful eradication therapy was defined as a negative urea breath test at least 4 wk following treatment. Ninety adult dyspeptic patients were enrolled, and 83 (30 male, 53 female; mean age 57 ± 13 years) completed the study. Nineteen patients were administered a 7-d triple treatment: 11 with L. reuteri supplementation during and 8 after therapy. Sixty-four patients were administered a sequential regimen: 32 with L. reuteri supplementation during and 32 after therapy. The eradication rate was significantly higher in the sequential group compared with the 7-d triple regimen (88% vs 63%, P = 0.01). No difference was found between two types of PPI. No difference in eradication rates was observed between patients submitted to L. reuteri supplementation during or after antibiotic treatment. Compliance with therapy was excellent in all patients. No difference in adverse effects was observed between the different antibiotic treatments and between patients submitted to L. reuteri supplementation during and after antibiotic treatment. There was a low incidence of adverse effects in all groups of patients with sequential therapy, probably due to the presence of the L. reuteri supplementation. The sequential treatment regimen achieved a significantly higher eradication rate of H. pylori compared with standard 7-d regimen. L. reuteri supplementation could reduce the frequency and the intensity of antibiotic-associated side-effects.

Quadruple versus common triple-treatment regimens for Helicobacter pylori eradication in the Iranian population: A randomised study

Background and study aims Selection of the best drug regimens for effective eradication of Helicobacter pylori ( H. pylori) infection, especially in patients at risk of peptic ulcer relapses and development of complications of peptic ulcer disease, is challenging. This study assessed and compared the efficacy of the two common proton pump inhibitor (PPI)-based triple therapies to a quadruple therapy including PPI, metronidazole, amoxicillin and a bismuth compound in Iranian population. Patients and methods A total of 330 patients with peptic ulcer and H. pylori infection were included in the study. Patients were randomly assigned to one of the three treatment protocols: (1) a 14-day quadruple therapy (OMAB group) comprising omeprazole 20 mg, metronidazole 500 mg, amoxicillin 1 g and bismuth subcitrate 240 mg; (2) a 14-day triple regimen (OCP group) comprising omeprazole 20 mg plus clarithromycin 500 mg and penbactam 750 mg; and (3) a 14-day triple regimen (OCA group) comprising omeprazole 20 mg plus clarithromycin 500 mg and amoxicillin 1 g, all given twice daily. Cure was defined as a negative urea breath test at least 6 weeks after treatment. Results The intention-to-treat H. pylori eradication rates achieved with both OCP regimen (87.0%) and OCA treatment (88.8%) were significantly higher than the OMAB treatment protocol (56.0%); however, no significant difference emerged in eradication rates between the two triple-treatment schedules. No significant differences were found in most side effects between the groups. Conclusion Two-week quadruple therapy showed a lower eradication rate compared with common triple-treatment schedules when used as a first-line eradication treatment for H. pylori infection in the Iranian population.

Quadruple Therapy Using a 3-in-1 Capsule of Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline with Omeprazole Compared to Triple Therapy for the Eradication of Helicobacter pylori: 2010 Presidential Poster

Purpose: Although proton pump inhibitor triple therapy is recommended as first line treatment of H. pylori, eradication rates <80% have been recently reported. Bismuth containing quadruple therapy is an alternative. The efficacy of these 2 approaches was evaluated by re-analyzing 2 randomized controlled trials (RCTs). Methods: One N. American RCT comparing omeprazole plus a 3-in-1 capsule of bismuth subcitrate potassium, metronidazole, and tetracycline (OBTM) vs. omeprazole, amoxicillin and clarithromycin (OAC) each given for 10 days was combined with a European RCT comparing OBTM (10 days) vs. OAC (7 days). Both RCTs evaluated therapy in patients with upper GI symptoms, positive 13C urea breath test (UBT), a rapid urease test with at least 1 positive test from histology and culture. H. pylori eradication was confirmed by 2 negative UBTs 6 and 10 weeks post therapy. The impact of sex, age, race, presence of peptic ulcer disease (PUD), duration of OAC therapy, and pretreatment H. pylori clarithromycin and metronidazole resistance was evaluated on efficacy in univariate and multivariate analyses. All data were analyzed on an intention to treat basis. Results: 299 patients were enrolled in the N. American RCT with eradication rates in OBMT arm of 126/147 (86%; 95% CI=79%-91%) and 122/152 (80%; 95% CI=73%-86%) in OAC arm. 440 patients were enrolled in the European RCT with eradication rates of 174/218 (80%; 95% CI=74%-85%) with 10d OBTM and 123/222 (55%; 95% CI=49%-62%) with 7d OAC. There were no predictors of treatment failure in OBTM arms in univariate or multivariate analysis including H. pylori metronidazole resistant strains (81% versus 86%, p=0.23). OAC was less successful in patients without PUD vs. those with PUD (eradication rate 60% vs. 77% respectively; p=0.003), in those taking 7d vs. 10d of therapy (80% vs. 55%; p<0.0001) and in clarithromycin resistant strains (12% vs. 78%, p<0.0001). These factors remained significant in a logistic regression model adjusting for all factors outlined above. In a logistic regression model combining OBTM and OAC groups adjusting for all factors plus an interaction term for clarithromycin resistance and treatment regimen, clarithromycin resistance (p=0.004) was an independent predictor of treatment failure whereas therapy with OBTM was an independent predictor of treatment success (p=0.003). Conclusion: OBTM appears less susceptible to influence of H. pylori resistance to antibiotics and other factors in determining efficacy and overall may be a better first line choice in the treatment of H. pylori infection. Disclosure: Dr Moayyedi, Advisory Board Member, Axcan Pharma; Dr Bazzolo, Advisory Board Member, Axcan Pharma; Prof Megraud, Advisory Board Member and Dr Giguere, Employee, Axcan Pharma. This research was supported by an industry grant from Axcan Pharma.

Effect of omeprazole, rabeprazole, and rebamipide on the accuracy of urea breath test in patients with Helicobacter pylori infection

Abstract Background: The urea breath test (UBT) has been widely used for H. pylori eradication after treatment. The breath test could be adversely affected by various factors including proton pump inhibitors (PPIs) that are also used in the therapy for H. pylori infection. Objective: Determine the effect of omeprazole, rabeprazole and the mucoprotective agent rebamipide, on the UBT. Methods: Fifty-six patients with dyspepsia and positive for H. pylori by rapid urease test were enrolled. They were classified into three groups: Group 1 (n=25) received omeprazole 20 mg once daily, group 2 (n=13) received rabeprazole 20 mg once daily, and group 3 (n=18) received rebamipide 100 mg three times a day. All patients received a 14-day course of their medications. UBT was performed on day 0 as a baseline and on day 14 in all patients. In patient with negative results of UBT on day 14, the UBT was performed in consecutive week until the test became positive. Results: Fifty-six patients (20 men and 36 women) participated in the study. Their mean age was 46.77±14.3 years. False negative rate after 14-day treatment in omeprazole, rabeprazole and rebamipide group were 20.0%, 30.8%, and 0% respectively. There was a significant difference between 13C level in patients with negative and positive UBT results (2.7±0.7 vs.22.9±3.7/mL, p=0.025). The reversal of false negative to true positive tests occurred within two weeks after discontinuation of omeprazole and rabeprazole. Conclusion: Proton pump inhibitors had an effect on the accuracy of H. pylori detection using UBT. Rabeprazole revealed a higher false negative rate in the UBT than omeprazole. The mucoprotective drug, rebamipide, did not influence negative results in the UBT.

Ten-Day Sequential Therapy of Helicobacter pylori Infection in Thailand

Antimicrobial resistance has decreased eradication rates of Helicobacter pylori worldwide. The objective of this study was to determine whether a sequential therapy regimen is effective in eradicating H. pylori in adults with nonulcer dyspepsia or peptic ulcer disease in Thailand. A total of 115 patients with dyspepsia or peptic ulcer were enrolled in the study. (14)C-urea breath test, upper endoscopy, rapid urease test, bacterial culture, and antibiotic resistance assessment were conducted during the course of the treatment. In all, 115 patients underwent a 10-day sequential regimen, which consisted of lansoprazole (30 mg) plus amoxicillin (1 g) twice a day for 5 days, then lansoprazole (30 mg) with metronidazole (500 mg) twice a day, and clarithromycin (1,000 mg) once a day for another 5 consecutive days. Successful eradication was evaluated by negative urea breath test at least 4 weeks after stopping treatment. Successful eradication was achieved in 106 of 115 patients (95%). All patients completed the treatment, without any dropouts. Mild adverse effects included headache and palpitations. The prevalence rate of clarithromycin-resistant H. pylori was found to be 6.1%. The 10-day sequential treatment for H. pylori is well tolerated and provides a high eradication rate. This regimen can overcome the emergence of antibiotic resistance and may have a role as a first-line treatment for H. pylori infection in Thailand.

The effect of mastic gum on Helicobacter pylori: A randomized pilot study

Our aim was to study the effect of pure mastic gum on Helicobacter pylori (H. pylori) eradication in patients suffering from an H. pylori infection Fifty two patients were randomized to receive either 350mg three times a day (tid) of pure mastic gum for 14 days (Group A), or 1,05g tid of pure mastic gum (Group B) for 14 days, or pantoprazole 20mg twice a day (bd) plus pure mastic gum 350mg tid for 14 days (Group C) or pantoprazole 20mg bd plus amoxicillin 1g bd plus clarithromycin 500mg bd for 10 days (Group D). All patients harboured H. pylori before entering the study and that was confirmed by a (13)C urea breath test (UBT). H. pylori eradication was tested by a UBT 5 weeks after completion of the eradication regime. Eradication of H. pylori was confirmed in 4/13 patients in Group A and in 5/13 in Grour B. No patient in Group C achieved eradication whereas 10/13 patients in Group D had a negative UBT. There were no statistically significant differences in mean UBT values in Groups A, B, C although there was a trend in Group A (p=0.08) and in Group B (p=0.064). The difference was significant in Group D (p=0.01). All patients tolerated mastic gum well and no serious adverse events were reported. Mastic gum has bactericidal activity on H. pylori in vivo.

Performance of acidified 14C‐urea capsule breath test during pantoprazole and ranitidine treatment

Urea breath test (UBT) results could be false negative in patients taking antisecretory drugs. This effect would be prevented by citric acid administration during UBT. We prospectively investigated whether acidified 14C-urea capsule prevents false negative UBT results in patients taking antisecretory drugs and show interference with the duration of medications. Sixty Helicobacter pylori positive patients were included. Pantoprazole (40 mg/day) was given to 27 patients for 28 days and ranitidine (300 mg. o.d.) to 33 patients for 60 days. Urea breath tests were repeated on days 14 and 28 in both groups and on day 60 in the ranitidine group. The baseline mean breath counts of two groups did not show any significant difference. Pantoprazole led to a significant decrease in mean breath counts on day 14 (P < 0.005). Six of 27 and 3 of 25 patients taking pantoprazole developed negative or equivocal UBT results on days 14 and 28, respectively. Two of 32, 2 of 32 and 3 of 21 patients taking ranitidine developed negative or equivocal UBT results on days 14, 28 and 60, respectively. The use of acidified 14C-urea capsule did not prevent false negative UBT results in patients taking pantoprazole and ranitidine, and the duration of medication does not affect the test results.

The efficacy of Helicobacter pylori eradication regimen with and without vitamin C supplementation

Vitamin C in gastric juice and in vitro has been shown to inhibit the growth of Helicobacter pylori (H. pylori). The purpose of this study was to investigate the effect of addition of vitamin C to eradication regimen on H. pylori eradication rate. This randomised controlled clinical trial was conducted on 312 patients with H. pylori infection who had referred to the Taleghani Research Center of Gastroenterology and Liver Disease. Patients were randomly divided into two groups. Group A patients (162 patients) received amoxicillin 1g and metronidazole 500 mg b.i.d., bismuth 240 mg b.i.d. and omeprazole 40 mg q.i.d. in two divided doses. Patients in group B (150 patients) received the same regimen plus 500 mg vitamin C per day. All patients received therapy for 2 weeks. Four weeks later all patients underwent urea breath test and results were compared. A total of 140 patients in group A and 141 in group B completed the study. On intention-to-treat analysis 48.8% of patients in group A in comparison to 78% in group B responded to eradication therapy and had negative urea breath test (p<0.0001). Addition of vitamin C to H. pylori treatment regimen of amoxicillin, metronidazole and bismuth can significantly increases H. pylori eradication rate.

Helicobacter pylori related dyspepsia: prevalence and treatment outcomes at University Kebangsaan Malaysia-Primary Care Centre

BackgroundOptimum management of dyspepsia in primary care is a debatable subject. Testing for Helicobacter pylori (HP) has been recommended in primary care as this strategy will cure most underlying peptic ulcer disease and prevent future gastro duodenal disease.MethodsA total of 98 patients completed Modified Glasgow Dyspepsia Severity Score Questionnaire (MGDSSQ) at initial presentation before undergoing the 13Carbon Urea Breath Test (UBT) for HP. Those with positive UBT received Eradication Therapy with oral Omeprazole 20 mg twice daily, Clarithromycin 500 mg daily and Amoxycillin 500 mg twice daily for one week followed by Omeprazole to be completed for another 4 to 6 weeks. Those with negative UBT received empirical treatment with oral Omeprazole 20 mg twice daily for 4 to 6 weeks. Patients were assessed again using the MGDSSQ at the completion of treatment and one month after stopping treatment.ResultsThe prevalence of dyspepsia at Universiti Kebangsaan Malaysia-Primary Care Centre was 1.12% (124/11037), out of which 23.5% (23/98) was due to HP. Post treatment assessment in both HP (95.7%, 22/23) and non HP-related dyspepsia (86.7%, 65/75) groups showed complete or almost complete resolution of dyspepsia. Only about 4.3% (1/23) in the HP related dyspepsia and 13.3% (10/75) in the non HP group required endoscopy.ConclusionThe prevalence of dyspepsia due to HP in this primary care centre was 23.5%. Detection of HP related dyspepsia yielded good treatment outcomes (95.7%).

Lansoprazole was not effective in young dyspeptic patients without Helicobacter pylori

Source Citation Leung WK, Wu JC, Chan FK, et al. Initial treatment with lansoprazole in young dyspeptic patients with negative urea breath test result: a randomized controlled trial with 12-month f...

Initial Treatment With Lansoprazole in Young Dyspeptic Patients With Negative Urea Breath Test Result: A Randomized Controlled Trial With 12-Month Follow-Up

Although empirical antisecretory drug therapy is recommended to young dyspeptic patients without alarming features, the effectiveness of this approach remains undetermined. We evaluated the long-term effects of an initial 12-wk course of lansoprazole in young dyspeptic patients without Helicobacter pylori (H. pylori) infection. Patients who were less than 45 yr and presented with at least 3 months of dyspepsia in the absence of alarming features were eligible. They were offered (13)C-urea breath test (UBT) to determine H. pylori status and all symptomatic patients with negative UBT were randomized to receive lansoprazole 30 mg daily or placebo for 12 wk. Those who had previous endoscopy or positive UBT were excluded. Primary end point was the proportion of patients with treatment failure, defined as worsening of global dyspeptic symptom, while on study medication. Patients were followed up for 26 wk for global dyspeptic symptom as determined by 7-point Likert scale. Quality-of-life assessment (SF-36), need of endoscopy, and utilization of other health-care services were monitored for 52 wk. A total of 157 dyspeptic patients were randomized. At the end of 12-wk treatment, the proportion of patients with treatment failure was similar in the lansoprazole (33.3%) and placebo (30.3%) groups (P= 0.74). Patients' global assessment of their dyspeptic symptom was comparable at all time points measured. There was also no significant difference in the SF-36 mental and physical summary scales. At the end of 52 wk, there was no difference in the proportion of patients who underwent endoscopy, had additional medical consultations, or used other nonstudy medications between the two groups. Lansoprazole is not effective in the initial management of young dyspeptic patients without H. pylori infection.

Human Milk Vacuolating Cytotoxin A Immunoglobulin A Antibodies ModifyHelicobacter pyloriInfection in Gambian Children

We collected data, including the weights, urea breath test results, and presence of maternal milk cytotoxin-associated gene-specific and vacuolating cytotoxin A-specific immunoglobulin A monthly from 48 mothers and infants (to 44 weeks of age) in The Gambia. In all, 11 children (23%) had negative urea breath test results, and 37 (77%) had positive results. Weight loss associated with Helicobacter pylori colonization was restricted to children whose mothers did not produce anti-vacuolating cytotoxin A antibodies in their milk (P=.028, by t test).

Impact of Helicobacter pylori on the management of dyspepsia in primary care

It is unclear what impact Helicobacter pylori infection has had on the management of dyspepsia in primary care and to what extent published guidelines on H. pylori are implemented in routine clinical practice. To assess the impact of H. pylori infection on the management of dyspepsia in primary care. Patients referred by primary care doctors to an open-access 13-carbon urea breath test service over a 2-year period for their first urea breath test were included in the study. Individual breath results were linked with data on prescribing obtained from the General Medical Services prescription database. Of 805 patients, 374 (47%) had a positive urea breath test and 431 (54%) a negative urea breath test. Of positive urea breath test patients, only 245 (64%) were prescribed eradication therapy in the 3 months after the breath test and only 43% were referred back for re-testing. In the year after the urea breath test, there was a significant fall in prescribing of antisecretory therapy which was greatest in the patients who received H. pylori therapy (P < 0.001). There appears to be under and inappropriate treatment of H. pylori infection in primary care, and a low rate of re-testing after eradication, indicating that current guidelines are not well implemented in practice.

Long‐term follow‐up of 13C‐urea breath test results after Helicobacter pylori eradication: frequency and significance of borderline δ13CO2 values

The precise choice of cut-off point for the 13C-urea breath test to define whether it is positive or negative represents a controversial issue. To quantify the 13C-urea breath test result for several years following Helicobacter pylori eradication, and to evaluate the frequency and the significance of borderline delta13CO2 values. Two-hundred H. pylori eradicated patients confirmed by 13C-urea breath test (100 mg of urea, citric acid), and having had repeated this test yearly up to 5 years, were studied. Delta13CO2 values between 2 and 5/1000 were considered as borderline results. Eight H. pylori recurrences were observed during 406 patient-years of follow-up (1.97% yearly). In two of eight reinfected patients, the reinfection was preceded by a negative delta13CO2 value >2/1000. Borderline delta13CO2 values were detected in 4% of the 606 urea breath tests performed, and in 25% when only patients in whom H. pylori recurrence was detected in subsequent urea breath tests were included (P < 0.05). The negative-predictive value of a post-treatment delta13CO2 >2/1000 for the diagnosis of H. pylori recurrence was 99%. Positive and negative urea breath test results tend to cluster outside the range between 2/1000 and 5/1000. Nevertheless, a borderline urea breath test delta value (e.g. very close to the selected cut-off point) should be interpreted cautiously, and the result should probably be confirmed either by repeating the urea breath test or by other diagnostic methods. On the contrary, a delta13CO2 value <2/1000 very confidently confirms H. pylori eradication.