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sstill positive for H.pylori. In the third and fourth (final) run, 197/202 samples (97.52%)and 196/202 samples (97%), respectively, tested positive for H.pylori. The precision of thed13CO2 was 98.6%, 99.2% and 96.7% for the second, third and fourth runs, respectively.Conclusion: One month storage does not affect stability of breath test samples for thediagnosis of H.pylori. Results from repetitive testing of 13CO2 breath samples indicate anoutstanding precision rate.

Su1186

Standard Triple Regimen Eradication Rates for Helicobacter pylori Are CloselyRelated to Clarithromycin Resistance LevelsSpyridon Michopoulos, Evanthia Zampeli, Konstantinos Argyriou, Vassilios Xourafas,Helias Kourkoutas, Iordanis Kissouras, Georgios Kalatzis, Beatriz Martinez-Gonzalez,Dionyssios N. Sgouras, Andreas Mentis

According to Maastricht IV recommendations PPI-clarithromycin-containing triple therapywithout prior susceptibility testing should be abandoned when the regional clarithromycinresistance rate is higher than 15-20% (Grade D). However, this regimen is still administeredeven in areas with high resistance rates. The aim of our study was to determine whetherthe efficacy of classic first line eradication treatment was affected during the last 6 yearsand whether it is influenced by clarithromycin resistance. Methods: Retrospective studyincluded Hp positive patients who received a 10day 1st line treatment {proton pump inhibitorbid+ clarithromycin 500mg bid +amoxicillin 1gr bid} over the period 2008-13. Two periodsduring the past 6 years were compared in terms of eradication success: period A(≤2010)and period B(≥2011). Patients tested with urea breath test (UBT) 4-6 weeks after completionof treatment were analyzed. Clarithromycin resistance was checked by E-test (AB Biodisk,Solna, Sweden) with sensitivity limits >1μg/ml. Results: 848 patients (316men). Age(mean±SD) 53.6±14.2yrs. Period A: 594(219 men) and B: 254 (85 men). Helicobacterpylori's resistance to clarithromycin in adults was stably higher than 20%. Over the past 6years it was almost stable ranging between 22-26% in our population. Eradication ratesaccording to UBT results are shown in the table. The results were not related to gender,age or other demographic parameters. Conclusions: 1) Hp eradication rates are comparablebetween the two periods of the study 2) The low eradication rates (<80%) are relevant tothe high and stable resistance rate to clarithromycin during the study period 3) The admittedlylow success rates raise questions regarding the suitable 1st line treatment given the growingresistance to levofloxacin.

Su1187

Randomised, Multicenter Clinical Trial: Comparison of 10-Day StandardTriple Therapy and Non-Bismuth-Containing Concomitant Therapy forHelicobacter pylori Infection in Korea (Interim Result)Jun Heo, SeongWoo Jeon, Chang-Min Cho, Min Kyu Jung, Jin Tae Jung, Joong GooKwon, Dong Wook Lee, Chang Yoon Ha, Eun Soo Kim, Kyung Sik Park, Si Hyung Lee,Byung Ik Jang

BACKGROUND As a result of increased resistance to antibiotics, Helicobacter pylori (H.pylori) eradication rates with use of standard triple therapy have been declining. Amongthe several new regimens, a concomitant therapy also has been gaining attention as aneffective eradication regimen again. AIM To compare the efficacy and tolerability of a non-bismuth-containing concomitant regimen as first-line treatment of H. pylori infection witha 10 days-standard triple regimen. METHODS A total of 338 Naive H. pylori-infected patientsfrom six hospitals in Korea were randomly assigned to 10 days-standard triple and non-bismuth-containing concomitant therapy groups. 10 days-standard triple regimen consistedof 30 mg of lansoprazole, 1 g of amoxicillin, and 500 mg of clarithromycin, twice daily for10 days. Non-bismuth-containing concomitant regimen consisted of 30 mg of lansoprazole,1 g of amoxicillin, 500 mg of clarithromycin, and metronidazole 500mg, twice daily for 10days. RESULTS The intention-to-treat (ITT) and per-protocol (PP) eradication rates were75.0% and 78.0% in the 10 days-standard triple group, and 84.6% and 89.0% in theconcomitant group, respectively. The eradication rate was significantly higher in the concomi-tant group compared with the standard triple group in both the ITT and PP populations(P = 0.024 and P = 0.009, respectively), whereas the incidence of adverse events was notdifferent. CONCLUSIONS Non-bismuth-containing concomitant therapy is more effectiveand equally tolerated for eradication of H. pylori infection compared to 10 days-standardtriple therapy. Non-bismuth-containing concomitant therapy is thought to be a promisingstandard regimen for H. pylori infection.

Su1189

H. pylori in Peptic Ulcer Bleed: Diagnostic Tests Are Under-UtilizedPhani K. Molakatalla, Anand R. Kumar, Abhishek Gulati, Rohit Nathan, Philip O. Katz

Objective: Helicobacter pylori (H. pylori) infection is a major risk factor for GI bleed froma peptic ulcer. International consensus recommendations for non-variceal upper GI bleedsuggest testing for H. pylori and treating when the test is positive, followed by confirmingits eradication. If a diagnostic test in the acute setting were to be negative, a second testshould be done at follow up. Data on physician compliance with these recommendationsis scarce. Our objectives were to evaluate the frequency of single or dual diagnostic test(s)and the yield of each one of these tests for H. pylori among patients presenting with pepticulcer bleed. Methods: A retrospective chart review of inpatients with an endoscopy confirmedpeptic ulcer bleed at a tertiary medical center between February 2010 and May 2013 wasperformed. Medical records and an internal endoscopy database were reviewed. Various

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diagnostic tests for H. pylori were evaluated. In particular, the use and yield of gastric biopsyin the presence of high risk lesions was examined. Descriptive statistics, proportions andrelative risks (RR), where applicable, were reported. Results: A total of 108 patients (meanage 62 years; 56% males) met the eligibility criteria. High-risk lesions on endoscopy wereseen in 48 (47%) patients and 46 (43%) patients received endoscopic therapy. At least onediagnostic test for H. pylori was performed in 102 (94%) patients. The most common initialtest was biopsy for histopathology (54/108). On a single test (n=102), 50 patients (49%)were found to have H. pylori. Of the remaining 52 patients, a second test was done in only7 (13.5%) cases. Hence, only around 53% of the total patient population met the guidelinerequirements during the study period. The presence of high risk lesions had a higher yield(73% v 35%) for H. pylori on biopsy [RR = 2.10 (1.16-3.84); p<0.01]. However, theendoscopists performed biopsy less often (56% v 83%) in patients with high risk lesions[RR = 0.67 (0.51-0.89); p<0.01]. The yield for H. pylori was the highest with histopathology(chronic active gastritis and/or presence of H. pylori) as shown in table 1. Summary: In thesetting of peptic ulcer bleed, majority got tested for H. pylori. However, severe under-utilization of a second test when the first test was negative reduced our compliance withguidelines. Conclusion: Performing biopsy for histopathology (chronic active gastritis and/or presence of H. pylori) in the presence of high risk lesions is the best test for diagnosisof H. pylori and should be done in all patients with high risk lesions. There is a need toimprove the utilization of available tests in order to increase H. pylori detection and preventrecurrent bleeding.Table1: Diagnostic yield for H. pylori tests

Su1190

Berberine-, Allicin- or Clarithromycin-Based Triple Therapy for the First-LineTreatment of Helicobacter pylori Infection: an Open-Label, Randomized TrialXiaomei Zhang, Yunsheng Yang, Sun Gang, Chao Yang, Mingliang Lu, Junli Zhi

Abstract: Background Clarithromycin-based standard triple therapy for the first-line treatmentof Helicobacter pylori (H. pyloi) has not achieved acceptable eradication rates in some partsof the world, especially in China. This is driven, in part, by clarithromycin resistance. Theplant alkaloid berberine and allicin were known to significantly inhibit proliferation of H.pylori in vitro. Moreover, they also seemed to be potentially effective agent for H. pylorieradication in vivo. Whether berberine or allicin treatment could replace clarithromycin asthe first-line treatment for Helicobacter pylori infection is unknown. We compared theefficacy of berberine-, allicin- or clarithromycin-based triple therapy for 14 days in first-linetreatment. Methods For this single-center, randomized trial, we recruited 336 patients (≥18years old) with H pylori infection from PLA General Hospital between April and December,2013. Using a permuted block randomization with a block size of six, we randomly allocatedeligible patients to receive one of the following regimens (1:1:1): standard triple regimenof clarithromycin 500 mg, omeprazole 20 mg and amoxicillin 1000 mg taken twice a dayfor 14 days; berberine-based triple regimen of berberine, 300 mg 3 times a day and omeprazole20 mg, amoxicillin 1000 mg twice a day for 14 days; or allicin-based regimen of allicin 8mg 3 times a day and omeprazole 20 mg, amoxicillin 1000 mg twice a day for 14 days.Investigators were mask to treatment allocation. Eradication was assessed by 13C urea breathtest at least 1 month after the treatment. Our primary outcome was probablity of H pylorieradication. The prior patients' consent and approval were obtained from Institutional ReviewBoard of the Chinese PLA General Hospital (Number 2013FC-TSYS-1009). Results Weenrolled a total of 336 participants: 112 to each group. In the intention-to-treat population,H. pylori eradication rate was higher with berberine-based therapy (80.4%, 95% CI 73.0-87.7) than with standard-based therapy (67.0%, 95% CI 58.3-75.7) and allicin-based ther-apy(65.2%, 95% CI 56.4-74.0). In the per-protocol population, eradication rate was 70.8%(95% CI 62.1-79.4; 75 of 106 patients) in standard triple therapy, 84.1% (95% CI 77.2-91.0; 90 of 107 patients) in berberine-based therapy, and 73% (95% CI 64.3-81.7; 73 of100 patients) in allicin-based therapy. Safety profiles for each treatments was similar and mainadverse events were gastrointestinal disorders. Conclusion Berberine-based triple regimen(berberine, amoxicillin and PPI) can achieve a > 80% ITT success rate with similar safetyand tolerability to standard regimen for first-line treatment of H. pylori infection.

Su1191

Efficacy of Sequential Therapy for Eradication of Helicobacter pylori All Overthe Word. Lessons From a Comparative Meta-AnalysisLuigi Gatta, Dino Vaira, Carmelo Scarpignato

Background: Thanks to the increasing prevalence of clarithromycin and metronidazole resis-tance, the eradication rates of Helicobacter pylori infection have substantially decreased inrecent years. As a consequence, novel eradication regimens have been proposed in theattempt to overcome antimicrobial resistance. Sequential therapy (ST), a regimen givingantimicrobials (with proton pump inhibitors) in sequence rather than all simultaneously,was first studied in Italy and Europe and subsequently in other Continents. Aim: To evaluatewhether efficacy of ST in Europe is similar in other Continents a systematic review andmeta-analysis of the available studies were performed. Methods: MEDLINE, EMBASE, theCochrane Central Register of Controlled Trials as well as abstract from the Digestive DiseaseWeek, the American College of Gastroenterology Meeting, the United European Gastroentero-logical Week and Asian Pacific Digestive Week were searched up to May 2013 for RCTs

comparing sequential therapy with established and new treatments. The proportion ofindividuals eradicated with ST was combined from all studies to give a pooled eradicationrate using a random effect model in order to provide a more conservative estimate. Resultsare summarized in Table 1. Conclusions: Eradication rates with ST are similar in Europe,Asia and Africa. The lower rates observed in South America are mirrored - in the comparativetrials - by similarly lower success rates of other regimens (namely triple or concomitanttherapies), likely reflecting the higher prevalence of antimicrobial resistance.

Su1192

A Follow-Up of CDX1 and CDX2 mRNA Expressions in Noncancerous GastricMucosae After Helicobacter pylori EradicationCheol Min Shin, Nayoung Kim, Hyun Chang, Joo Sung Kim, Dong Ho Lee, Hyun ChaeJung

Objectives: To evaluate the changes in CDX1 and CDX2 expressions after Helicobacter pylorieradication, in relation to the reversibility of intestinal metaplasia (IM). Methods: Timecourse of CDX1 and CDX2 expressions was investigated in 107 successfully H. pylorieradicated, 25 non-eradicated and 44 H. pylori negative subjects, including 82 controls, 51with gastric dysplasia and 43 with early gastric cancer. All dysplasia and gastric cancerpatients underwent endoscopic resection at the time of enrollment. Expression levels inCDX1 and CDX2 from noncancerous gastric mucosae of corpus, as well as the histologicfindings of gastric mucosae, were evaluated during the follow-up. Results: Average follow-up duration was 33.6 months (range: 2 to 97 months). Expression levels in both CDX1and CDX2 mRNAs were significantly correlated with IM grade in corpus (ρ = 0.633 and0.554, respectively, all P < 0.001). Profiles of CDX1 and CDX2 mRNA expression followingH. pylori eradication showed only insignificant results. IM grade in antrum and corpusshowed a trend toward decrease after H. pylori eradication without statistical significance(P > 0.05). Interestingly, histologic improvement of IM at corpus was found to be correlatedwith a decrease in CDX2 mRNA expression, but not in CDX1. Conclusion: In this study,eradication of H. pylori did not show beneficial effects on aberrant CDX1/CDX2 expressionsor IM. However, at least a portion of subjects showed a histologic improvement in IMirrespective of H. pylori eradication, and reversibility of IM at corpus appeared to be associatedwith a decrease in CDX2 mRNA expression.

Su1193

Efficiency of Eradication Therapy in Patients With Autoimmune GastritisAssociated With Helicobacter pylori: A Prospective StudyOleg A. Sablin, Maxim Yurin, Natalia Zakharova, Vladimir Simanenkov

Aim: To assess the efficacy of eradication therapy in patients with mixed-gastritis (autoim-mune gastritis associated with Helicobacter pylori (Hp)) for prevention of preneoplasticchanges in gastric mucosa. Methods: A total of 97 patients with mixed-gastritis and 109patients with Hp -associated gastritis were investigated. All patients underwent upper endos-copy with biopsy of gastric mucosa, histological assessment of biopsy specimens, diagnosticsof Hp-infection (rapid urease test, PCR-based detection in biopsy material, determinationof serum levels of IgG), identification of antibodies to parietal cells and also identificationof pepsinogen I (PGI), pepsinogen II and gastrin-17. Assessment was performed before andone and two years after 10-day eradication therapy containing omeprazole 40 mg/day,clarithromycin 1 g/day and amoxicillin 2 g/day. Results: It was identified that the efficacyof eradication therapy after one year was 71.4% in patients with mixed-gastritis, while inpatients with Hp-associated gastritis it was less - 60.7 % (p<0.05). Decrease of averageserum IgG level from 84.3 to 49.1 EIU (p<0.001) was peculiar to patients with Hp-associatedgastritis one year after the effective eradication, while decrease of average IgG level to 51.4EIU (p<0.001) in patients with mixed-gastritis after effective eradication was observed onlyafter two years. Average level of IgG one year after the effective eradication in patients withmixed-gastritis was still high - 110.5 EIU. Antibody level to parietal cells in patients withmixed gastritis after ineffective eradication increased from 28.2 to 35.4 U/ml (p<0.05) afterthe first year and up to 51.4 U/ml after the second year (p<0.05). An increase from 29.6to 34.7 U/ml (p<0.05) was also observed in patients with effective eradication after the firstyear but after the second year there was a decrease to 25.5 U/ml. Antibodies to parietalcells in patients with mixed-gastritis disappeared in 14.2% cases two years after the successfuleradication. The average serum PGI level definitely decreased one year after the effectiveeradication from 88.7 to 66.7 mcg/l in patients with mixed-gastritis and from 115.5 to 84.5mcg/l in patients with Hp-associated gastritis (p<0.05) and remained the same two yearsafter. PGI decreased due to reduction of inflammatory changes in the gastric corpus mucosa,while severity of mucous atrophy did not change as confirmed by histological examination.Conclusion: The dynamics of serum level of IgG to Hp after the effective eradication inpatients with mixed-gastritis can be characterized by a slower decrease than in patients withHp -associated gastritis. After successful eradication serum PGI level decreases in patientswith mixed-gastritis due to reduction of inflammatory changes in the gastric corpus mucosaand it really reflects the severity of its atrophy.

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Su1194

Sequential Therapy Is Not Better At Eradication of Primary Helicobacter pyloriInfection When Compared to Standard Triple Therapy in the United States-aProspective, Randomized Evaluation in a United States PopulationElizabeth Coss, Robert M. Genta, Kerry B. Dunbar, Christina Park, Nicholas S. Rogers,Byron L. Cryer

Background-Helicobacter pylori (H. pylori) infection remains the most common chronicbacterial infection in humans and its treatment is increasingly challenging in an era ofantibiotic resistance. The recommended treatment for H. pylori is standard triple therapy(STT). Clinical efficacy of STT is estimated to be around 50% and eradication failure isthought to be a result of antibiotic resistance, particularly to clarithromycin. Studies suggestthat sequential therapy (SQT) can provide eradication in 95% of patients and new Europeanguidelines advocate treatment of H. pylori with SQT rather than STT given high clarithro-mycin resistance rates. Design-We are conducting a single-center, prospective, randomizedevaluation of STT versus SQT in a US patient population. Patients with H. pylori infectionconfirmed by urea breath testing followed by endoscopic gastric biopsies were randomizedto STT (amoxicillin 1gm bid, clarithromycin 500mg bid, and omeprazole 20mg bid orallyfor 10 days) or SQT (amoxicillin 1gm bid and omeprazole 20mg bid for 5 days followedby clarithromycin 500mg bid, metronidazole 500mg bid, and omeprazole 20mg bid foranother 5 days). Breath testing was performed 4 weeks after completion of treatment toconfirm H. pylori eradication. We anticipate that 168 subjects will need to have completedtreatment for this trial to be sufficiently statistically powered to answer the question ofcomparative efficacy of the two treatment arms. Currently, 128 subjects have completedtreatment, approximately 75% of the patients needed per our sample size calculation. Results-The mean age of the 128 treated patients is 60.6 years old (range 28-85 years). They are87% male and 42.1% Caucasian. Overall, 88% of patients achieved eradication (113/128).Of these 128 patients, 66 patients were in the sequential group (SQT) and 62 were in thestandard therapy (STT) group. In ITT analysis, eradication rates were 78% (56/72) in theSQT group vs 74% (57/77) in the STT group. In the PP analysis, eradication rates were90.4% (56/62) for the SQT group vs 86.4% (57/66) for the STT group. The calculatedfailure rate for SQT is 9.6% and 13.6% for STT. The difference between failure rates is only4% (p=0.59), a much lower failure rate than previously reported in the literature. Based ondata from our interim analysis, in order to detect a significant difference between SQT andSTT, an additional 1449 patients would need to be recruited into each arm to detect theminimal difference seen between therapies. Conclusions-Despite studies in Europe suggestingthat SQT is better than STT at treatment of H.pylori, analysis of our data suggests that STTis comparable to SQT and still a good option for treatment of primary H. pylori infectionin the US. We target that the study will be fully enrolled and complete analysis availableby March 2014.

Su1195

Geographical Difference in Primary Antimicrobial Resistance Pattern ofHelicobacter pylori Clinical Isolates From Taiwan Patients During 2008-2013:Multicentric StudyHuang-Ming Hu, Chi-Hsing Ou, Fu-Chen Kuo, Yen-Hsu Chen, Lin-Li Chang, Chao-Hung Kuo, Deng-Chyang Wu

Background: The resistance of Helicobacter pylori (H. pylori) to antibiotics is increasingworldwide, affecting the efficacy in current eradication therapies. The objectives of this studywere to assess local data regarding the susceptibility of the antibiotics most frequently usedfor the eradication of H. pylori in different area in Taiwan. Methods: A total of 824 H.pylori isolates from 1564 patients undergoing upper gastrointestinal endoscopy at fivehospitals in Taiwan between 2008 and 2013 were enrolled. The resistances of antibiotics(amoxicillin (AMX), clarithromycin (CLA), tetracycline (TET), levofloxacin (LEV) and metro-nidazole (MTZ)) were determined by the Epsilometer test. Results: Of the 824 H. pyloristrains, the resistance rates of amoxicillin, clarithromycin , metronidazole, tetracycline andlevofloxacin were 0.7%, 12.6%, 29.9%, 0.2%and 18.2%, respectively. The resistance ratesof metronidazole and levofloxacin in northern Taiwan (19.7% and 6.9%, respectively) weresignificantly lower than that in eastern Taiwan (40.7% and 18.5%, respectively) and southernTaiwan (31.4% and 21.6%, respectively). The resistance rate of levofloxacin was significantlyhigher in isolates collected during 2011-2013 than in those during 2008-2010(21.7% vs.10.6%). Conclusion: Clarithromycin-based triple therapy remains an appropriate first-lineH. pylori eradication regimen in Taiwan because of the stably low primary clarithromycinresistance. The increasing resistance of levofloxacin would be a serious problem, especiallyin eastern Taiwan and southern Taiwan.

Su1197

High Resolution Melt Curve Assay for the Detection of Point MutationsAssociated With Helicobacter pylori Resistance to ClarithromycinTsachi Tsadok Perets, Einav Shporn, Dalal Hamouda, Ram Dickman, Haim Shmuely,Filipa F. Vale, Yaron Niv

Background: The prevalence of Helicobacter pylori (HP) resistance to clarithromycin isincreasing continuously contributing to treatment failure. Clarithromycin resistance is attrib-uted to three point mutations (PM): A2142C, A2142G and A2143G within the peptidyl-transferase region of the 23 S rRNA gene. Aim: To develop a fast and accurate method forthe detection of the three point mutations responsible for HP resistance to clarithromycin.Methods: Study sample included 85 HP isolates, obtained from patients with dyspepsia. HPDNAs extracted from the isolates were analyzed using the high resolution melt (HRM) curveanalysis. The DNAs extracted were compared to 4 reference plasmids that incorporate thethree mutations and the wild type (WT) sequences. Results: There was a perfect correlationbetween the HRM results and the 85 positive isolates - all were positive using the HRManalysis. Of the 85 isolates, 18 had a WT sequence (21.2%), and 67 (78.8%) contained a23 S rRNA PM. Of the 67 isolates that include 23 S rRNA PM, 18 had an A2142G PMsequence (26.8%), 22 had an A2142C PM sequence (32.8%) and 27 had an A2143G PM

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