• Korean Journal of Clinical Laboratory Science
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• v.39 no.3
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• pp.271-276
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• 2007

Helicobacter pylori (H. pylori) infection is common in korea and high incidence at gastric ulcer and duodenal ulcer. $^{14}C-urea$ breath test ($^{14}C-UBT$) is regarded as a highly reliable and non-invasive method for the diagnosis of H. pylori infection. The purpose of this study was to evaluate the diagnositc performance of a new and rapid $^{14}C-UBT$, which was equipped with Geiger-Muller counter and compared the results with those obtained by gastroduodenoscopic biopsies (GBx). One hundred sixty-eight patients (M : F = 118 : 50) underwent $^{14}C-UBT$, rapid urease test (CLO test), and GBx. The results of $^{14}C-UBT$ were classified as positive (>50 cpm), borderline (25$^{14}C-UBT$ or CLO test results with GBx as a glod standard. In the assessment of the presence of H. pylori infection, the $^{14}C-UBT$ global performance yielded positive predictive value, negative predictive value and accuracy of 93.3% and 83.3%, respectively. However, the CLO test had performance yielded positive predictive value, negative predictive value and accuracy of 76.9%, 50.0%, respectively. In this study $^{14}C-UBT$ is a highly accurate, simple and non-invasive method or the diagnosis of follow up H. pylori infection.

• The Korean Journal of Nuclear Medicine
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• v.39 no.1
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• pp.21-25
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• 2005

Purpose: $^{14}C$-urea breath test (UBT) is a non-invasive and reliable method for the diagnosis of Helicobacter pylori (HP) infection. In this study, we evaluated the diagnostic performance of a new and rapid $^{14}C$-UBT (Heliprobe method), which was equipped with $Geiger-M\ddot{u}ller$ counter and compared the results with those obtained by using the conventional method. Materials and Methods: Forty-nine patients with dyspepsia underwent gastroduodenoscopy and $^{14}C$-UBT. A 37 KBq $^{14}C$-urea capsule was administered to patients and breath samples were collected. In Heliprobe method, patients exhaled into a Hellprobe BreathCard for 10 min. And then the activities of the BreathCard were countered using Heliprobe analyzer. In the conventional method, results were countered using liquid scintillation counter. During gastroduodenoscopy, 18 of 49 patients were underwent biopsies. According to these histologic results, we evaluated the diagnostic performance of two different methods and compared them. Also we evaluated the concordant and disconcordant rates between them. Results: In all 49 patients, concordant rate of both conventional and Heliprobe methods was 98% (48/49) and the discordant rate was 2% (1/49). Thirteen of 18 patients to whom biopsies were applied, were found to be HP positive on histologic results. And both Heliprobe method and conventional method classified 13 of 13 HP-positive patients and 5 of 5 HP-negative patients correctly (sensitivity 100%, specificity 100%, accuracy 100%). Conclusion: The Heliprobe method demonstrated the same diagnostic performance compared with the conventional method and was a simpler and more rapid technique.

• The Korean Journal of Nuclear Medicine
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• v.35 no.1
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• pp.61-68
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• 2001

Purpose: The C-14 urea breath test (C-14 UBT) is the most specific noninvasive method to detect Helicobacter (H) pylori infection. We investigated if the C-14 UBT can reflect the presence and degree of H. pylori detected by gastroduodenoscopic biopsies (GBx). Materials and methods: One hundred fifty patients (M:F=83:67, age $48.6{\pm}11.2$ yrs) underwent C-14 UBT, rapid urease test (CLO test) and GBx on the same day. For the C-14 UBT, a single breath sample was collected at 10 minutes after ingestion of C-14 urea (137 KBq) capsule and counting was done in a liquid scintillation counter for 1 minute, and the results were classified as positive (${\geq}200dpm$), Intermediate ($50{\sim}199dpm$) or negative (<50 dpm). The results of CLO tests were classified as positive or negative according to color change. The results of GBx on giemsa stain were graded 0 (normal) to 4 (diffuse) according to the distribution of H. pylori by the Wyatt method. We compared C-14 UBT results with GBx grade as a gold standard. Results: In the assessment of the presence of H. pylori infection, the C-14 UBT global performance yielded sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 92.5%, 88.4%, 97.1%, 88.4% and 91.3%, respectively. However, the CLO test had sensitivity, specificity, PPV, NPV and accuracy of 83.2%, 81.4%, 91.8%, 81.4% and 82.7%, respectively. The quantitative values of the C-14 UBT were $45{\pm}27$ dpm in grade 0, $707{\pm}584dpm$ in grade 1, $1558{\pm}584dpm$ in grade 2, $1851{\pm}604dpm$ in grade 3, and $2719{\pm}892dpm$ in grade 4. A significant correlation (r=0.848, p<0.01) was found between C-14 UBT and the grade of distribution of H. pylori infection on GBx with giemsa stain. Conclusion: We conclude that the C-14 UBT is a highly accurate, simple and noninvasive method for the diagnosis of ongoing H. pylori infection and reflects the degree of bacterial distribution.

• Asian Pacific Journal of Cancer Prevention
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• v.14 no.3
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• pp.1797-1802
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• 2013

Background: The aim of this study was to assess clinical factors associated with Helicobacter pylori positivity and to evaluate the incidence of gastric carcinoma in first-degree family members of infected patients. A total of 580 patients (mean age:$38{\pm}17$) with gastrointestinal complaints underwent C-14 urea breath test (UBT). Patients were grouped as: Group-1, untreated patients (n:384); and Group-2, patients who previously treated with eradication triple therapy (n:196). C-14 UBT was performed 1-2 months after the completion of eradication therapy. Associations of H pylori positivity with age, gender, ABO and Rhesus groups, smoking, dietary habits, and history of gastric cancer in first-degree family members were evaluated. The frequency of H pylori positivity was significantly higher in group-1 (58%) compared to group-2 (20%), p=0.001. There were no correlations between H pylori positivity and age, gender, ABO groups, Rhesus subgroups, smoking and dietary habits in both patient groups. The frequency of gastric cancer in family members was significantly higher in patients with H pylori infection among group-1, compared to infected patients among group-2 (56% vs. 28.6% respectively, p=0.03). We observed a significant association between H pylori positivity and the presence of gastric cancer in first-degree relatives of group-1 patients. Our results provide some confirmation of the presence of a link between gastric cancer development and H pylori. C-14 UBT is a sensitive, reliable and a widely recommended test for the detection of H pylori infection and recurrence. We suggest that detection and eradication of H pylori may contribute to a reduced risk of gastric cancer in the family members of infected patients.

• Nuclear Medicine and Molecular Imaging
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• v.42 no.3
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• pp.229-234
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• 2008

Purpose: A urea breath test (UBT) using C-14 or C-13 has been developed for identifying Helicobacter (H) pylori infection on the basis of urease production with release of labeled $CO_2$. We investigated if the C-14 and C-13 UBT have the difference to reflect the presence and degree of H. pylori infection detected by gastro-duodenoscopic biopsies (CBx) in the same patients. Materials and methods: Thirty eight patients (M:F = 28:10, age $53.4{\pm}13.0$ yrs) with upper gastrointestinal symptoms such as indigestion, gastric fullness or pain consecutively underwent C-14 UBT, GBx and C-13 UBT within one week before medications. For the C-14 UBT, a single breath sample was collected at 10 minutes after ingestion of C-14 urea (37 KBq) capsule and counting was done in a liquid scintillation counter for 1 minute, and the results were classified as positive (${\ge}$ 200 dpm), intermediate (50-199 dpm) or negative (50 dpm). For the C-13 UBT, the results were classified as positive (${\ge}2.5\%_{\circ}$) or negative ($<2.5\%_{\circ}$). The results of GBx with Giemsa stain were graded 0 (normal) to 4 (diffuse) according to the distribution of H. pylori by the Wyatt method. We compared C-14 UBT and C-13 UBT results with GBx grade as a gold standard. Results: The prevalence of H. pylori infection by GBx with Giemsa stain was 25/38 (65.8%). In the assessment of the presence of H. pylori infection, the C-14 UBT global performance yielded sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 92.0%, 92.3%, 95.8%, 91.7% and 92.1%, respectively. However, the C-13 UBT had sensitivity, specificity, PPV, NPV and accuracy of 96.0%, 84.6%, 92.3%, 91.7% and 92.1%, respectively. The more significant correlation in C-14 than C-13 UBT (r=0.948 vs r=0.819, p <0.001) was found between the value of UBT and the grade of distribution of H. pylori infection. Conclusion: We conclude that the diagnostic performance between C-14 and C-13 UBT to detect H. pylori infection is not significantly different, but the value of C-14 UBT more significantly reflects the degree of bacterial distribution.

• Korean Journal of Clinical Pharmacy
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• v.22 no.2
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• pp.160-166
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• 2012

Purpose: The purpose of the present study was to investigate the pharmacokinetics of urea, a new potential diagnosis reagent of Helicobacter pylori infection. Methods: Considering the mechanism of urea breath test, we determined the excretion of urea in expired air after its oral administration in rats and beagle dogs at the dose of 2 mg/kg (including 50 mCi/mmol $^{14}C$-urea 50 ${\mu}Ci/kg$ for rats and 13.5 ${\mu}Ci/kg$ for dogs). Results: Urea was rapidly disappeared from the blood circulation by 1 hr after its i.v. bolus injection, followed by a slow disappearance by 24 hr. The half-lives at the distributive phase ($t_{1/2{\alpha}}$) and post-distributive phase ($t_{1/2{\beta}}$) were 2 min and 6 hr, respectively. The bioavailability of urea was 64.3% after its oral administration. The values of the volume of distribution ($V_{dss}$) and the total body clearance ($CL_t$) after the oral administration were compatible with those after i.v. administration. The recovery of urea in the bile was about 0.1% of the dose by 24 hr after its oral administration. Urea was extensively eliminated in the urine by 48 hr. The recovery ratios of urea in the urine and expired air were about 86.8% and 2.99% of the dose by 48 hr, respectively. Moreover, urea was mostly distributed from the blood circulation to the kidney, followed by being eliminated in the urine without metabolism. The concentration of urea in the kidney was 4.0 times higher than that of plasma at 40 min after its oral administration. Conclusions: These findings indicated that oral route appears to be available for the administration of urea. Orally administered urea, thus, was considered to be useful for the diagnosis of Helicobacter pylori infection.

• Asian Pacific Journal of Cancer Prevention
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• v.16 no.10
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• pp.4353-4356
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• 2015

Background: Levofloxacin is an effective medication for second line Helicobacter pylori (H. pylori) eradication. However, limited studies have approved its use as an effective antibiotic in first line therapy. Dexlansoprazole is a new PPI and lacks of evidence in support of a role in H. pylori eradication. This study was designed to evaluate efficacy of levofloxacin-dexlansoprazole-based quadruple therapy for H. pylori eradication in Thailand. Materials and Methods: This prospective randomized control study was performed during June 2014 to December 2014. H. pylori infected gastritis patients were randomized to receive 7- or 14-day levofloxacin-dexlansoprazole based on quadruple therapy (levofloxacin 500 mg OD, dexlansoprazole 60 mg bid, clarithromycin MR 1000 mg OD, bismuth subsalicylate 1048 mg bid). CYP2C19 genotyping and antibiotic susceptibility tests were conducted for all patients. A 13C urea breath test was performed to confirm H. pylori eradication at least 4 weeks after treatment. Results: A total of 100 patients were enrolled, comprising 44 males and 56 females (mean age of 52.6 years). Eradication rate by PP analysis was 85.7% (42/49) with the 7-day regimen and 98% (48/49) with the 14-day regimen (85.7% vs 98%; p-value=0.059). ITT analysis was 84% and 96% with 7- and 14-day regimens, respectively (84% vs 96%; p-value=0.092). Antibiotic susceptibility testing demonstrated 35.1% resistance to metronidazole, 18.3% to clarithromycin, and 13.5% to levofloxacin. CYP2C19 genotyping revealed 54.1% RM, 34.7% IM and 11.2% PM. The 14-day regimen provided 100% eradication in patients with clarithromycin or dual clarithromycin and metronidazole H. pylori resistant strains. Moreover, the eradication rate was 96.6% in patients with CYP2C19 genotype RM. Conclusions: The 14-day levofloxacin-dexlansoprazole based quadruple therapy provides high H. pylori eradication regardless of CYP2C19 genotype, clarithromycin or dual clarithromycin and metronidazole resistant strains. This regimen could be use as an alternative first line therapy for H. pylori eradication in Thailand.

• Asian Pacific Journal of Cancer Prevention
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• v.16 no.14
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• pp.6089-6092
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• 2015

Background: The prevalence of metronidazole-resistant H. pylori is almost 50% in Thailand which severely limits the use of this drug for eradication therapy. The aims of this study were to evaluate the efficacy and safety profiles of 7-day bismuth-based quadruple therapy including metronidazole as an initial treatment for H. pylori infection in a high metronidazole resistance area. Materials and Methods: This study was performed at Thammasat University Hospital and King Chulalongkorn Memorial Hospital during January 2009 to October 2010. Patients with non-ulcer dyspepsia (NUD) with active H. pylori infection were assigned to receive seven days of quadruple therapy (pantoprazole 40 mg bid, bismuth subsalicylate 1,048 mg bid, amoxicillin 1 gm bid and metronidazole 400 mg tid). H. pylori infection was defined as positive H. pylori culture or two positive tests (rapid urease test and histology). Antibiotic susceptibility test for metronidazole by Epsilometer test (E-test) was performed in all positive cultures. At least four weeks after treatment, $^{13}C$ urea breath test ($^{13}C-UBT$) was performed to confirm H. pylori eradication. Results: A total of 114 patients were enrolled in this study, 50 males and 64 females with a mean age of 49.8 years. All 114 patients had a diagnosis of NUD. Overall eradication as confirmed by negative $^{13}C-UBT$ was achieved in 94 out of 114 patients (82.5%). 44 patients had positive cultures and success for E-test. In vitro metronidazole resistance was observed in 22/44 (50%) patients. Eradication rate in patients with metronidazole resistant strains was 16/22 (72.7%) and 20/22 (90.1%) with metronidazole sensitive strains (72.7% vs 90.1%, p-value=0.12; OR=3.75 [95%CI=0.6-31.5]). Minor adverse reactions included nausea, bitter taste, diarrhea and black stools but none of the patients dropped out from the study. Conclusions: Initial treatment with 7-day bismuth-based quadruple therapy including metronidazole, amoxycillin and pantoprazole is highly effective and well tolerated for metronidazole-sensitive H. pylori infections. However, the efficacy markedly decline with metronidazole resistance. Longer duration of this regimen might be required to improve the eradication rate and larger multi-center studies are needed to confirm this hypothesis.

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.22
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• pp.9909-9913
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• 2014

Background: Helicobacter pylori (H. pylori) remains an important cause of gastric cancer and peptic ulcer disease worldwide. Treatment of H. pylori infection is one of the effective ways to prevent gastric cancer. However, standard triple therapy for H. pylori eradication is no longer effective in many countries, including Thailand. This study was designed to evaluate the efficacy of adding bismuth and probiotic to standard triple therapy for H. pylori eradication. Materials and Methods: In this prospective single center study, H. pylori infected gastritis patients were randomized to receive 7- or 14-day standard triple therapy plus bismuth with probiotic or placebo. Treatment regimen consisted of 30 mg lansoprazole twice daily, 1 g amoxicillin twice daily, 1 g clarithromycin MR once daily and 1,048mg bismuth subsalicylate twice daily. Probiotic bacteria composed of Bifidobacterium lactis, Lactobacillus acidophilus and Lactobacillus paracasei. Placebo was conventional drinking yogurt without probiotic. CYP2C19 genotyping and antibiotic susceptibility tests were also done. H pylori eradication was defined as a negative $^{13}C$-urea breath test at least 2 weeks after completion of treatment. Results: One hundred subjects were enrolled (25 each to 7- and 14-day regimens with probiotic or placebo). Antibiotic susceptibility tests showed 36.7% metronidazole and 1.1% clarithromycin resistance. CYP2C19 genotyping revealed 40.8%, 49% and 10.2% were rapid, intermediate and poor metabolizers, respectively. The eradication rates of 7- or 14 regimens with probiotics were 100%. Regarding adverse events, the incidence of bitter taste was significantly lower in the 7- day regimen with the probiotic group compared with 7- day regimen with placebo (40% vs. 64%; p=0.04). Conclusions: The 7-day standard triple therapy plus bismuth and probiotic can provide an excellent cure rate of H. pylori (100%) in areas with low clarithromycin resistance such as Thailand, regardless of CYP2C19 genotype. Adding a probiotic also reduced treatment-related adverse events.

• Asian Pacific Journal of Cancer Prevention
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• v.17 no.10
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• pp.4747-4753
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• 2016

Background: The prevalence of Helicobacter pylori (H. pylori) infection in Indonesia has been reported to be exceedingly low. The purpose of our study was to confirm whether this is the case in Northern Jakarta using a sensitive 13C-urea breath test (UBT), and to examine any associations with lifestyle/environment factors and potential routes of transmission. Methods: We recruited a total of 196 subjects from a low-income community in Northern Jakarta, Indonesia, data from 193 who completed a questionnaire about their lifestyle/environment and had UBT being included as the final. Odds ratios (ORs) adjusted for sex and age with 95% confidence intervals (CIs) were calculated using a logistic regression model. Results: The overall H. pylori infection rate was 15.0% (95%CI, 10.3-20.9), with variation among Javanese (9.1%, total=77), Buginese (40.0%, 35), Betawi (9.1%, 33), Sundanese (3.7%, 27), and Batak (40.0%, 5). On multivariate analysis, the ORs for intake of soybean milk, cucumber more than once a week, infrequent hand washing practice before meals, and alcohol consumption were 0.10 (95%CI: 0.01-0.97), 6.61 (95%CI: 1.87-23.3), 4.10 (95%CI: 1.15-14.6), and 61.9 (95%CI: 1.67-2300.8), respectively. Rates for Buginese (OR=7.84; 95%CI: 1.82-33.8) and Batak (OR=20.1; 95%CI: 1.90-213.2) were significantly higher than for Javanese. Conclusions: The H. pylori infection rate in this study was relatively low, in line with previous studies. Regarding ethnicity factors, Buginese and Batak reported eating food using fingers more frequently than Javanese, Betawi, and Sundanese. Our study indicated that person-person transmission is possible in this low prevalence area. The low infection rates for H. pylori among Javanese, Betawi, and Sundanese ethnics could be partly due to their sanitary practices.