Validation of the 13C-urea breath test for the diagnosis of helicobacter pylori infection in children: a multicenter study
Franco BazzoliLuca CecchiniLuigi CorvagliaMartino Dall’AntoniaC. De GiacomoS. FossiL Gobio CasaliS. GulliniR LazzariG LeggeriP. LerroV. ValdambriniG. MandrioliMiris MaraniP. MartelliAngelo MianoGianni NicoliniGiuseppina OderdaP. PazziP. PozzatoLuigi RicciardielloEnrico RodaPatrizia SimoniS. SottiliGiuliano TorreLoredana UrsoRocco Maurizio Zagari
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Abstract:
The 13C-urea breath test (13C-UBT) is a safe, noninvasive, and accurate test for the detection of Helicobacter pylori (H. pylori) infection in adults. The aim of this study was to evaluate sensitivity and specificity of 13C-UBT in children using different types of test meal, doses of 13C-urea and breath sampling intervals. As yet, a validated, standardized 13C-UBT protocol for children has not been formulated.13C-UBT was performed in 115 children and repeated within 3 days, modifying the test meal or the dose of 13C-urea. H. pylori status was assessed by histology and rapid urease test. 13C-UBT was performed using 100 mg or 50 mg of 13C-urea and a fatty test meal (100 FA; 50 FA), 50 mg of 13C-urea, and a carbohydrate test meal (50 CA). Breath samples were collected every 10 min for 60 min.The 13C-UBT in children was highly sensitive and specific with all three protocols used. The best combination of sensitivity (97.92%) and specificity (97.96%) was obtained with Protocol 50 FA at 30 min with a cut-off of 3.5 per mil.The 13C-UBT is an accurate test for the detection of H. pylori infection also in children. Administration of 50 mg of 13C-urea, a fatty test meal, and breath sampling at 30 min appears to be the most convenient protocol.Keywords:
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SUMMARY Helicobacter pylori infection has proven to be extraordinarily difficult to eradicate. Antimicrobial monotherapies have been particularly disappointing, with most eradication rates in the range of 0 to 15%. We evaluated cefprozil (250 mg q.d.s. for 14 days) in 12 H. pylori ‐infected subjects. The 13 C‐urea breath test was used to evaluate effectiveness of therapy. Eradication was defined as a negative urea breath test 4 to 6 weeks after the end of treatment. Suppression of H. pylori was demonstrated in 4 of 12 (33%) by a negative urea breath test two days after start of treatment. H. pylori infection was not eradicated in any subject (0%). Adverse events were intermittent and mild. Cefprozil does not appear to offer promise as monotherapy for the eradication of H. pylori .
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Sixty-five-years or older person accounts for 23% of the population in Japan. Hence, Helicobacter pylori (H. pylori) eradication therapy is performed in many elderly patients. Urea breath test and H. pylori stool antigen test for diagnosis of H. pylori infection before and after eradication therapy are recommended from the point of being a noninvasive test and providing accurate diagnosis. H. pylori eradication therapy in Japan consists of the PPI/AMPC/CAM as the first therapy, and PPI/AMPC/MNZ as the second therapy. Eradication therapy rate and adverse effect rate of H. pylori eradication therapy for elderly patients are the same as for young people. It is not necessary to avoid H. pylori eradication therapy merely because of high age in elderly patients. However, it is necessary to be careful regarding drug interactions in patients who are taking multiple drugs.
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To determine the utility of the [13C]urea breath test in confirming the eradication of Helicobacter pylori.We reviewed our H. pylori database for patients who underwent [13C]urea breath test at baseline and 6 wk after triple therapy with tetracycline, metronidazole, and bismuth subsalicylate. Baseline infection was defined by the identification of the organism on antral biopsies or a reactive CLO test. Eradication was defined as a negative Warthin-Starry stain and a non-reactive CLO test at 24 h. All patients had a positive baseline [13C]urea breath test defined as [13C] enrichment > 6% at 60 min.One hundred eighteen H. pylori-infected patients (mean age 58.3 +/- 13.9 yr) met the review criteria (61 duodenal ulcers, 24 gastric ulcers, 33 non-ulcer dyspepsia). In 101/118 patients (86%), H. pylori was successfully eradicated (mean baseline breath test value 25.8 +/- 1.6). Of 101 patients, 95 had a negative 6-wk follow-up breath test (mean 2.2 +/- 0.2, p < 0.001). Of the 6/101 patients in whom treatment was successful, and who remained breath test positive at 6 wk, 4/6 were breath test negative when retested at 3 months. The remaining two patients were lost to follow-up. In 17/118 (14%) patients, H. pylori failed to be eradicated (mean baseline breath test 22.4 +/- 3.6). Fifteen of 17 patients had a positive breath test at 6 wk (mean 19.9 +/- 3.7). Two of 17 with a negative breath test at 6 wk tested positive when the breath test was repeated at 3 months. The sensitivity and specificity of [13C]urea breath test at 6 wk posttreatment are 97% and 71%, respectively. The positive and negative predictive values are 94% and 88%, respectively.[13C]urea breath test is a sensitive indicator of H. pylori eradication 6 wk after treatment. Antral biopsies are unnecessary to confirm eradication of H. pylori after completion of treatment.
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Helicobacter pylori infection is the most common gastrointestinal bacterial disease worldwide. Although using culture is considered as the golden standard method for diagnosis of H. pylori infection, urea breath test is a notable alternative method because it is an easy, quick, and non-invasive approach. The aim of this study was to estimate the prevalence of H. pylori infection in patients with digestive discomforts using urea breath test in Mashhad County, northeast of Iran.The study involved 814 patients, 467 women and 347 men, aged 17-80 years, with gastrointestinal symptom from January 2007 to November 2008. The urea breath test was performed and the patients ingested a solution of isotope labeled urea. The expired air was collected and was analyzed using the Heliprobe breath card (Noster System, Stockholm, Sweden).The results of the test were positive for 698 out of 814 (85.75%) patients including 403 (86.30%) of women and 295 (85.01%) of men. However, the difference between the two groups was not statistically significant. Positive cases were classified by age. The highest prevalence rate of H. pylori infection was observed among 50-60 years old patients.The infection of H. pylori is very common among patients who have gastric complain and can be easily diagnosed by noninvasive urea breath test. Since H. pylori infection is related to poor prognosis outcomes such as gastric cancer. Therefore, screening and treatment of infected people especially symptomatic cases using urea breath test is a priority.
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There are an estimated 60 million people with Helicobacter pylori(H. pylori) infection who occupied 50% of the population of Japan. In Japanese medical reimbursement H. pylori tests were introduced on November 1, 2000 and they are able to use only to patients with gastric and duodenal ulcer. H. pylori tests were composed of rapid urease test, urea breath test, antibody test, bacterial culture and pathologic test. Payment of each test is 700 Yen. Classification and cost of H. pylori tests are shown. Usage of laboratory tests for H. pylori infection is mentioned. Those particular tests are useful to decrease the number of gastric and duodenal ulcer in Japan.
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Helicobacter pylori eradication therapy is useful and requires more precise determination of actual eradication. Patients often become positive for Helicobacter pylori again after presumed eradication. Reinfection is thought rare and patients with positive reconversion may be false-negative at determination. After a year, positive reconversion was 26.8% in our work after determination by culture and histopathological methods and 4.3% after these were combined with urea breath test (UBT). The positive reconversion rate is significantly lower after combination with UBT, suggesting the usefulness of UBT in determining Helicobacter pylori eradication. This may be because UBT includes no biopsy, eliminating sampling error, and highly sensitive UBT detects traces of Helicobacter pylori. The UBT is thus expected to become widely used to determine Helicobacter pylori eradication.
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This was a descriptive study carried out from January to December 2021, at Quanzhou First Hospital, an affiliated hospital of Fujian Medical University, to investigate the efficacy of the urea breath test in detecting Helicobacter pylori infection in patients with peptic ulcer bleeding affected with proton pump inhibitors. A total of 77 patients with peptic ulcer bleeding, who underwent urea breath testing after active bleeding, were divided into two groups. The Helicobacter pylori infection positivity rate in patients with peptic ulcer bleeding was 66.2%. The time from bleeding to detection and from admission to detection was not significantly different between the Helicobacter pylori-positive and -negative groups (p=0.840 and 0.285, respectively). Even with high-dose proton pump inhibitor treatment, a urea breath test can be performed after peptic ulcer bleeding ceases and results in an acceptable positivity rate. There was no significant difference in the accuracy of Helicobacter pylori detection between the time from bleeding to testing and from admission to testing. Key Words: Peptic ulcer, Helicobacter pylori, Upper gastrointestinal bleeding, Urea breath test, Proton pump inhibitor.
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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.
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Objective To explore the clinic value of breath-card method[KG-1mm] ~(14)C-urea breath test in diagnosis of Helicobacter pylori infection. Methods The samples were taken from subjects with empty stomach or 3 hours after eating,gargling and taking a[KG-1mm] ~(14)C-Urea capsule orally,waiting for 15 min and then breathing the breath-card for a duration of 2 to 5 min till the screen changed from blue to white.Totally 520 out of the 1507 patients were examined by gastroscope. Results The total positive rate was 42.66%,re-examination positive rate was 17.95%.The positive rates of peptic ulcer,gastritis and gastric carcinoma in the 520 patients examined by gastroscope were 91.91%,76.42% and 62.07% respectively. Conclusion The breath-card method ~(14)C-Urea breath test is a useful method for diagnosis of Helicobacter pylori infection.
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