Studies of 13C-urea breath test for diagnosis of Helicobacter pylori infection in Japan.

In recent years Helicobacter pylori infection has been implicated in the etiology of a variety of upper gastrointestinal diseases. The aim of this multi-center trial was to search for the cut-off value of the simple 13C-urea breath test (13C-UBT) for diagnosis of H. pylori infection, and to examine...

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Publicado en:Journal of Gastroenterology Vol. 33; no. 1; pp. 6 - 14
Autores principales: Ohara, S, Kato, M, Asaka, M, Toyota, T
Formato: clinical trial research Journal Article
Publicado: Springer Nature 1998
Acceso en línea:Ver este registro en EBSCOhost
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        09441174
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      dt: 1998
      vid: 33
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      pub: Springer Nature
      place: New York, New York
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        10.1007/pl00009968
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        138750365
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        atl: Studies of 13C-urea breath test for diagnosis of Helicobacter pylori infection in Japan.
      aug:
        au:
          Ohara, S
          Kato, M
          Asaka, M
          Toyota, T
        affil: C-13UBT Study Group, Third Department of Internal Medicine, Tohoku University School of Medicine, Miyagi, Japan
      sug:
        subj:
          Urea Metabolism
          Helicobacter Infections Diagnosis
          Helicobacter Pylori
          Gastrointestinal Diseases Diagnosis
          Breath Tests Methods
          Gastrointestinal Diseases Microbiology
          Helicobacter Infections
          Urease Metabolism
          Female
          Helicobacter Infections Microbiology
          Male
          Japan
          Middle Age
          Aged
          Human
          Gastrointestinal Diseases
          Endoscopy, Gastrointestinal
          Adult
          Isotopes
          Clinical Trials
          Validation Studies
          Comparative Studies
          Evaluation Research
          Multicenter Studies
          Middle Aged: 45-64 years
          Aged: 65+ years
          Adult: 19-44 years
          Female
          Male
      ab: In recent years Helicobacter pylori infection has been implicated in the etiology of a variety of upper gastrointestinal diseases. The aim of this multi-center trial was to search for the cut-off value of the simple 13C-urea breath test (13C-UBT) for diagnosis of H. pylori infection, and to examine the sensitivity and specificity of 13C-UBT for culture, the rapid urease test (CLO test), histology, and serological tests. Two hundred and forty-eight patients participated in this study after giving their informed consent. Endoscopic biopsy specimens were taken from gastric antrum and corpus for culture (190 patients), CLO test (222 patients), and histology (98 patients). A serological test was carried out for all patients. H. pylori infection was established when culture was positive or more than two of the tests, histology, CLO test, and serological test, were positive, and non-infection status was established when the all tests more than two tests were negative. After baseline breath samples were taken, the patients (who had fasted) were given 100mg of 13C-urea in 100ml water while sitting; they washed out the mouth with water. They were then placed in the left lateral decubitus position for 5 min, and additional breath samples were taken 10, 20, 30, 45, and 60 min after urea administration, with patients in the sitting position. One hundred and sixty-five of the 248 patients were infected, 48 were not infected, and H. pylori infection status was not evaluated in 35 by endoscopic and serological tests. Breath samples at 20 min were employed to determine the cut-off value. Using the receiver operating characteristic (ROC) curve, we determined the cut-off value for a positive UBT at 2.5 delta per thousand. The sensitivities of UBT for culture, CLO test, histology, and serological test were 98.4%, 98.6%, 100.0%, and 92.5%, and the specificities were 78.8%, 82.5%, 83.3%, and 87.3%, respectively. The cut-off value of 13C-UBT for the diagnosis of H. pylori infection was 2.5 delta per thousand; this test is a simple and noninvasive method for the diagnosis of this infection and has high sensitivity and specificity.
      pubtype: Academic Journal
      doctype:
        clinical trial
        research
        Journal Article
      ougenre: Article
    language: English
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