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

Abstract

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.

Rabeprazole‐based eradication therapy for Helicobacter pylori: a large‐scale study in Japan

“…Eradication of H. pylori was evaluated based on the results of a 13 C-urea breath test 12 conducted at 6-8 weeks after the completion of eradication therapy in the case of subjects with ulcer scars, and 6-8 weeks after the completion of anti-ulcer therapy following H. pylori eradication therapy in subjects with active ulcers. Breath samples were collected before and 20 min after ingestion of a 100 mg tablet of 13 C-labelled urea, with a level ‡2.5& considered positive for H. pylori infection.…”

Evaluation of the Effects of Strain-Specific Antigen Variation on the Accuracy of Serologic Diagnosis of Helicobacter pylori Infection

“…Biopsy for histological analysis and UBT were performed for all Japanese patients. The UBT was performed as follows: 100 mg of 13 C-labeled urea was given, breath samples were collected before ingestion of the labeled urea and 20 min after ingestion, and the samples were analyzed by mass spectroscopy by using a positive cutoff of 2.5‰ (27). Patients were considered positive for H. pylori infection if either UBT or histology was positive.…”

Personalized treatment in the eradication therapy for Helicobacter pylori

“…In patients infected with HP, urea was decomposed and large amounts of 13 CO 2 were detected in the breath. However, in patients not infected with HP almost no 13 CO 2 appeared in the breath because the urea was not degraded (23).…”