UMIN-CTR Clinical Trial

1.13C acetic acid breath test
In all 13 cases, the data obtained by the conventional method Tmax and the data obtained by the time-series respiratory gas concentration measuring apparatus differed in the Tmax after curve fitting. 

2.13C urea breath test
Forty-two healthy subjects (32 males and 10 females) were enrolled, with 2 positives, 4 gray zones, and 36 negatives. 

1. Gastrointestinal disorders are a group of diseases in which no organic lesions are observed by endoscopy or the like, and symptoms such as heartburn, stomach pain, stomach sagging, diarrhea, and constipation significantly reduce the quality of life of patients. The use of the 13C breath test has recently made it possible to evaluate gastric emptying, which is a cause of functional gastrointestinal disorders. In the conventional 13C breath test method, 13CO2 concentration is measured and gastric emptying is quantitatively measured by taking a breath at regular intervals up to 90 minutes after taking a 13C labeling drug. In this clinical study, 13CO2 concentrations were measured over time using a time-series expiratory gas concentration measurement device that Toshiba Corporation's Production Technology Center is currently developing. We examined whether accurate and quantitative gastric motility evaluation can be performed by this device.

2.It is said that the current infection rate of Helicobacter pylori (H. pylori) in Japan is about 70% for those aged 40 or older, and that there are more than 40 million infected people in total, but the infection rate is decreasing year by year.i , ii. In particular, the number of infected young people is decreasing due to improvements in the sanitary environment, etc., and the infection rate in their 20s is about 10 to 20% ii, x. The urea breath test (UBT), a major test for the diagnosis of H. pylori infection, is a simple, minimally invasive, and highly accurate test method, but requires about one hour of test time i, iv, v, vi . This time, Toshiba Production Technology Center will conduct a test using the time series breath 13CO2 concentration measurement device currently under development by Toshiba Production Technology Center mainly for young people in their 20s, and measure the 13CO2 concentration over time to achieve more accurate and rapid We examined whether a diagnosis of H. pylori infection could be made. In addition, subjects were given an optional questionnaire about the family history of H. pylori infection and the time-series breath 13CO2 concentration measurement device, and the H. pylori infection tendency and the convenience of the time-series breath 13CO2 concentration measurement device among young people in Tokyo. Also conducted a survey.

1. The subjects were patients who obtained consent to participate in both clinical studies, "Evaluation of gastric motility using 13C acetic acid breath test" and "Study on 13C labeling drug and 13CO2 concentration measurement device for breath" at Keio University Hospital. By measuring the 13CO2 concentration using the time series breath 13CO2 concentration measuring device simultaneously with the conventional method, the accuracy of the time series breath 13CO2 concentration measuring device was evaluated in comparison with the 13CO2 concentration measured by the conventional method.

2. For healthy subjects, time-course 13CO2 concentration measurement device is performed by simultaneously measuring 13CO2 concentration using conventional UBT and time-series 13CO2 concentration measurement device and comparing it with 13CO2 concentration measured by conventional equipment. Was evaluated for accuracy.

No adverse events were observed.

1. At Keio University Hospital, Approval number for gastric motility evaluation using 13C acetic acid breath test: 20120251 and "Participation in" Research Approval Number for 13C Labeled Drug and Breath 13CO2 Concentration Measurement Device: 20140411, 13CO2 concentration measurement using a time-series exhalation 13CO2 concentration measurement device
Simultaneously, the accuracy of the time-series expired 13CO2 concentration measurement device was evaluated by comparing with the 13CO2 concentration measured by the conventional method. In addition, the whole data obtained by the measurement device was fitted with a curve and analyzed.

2. For healthy subjects, time-course 13CO2 concentration measurement device is performed by simultaneously measuring 13CO2 concentration using conventional UBT and time-series 13CO2 concentration measurement device and comparing it with 13CO2 concentration measured by conventional equipment. Was evaluated for accuracy. Furthermore, we evaluated whether the diagnosis of H. pylori infection contributed to the reduction of the test time compared to the conventional method by using a time-series 13CO2 concentration measurement device (Keio University School of Medicine ethics committee approval number 20140411). ). In addition, a questionnaire was given to the subjects to investigate the tendency of H. pylori infection in young people in Tokyo and the convenience of a time-series 13CO2 concentration measurement device.