UMIN-CTR Clinical Trial

Public title

Study of 13C-labeled reagent and continuous 13C breath test device

Acronym

Study of 13C-labeled reagent and continuous 13C breath test device

Scientific Title

Study of 13C-labeled reagent and continuous 13C breath test device

Scientific Title:Acronym

Study of 13C-labeled reagent and continuous 13C breath test device

Region

Japan

Condition

Helicobacter pylori infection and delayed gastric emptying

Classification by specialty

Gastroenterology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Utility of continuous 13C breath test device

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

concordance rate between the results obtained by the conventional measurement system and those obtained by continuous 13C breath test device

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Diagnosis of Helicobacter pylori infection or evaluation of gastric emptying using the continuous 13C breath test device

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients who will undergo 13C urea breath test for the diagnosis of Helicobacter pylori infection in Keio University Hospital

2. Patients who will undergo 13C acetate breath test for the evaluation of gastric emptying in Keio University Hospital

Key exclusion criteria

None

Target sample size

200

Name of lead principal investigator

1st name	Suzuki
Middle name
Last name	Hidekazu

Organization

Keio University School of Medicine

Division name

Division of Gastroenterology and Hepatology, Department of Internal Medicine

Zip code

160-0016

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-5363-3914

Email

hsuzuki@a6.keio.jp

Name of contact person

1st name	Matsuzaki
Middle name
Last name	Juntaro

Organization

Keio University Hospital

Division name

Center for Preventive Medicine

Zip code

160-0016

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-5363-3914

Homepage URL

Email

juntaro.matsuzaki@gmail.com

Institute

Keio University School of Medicine

Institute

Department

Personal name

Organization

TOSHIBA CORPORATION

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Keio University Hospital Clinical and translational research center

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

Tel

03-5363-3503

Email

ctr@info.keio.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

03

Month

05

Day

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000019398&ty

Publication of results

Published

URL related to results and publications

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000019398&ty

Number of participants that the trial has enrolled

71

Results

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.

Results date posted

2020

Year

03

Month

09

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

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.

Participant flow

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.

Adverse events

No adverse events were observed.

Outcome measures

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.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2015

Year

02

Month

23

Day

Date of IRB

2015

Year

02

Month

23

Day

Anticipated trial start date

2015

Year

03

Month

05

Day

Last follow-up date

2017

Year

06

Month

26

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2017

Year

06

Month

26

Day

Other related information

Registered date

2015

Year

03

Month

05

Day

Last modified on

2020

Year

03

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019398