UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000045892
Receipt No. R000052393
Scientific Title Clinical study on the efficacy of H. pylori molecular diagnostic kit. Testing with stool and gastric wash waste.
Date of disclosure of the study information 2021/11/01
Last modified on 2021/10/28 (Ver. 1)

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Basic information
Public title Clinical study on the efficacy of H. pylori molecular diagnostic kit.
Testing with stool and gastric wash waste.
Acronym Clinical study on the efficacy of H. pylori molecular diagnostic kit.
Testing with stool and gastric wash waste.
Scientific Title Clinical study on the efficacy of H. pylori molecular diagnostic kit.
Testing with stool and gastric wash waste.
Scientific Title:Acronym Clinical study on the efficacy of H. pylori molecular diagnostic kit.
Testing with stool and gastric wash waste.
Region
Japan

Condition
Condition Helicobacter pylori infection
Classification by specialty
Hepato-biliary-pancreatic medicine Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the efficacy of the each H. pylori molecular diagnostic kits using stool and gastric wash waste compared with conventional H. pylori diagnostic methods as a control.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes For H. pylori molecular diagnostic kit using gastric wash waste, evaluation of the correlation with H. pylori conventional diagnostic method (urea breath test, stool antigen test, culture) and evaluation of the concordance with clarithromycin antibiotic susceptibility test.
For H. pylori molecular diagnostic kit using stool, evaluation of the sensitivity compared with stool antigen test, and evaluation of the concordance with clarithromycin antibiotic susceptibility test.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who meet all of the following conditions
(1) Patients suspected of H. pylori infection and recommended to undergo endoscopy
(2) Patients who consented to conduct a urea breath test (UBT) and submit stool (stool H. pylori antigen test) before endoscopy
(3) 15 years old and over
Key exclusion criteria Patients who meet any of the following conditions
(1) Patients who did not obtain sufficient samples for the study
(2) Patients who have already received H. pylori eradication treatment
(3) Patients with serious disabilities
(4) Pregnant or potentially pregnant patients
(5) Other patients who the attending physician has determined to be unable to participate in the study
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Mototsugu
Middle name
Last name Kato
Organization National Hospital Organization Hakodate National Hospital
Division name Department of Gastroenterology
Zip code 041-8512
Address 18-16 Kawahara-cho, Hakodate City, Hokkaido, Japan
TEL 0138-51-6281
Email kato.mototsugu.ym@mail.hosp.go.jp

Public contact
Name of contact person
1st name Koichi
Middle name
Last name Ebisu
Organization MIZUHO MEDY Co., Ltd.
Division name R&D Planning Dept.
Zip code 841-0048
Address 5-4 Fujinoki-Machi, Tosu City, Saga, Japan
TEL 0942-85-0301
Homepage URL
Email ebisu@mizuho-m.co.jp

Sponsor
Institute MIZUHO MEDY Co., Ltd.
Institute
Department

Funding Source
Organization MIZUHO MEDY Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hospital Organization Hakodate National Hospital, Ethics Review Boad
Address 18-16 Kawahara-cho, Hakodate City, Hokkaido, Japan
Tel 0138-51-6281
Email 102-kanrikat@mail.hosp.go.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications Unpublished
Number of participants that the trial has enrolled 143
Results For H. pylori molecular diagnostic kit using gastric wash waste, concordance ratio compared with H. pylori conventional diagnostic method were 93.6% for urea breath test, 93.2% for stool antigen test and 97.9% for culture. And concordance rate with clarithromycin antibiotic susceptibility test was 97.0%.
For H. pylori molecular diagnostic kit using stool, sensitivity compared with stool antigen test was 84.2%. And concordance rate with clarithromycin antibiotic susceptibility test was 100%.
Results date posted
2021 Year 10 Month 28 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 143 out of 151 patients enrolled participated (Male 54/Female 89, Median age: 64 with range of 19-90)
Participant flow Obtained informed consent from patients suspected H. pylori infection. 143 out of 151 patients enrolled participated. Participants underwent an conventional H. pylori infection diagnostic method (urea breath test, stool antigen test, culture, antibiotic susceptibility test) and EGD (Esophagogastroduodenoscopy) . Stool and gastric wash waste were collected from the participants. Using the collected samples, evaluation of H. pylori molecular diagnostic kits, real-time PCR method, and sequencing were carried out.
Adverse events No adverse events were observed.
Outcome measures For H. pylori molecular diagnostic kit using gastric wash waste, concordance ratio compared with H. pylori conventional diagnostic method were 93.6% for urea breath test, 93.2% for stool antigen test and 97.9% for culture. And concordance rate with clarithromycin antibiotic susceptibility test was 97.0%.
For H. pylori molecular diagnostic kit using stool, sensitivity compared with stool antigen test was 84.2%. And concordance rate with clarithromycin antibiotic susceptibility test was 100%.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2019 Year 07 Month 31 Day
Date of IRB
2019 Year 09 Month 09 Day
Anticipated trial start date
2019 Year 12 Month 04 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Obtained informed consent from patients suspected H. pylori infection. 143 out of 151 patients enrolled participated. Participants underwent an conventional H. pylori infection diagnostic method (urea breath test, stool antigen test, culture, antibiotic susceptibility test) and EGD (Esophagogastroduodenoscopy) . Stool and gastric wash waste were collected from the participants. Using the collected samples, evaluation of H. pylori molecular diagnostic kits, real-time PCR method, and sequencing were carried out.

Management information
Registered date
2021 Year 10 Month 28 Day
Last modified on
2021 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052393