UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	examination of the Helicobacter pylori detection of the antigen kit among Helicobacter pylori services using irrigation water in the stomach in the endoscopy
Title of the study (Brief title)	examination of the Helicobacter pylori detection of the antigen kit among Helicobacter pylori services using irrigation water in the stomach in the endoscopy
Region	Japan

Condition
Condition	Helicobacter pylori gastritis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We determine the Helicobacter pylori detectability of the antigen kit of feces using irrigation water in the stomach in the endoscopy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of agreement with "irrigation water in the stomach" in the antigen during the Helicobacter pylori service and "feces"
Key secondary outcomes

Base
Study type	Interventional

Study design
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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	1)For the subject patient who came to the hospital, we acquire an agreement in a document about the participation in this study and register ourselves. 2)We carry out endoscopy upper gastrointestinal tract and make entry of endoscopic findings and degree of the mucosa atrophy, others need matter in a case report. 3)We collect irrigation water in the stomach at endoscopy and we use an antigen kit during the Helicobacter pylori service and judge it. 4)We collect feces and judge it using an antigen kit during the Helicobacter pylori service. 5)All results explain a test result in the foreign consultation of the patient after revelation.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)The patient who carried out an endoscopy 2)At the agreement acquisition age more than 20 years old 3)The patient that a document agreement was obtained about participation of this study
Key exclusion criteria	1)The patient who performed Helicobacter pylori sanitization treatment in the past 2)We are the patients within four weeks after during the sanitization medicine taking or taking end 3)We are the patients within two weeks after during the medicine (proton pump inhibitor) taking having bacteriostatic action or taking end 4)When a clear loss is found in a stomach 5)When a vomiting reflex in the endoscopy is strong 6)A case of Performance status 1-4 7)A case of ASA classification 3- 8)In addition, when doctor attending intended for it and admitted that we were inadequate
Target sample size	24

Research contact person
Name of lead principal investigator	Koichiro Kawano
Organization	Hyogo Prefectural Awaji medical center
Division name	Department of gastroenterology
Address	1-1-137Shioya, Sumoto-city, Hyogo
TEL	0799-22-1200
Email	toranoana18@hotmail.com

Public contact
Name of contact person	Koichiro Kawano
Organization	Hyogo Prefectural Awaji medical center
Division name	Department of gastroenterology
Address	1-1-137Shioya, Sumoto-city, Hyogo
TEL	0799-22-1200
Homepage URL
Email	toranoana18@hotmail.com

Sponsor
Institute	Hyogo Prefectural Awaji medical center
Institute
Department

Funding Source
Organization	Wakamoto Pharmaceutical
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	2016 Year 10 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 28 Day
Anticipated trial start date	2016 Year 10 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 10 Month 11 Day
Last modified on	2018 Year 10 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026417