UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effective use of Drinking-Ultrasonography for the diagnosis of Helicobacter pylori-associated dyspepsia
Title of the study (Brief title)	Drinking-Ultrasonography for Helicobacter pylori-associated dyspepsia
Region	Japan

Condition
Condition	Helicobacter pylori-associated dyspepsia
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate whether Drinking-Ultrasonography Test is effective for the early diagnose of Helicobacter pylori-associated dyspepsia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Calculate the correct diagnosis rate of Helicobacter pylori-associated dyspepsia with sensory hypersensitivity by Drinking-Ultrasonography Test at 2 months, 6 months to 1 year after eradication
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)Persons whose age is 20 years or older at the time of acquiring consent 2)Helicobacter pylori infected patients 3)The patients who will perform eradication therapy 4)Persons who have recorded GSRS (Gastrointestinal Symptom Rating Scale) and GOS (Global Overall Severity) that evaluate abdominal symptoms before eradication 5)The patients who will perform upper gastointestinal endoscopy before eradication 6)The patients who will perform Drinking-Ultrasonograhy Tet before eradication 7)Patients from whom written informed consent is obtained.
Key exclusion criteria	1)The patients who have allergic to eradication drugs 2)The patients with organic disease in the stomach 3)Patients who are judged as being inappropriate for this study by their medical doctor
Target sample size	48

Research contact person
Name of lead principal investigator	Shoko Ono
Organization	Hokkaido University Hospital
Division name	Division of Gastroenterology and Hepatology
Address	Kita 14, Nishi 5, Kita-ku, Sapporo
TEL	011-716-1161
Email	onosho@med.hokudai.ac.jp

Public contact
Name of contact person	Momoko Tsuda
Organization	Hokkaido University Hospital
Division name	Division of Gastroenterology and Hepatology
Address	Kita 14, Nishi 5, Kita-ku, Sapporo
TEL	011-716-1161
Homepage URL
Email	momoko0221tsuda@gmail.com

Sponsor
Institute	Hokkaido University
Institute
Department

Funding Source
Organization	Self-sourcing
Organization
Division
Category of Funding Organization	Other
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	2018 Year 10 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 08 Month 27 Day
Anticipated trial start date	2018 Year 08 Month 27 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	Unpublished
URL releasing results
Results
Other related information	Exploratory prospective study to conduct Drinking-Ultrasonography Test before and after eradication

Management information
Registered date	2018 Year 09 Month 28 Day
Last modified on	2018 Year 09 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039096