UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016399 |
|---|---|
| Receipt number | R000019044 |
| Scientific Title | A prospective study about the precision of urinary antibody of Helicobacter pylori in young people |
| Date of disclosure of the study information | 2015/03/20 |
| Last modified on | 2016/12/27 08:30:38 |
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Basic information
Public title
A prospective study about the precision of urinary antibody of Helicobacter pylori in young people
Acronym
Precision of urinary antibody of H.pylori
Scientific Title
A prospective study about the precision of urinary antibody of Helicobacter pylori in young people
Scientific Title:Acronym
Precision of urinary antibody of H.pylori
Region
| Japan |
Condition
Condition
Helicobacter pylori associated gastritis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the precision of urinary antibdy of H.pylori.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate the precision of urinary antibdy of H.pylori in comparison with urea breath test in young people.
Key secondary outcomes
We evaluate the efficasy of urinary antibdy of H.pylori in comparison with serum antibody of H.pylori, serum pepsinogen levels,and serum gastrin levels.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Urea breath test
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
| 16 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients with upper abdominal symptom
2)Healthy volunteers
Key exclusion criteria
1)Past history of H.pylori eradication
2)Past history of gastrectomy
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Inoue |
Organization
Kawasaki Medical School
Division name
Gereral Medicine
Zip code
Address
577, Matsushima, Kurashiki, Okayama
TEL
086-462-1111
inoueki@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Inoue |
Organization
Kawasaki Medical School
Division name
Gereral Medicine
Zip code
Address
577, Matsushima, Kurashiki, Okayama
TEL
086-462-1111
Homepage URL
inoueki@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of General Medicine, Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
川崎医科大学附属病院（岡山県）、福嶋医院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2017 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2017 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 31 | Day |
Last modified on
| 2016 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019044
