UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017897 |
|---|---|
| Receipt number | R000020737 |
| Scientific Title | Helicobacter pylori eradication therapy for the junior high school students |
| Date of disclosure of the study information | 2015/06/13 |
| Last modified on | 2019/01/14 15:33:42 |
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Basic information
Public title
Helicobacter pylori eradication therapy for the junior high school students
Acronym
Helicobacter pylori eradication therapy for the junior high school students.
Scientific Title
Helicobacter pylori eradication therapy for the junior high school students
Scientific Title:Acronym
Helicobacter pylori eradication therapy for the junior high school students.
Region
| Japan |
Condition
Condition
Helicobacter pylori infection
Classification by specialty
| Gastroenterology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Helicobacter pylori eradication for junior high school student
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Success rate of helicobacter pylori eradication for junior high school student
Key secondary outcomes
The incidence of side effect through the helicobacter pylori eradication for junior high school student
The change of micro biome before and after the eradication therapy in children
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Eradication therapy for Helicobacter pylori
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
| 12 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Helicobacter pyroli infection
Key exclusion criteria
Students or their parents refuse the eradication therapy.
Student who have an allergy to medicine.
Student who is less than 40 kg in weght.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chika Kusano |
Organization
Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine
Division name
Gastroenterology & Hepatology
Zip code
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL
03-3293-1711
ckusano2007@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chika Kusano |
Organization
Department of Medicine, Nihon University School of Medicine
Division name
Gastroenterology & Hepatology
Zip code
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL
03-3293-1711
Homepage URL
ckusano2007@yahoo.co.jp
Sponsor or person
Institute
Yurihonjyo and Nikaho city
Institute
Department
Personal name
Funding Source
Organization
Yurihonjyo and Nikaho city
Organization
Division
Category of Funding Organization
Local Government
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
JA秋田厚生連由利組合総合病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 03 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 13 | Day |
Last modified on
| 2019 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020737
