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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000017105
Receipt No. R000019843
Scientific Title Safety of Helicobacter pylori eradication therapy in patients with inflammatory bowel disease
Date of disclosure of the study information 2015/04/13
Last modified on 2015/04/11

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Basic information
Public title Safety of Helicobacter pylori eradication therapy in patients with inflammatory bowel disease
Acronym Relationship of inflammatory bowel disease and Helicobacter pylori infection
Scientific Title Safety of Helicobacter pylori eradication therapy in patients with inflammatory bowel disease
Scientific Title:Acronym Relationship of inflammatory bowel disease and Helicobacter pylori infection
Region
Japan

Condition
Condition Inflammatory bowel disease (Ulcerative colitis, Crohn's disease)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy and safety of Helicobacter pylori eradication therapy in patients with inflammatory bowel disease (IBD).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Influence of Helicobacter pylori eradication therapy for IBD disease activity.
Key secondary outcomes Specifications of Helicobacter pylori infection in patients with IBD.

Base
Study type

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
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 IBD patients with Helicobacter pylori infection.
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 The patients with IBD under remission stage (Ulcerative colitis: partial mayo score<3, Crohn's disease: CDAI<150)
Key exclusion criteria 1) The patient who is not infected by Helicobacter pylori
2) The patient who is not under remission stage of IBD
3) The patient who is required the change of treatment for IBD during observation period
4) The patient who has allergy for penicillin
5) The patient who has malignant disease
6) The patient who has been already eradicated Helicobacter pylori
7) The patient who dose not agree with this study
8) The patinets who are determiend not to be appropriate for this study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhide Higuchi
Organization Osaka medical collage
Division name Second department of internal medicine
Zip code
Address 2-7, daigaku-cho, Takatsuki City, Osaka, Japan
TEL 072-683-1221
Email higuchi@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiko Okada
Organization Osaka medical collage
Division name Second department of internal medicine
Zip code
Address 2-7, daigaku-cho, Takatsuki City, Osaka, Japan
TEL 072-683-1221
Homepage URL
Email toshi52omc@yahoo.co.jp

Sponsor
Institute Osaka medical collage
Institute
Department

Funding Source
Organization None
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
Email

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
2015 Year 04 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 01 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 13 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 04 Month 11 Day
Last modified on
2015 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019843

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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