UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008243 |
|---|---|
| Receipt number | R000009064 |
| Scientific Title | Effect of Helicobacter pyroli eradication on patient with non aclcholic fatty liver disease |
| Date of disclosure of the study information | 2012/06/25 |
| Last modified on | 2018/12/30 09:29:20 |
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Basic information
Public title
Effect of Helicobacter pyroli eradication on patient with non aclcholic fatty liver disease
Acronym
HELPER Study2
Scientific Title
Effect of Helicobacter pyroli eradication on patient with non aclcholic fatty liver disease
Scientific Title:Acronym
HELPER Study2
Region
| Japan |
Condition
Condition
non alcoholic fatty liver disease
Helicobacter pylori infection
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of Helicobacter pylori eradication on patients with non alcoholic fatty liver disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Liver dysfunction at pre and post Helicobacter pylori eradication
Key secondary outcomes
Lipid profile and insulin resistance at pre and post Helicobacter pylori eradication
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
Helicobacter pylori eradication (Lansoprazole60mg/day, AMPC1500mg/day,CAM800mg/day for 7 days)
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)Patients with non alcoholic fatty liver disease
2)Patients with gastric or duodenal ulcer scar and helicobacter pylori infection
Key exclusion criteria
1)Patients with another liver disease
2)Patients with previous hepatectomy
3)Patients with intiated or changed anitidiabetic, antidyslipidemic, antiinflammatory drugs or liver supporting therapy
4)Patients with severe infection or trauma
5)Patients with malignancy
6)Patients with gastric or duodenal ulcer in the acute phase
7)Patients druing pregnancy or lactation
8)Patients with severe liver dysfunction or renal insufficiency
9)Patients who received steroid therapy
10)Patients who were allergic to Helicobacter pylori eradication drugs
11)Patients who cann not take written informed consent
12)Patients determined to be inappropriate by phyysician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Hata |
Organization
Chigasaki Municipal Hospital
Division name
Gastroenterology Division
Zip code
Address
5-15-1 Honson Chigasaki Kanagawa Japan
TEL
0467-52-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Uchiyama |
Organization
Chigasaki Municipal Hospital
Division name
Gastroenterology Division
Zip code
Address
5-15-1 Honson Chigasaki Kanagawa Japan
TEL
0467-52-1111
Homepage URL
tuchiyama-ykh@umin.ac.jp
Sponsor or person
Institute
Chigasaki Municipal Hospital
Institute
Department
Personal name
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
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
| 2012 | Year | 06 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | 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
| 2012 | Year | 06 | Month | 25 | Day |
Last modified on
| 2018 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009064
