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

Email



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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name