UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Helicobacter pyroli eradication on patient with non aclcholic fatty liver disease
Title of the study (Brief title)	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	Yasuo Hata
Organization	Chigasaki Municipal Hospital
Division name	Gastroenterology Division
Address	5-15-1 Honson Chigasaki Kanagawa Japan
TEL	0467-52-1111
Email

Public contact
Name of contact person	Takashi Uchiyama
Organization	Chigasaki Municipal Hospital
Division name	Gastroenterology Division
Address	5-15-1 Honson Chigasaki Kanagawa Japan
TEL	0467-52-1111
Homepage URL
Email	tuchiyama-ykh@umin.ac.jp

Sponsor
Institute	Chigasaki Municipal Hospital
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 03 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009064