UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of azithromycin for the treatment of nonalcoholic steatohepatitis accompanied with Porphyromonas.gingivalis infection in the liver-Randomized controlled trial
Title of the study (Brief title)	The efficacy of azithromycin for the treatment of nonalcoholic steatohepatitis accompanied with Porphyromonas.gingivalis infection in the liver-Randomized controlled trial
Region	Japan

Condition
Condition	nonalcoholic fatty liver disease/nonalcoholic steatohepatitis
Classification by specialty	Hepato-biliary-pancreatic medicine Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To demonstrate the efficacy and safety of azithromycin for the treatment of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis accompanied with Porphyromonas.gingivalis infection in the liver
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	improvement of liver function test
Key secondary outcomes	improvement of histological findings of the liver

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	medical drug
Interventions/Control_2	placebo
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, NAFLD/NASH with P.gingivalis infection in the liver 2, Patients between 20 years old and older than that, and age less than 80 years old. 3, Patients who agreed to participate in this study.
Key exclusion criteria	1, Patients with alcoholic liver diseases. 2,Patients with viral liver diseases, autoimmune hepatitis, and primary biliary cirrhosis. 3, Paitents with pregnancy. 4, Patients who have allergy against ingredients of azithromicin. 5, Patients who have allergy against other macrolides and ketolides. 6, Patients with liver cirrhosis,liver failure including severe liver function test, hepatocellular carcinoma in the liver and other organs. 7, Patients with severe heart diseases. 8, Patients with hereditary fructose intolerance, glucose-galactose malabsorption, and sucrase-isomaltase deficiency. 9, Medical doctors decided the patients inappropriate.
Target sample size	44

Research contact person
Name of lead principal investigator	Kazuaki Chayama
Organization	Hiroshima University Hospital
Division name	Gastroenterology and Metabolism
Address	1-2-3 Kasumi, Minamiku, Hiroshima, 734-8551, Japan
TEL	082-257-5191
Email

Public contact
Name of contact person	Hideyuki Hyogo
Organization	Hiroshima University Hospital
Division name	Gastroenterology and Metabolism
Address
TEL
Homepage URL
Email	hidehyogo@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University Hospital
Institute
Department

Funding Source
Organization	self funding
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	広島大学病院(広島県）

Other administrative information
Date of disclosure of the study information	2012 Year 11 Month 10 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 10 Month 01 Day
Anticipated trial start date	2012 Year 11 Month 10 Day
Last follow-up date	2014 Year 09 Month 30 Day
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 11 Month 05 Day
Last modified on	2019 Year 03 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008950