UMIN-CTR Clinical Trial

Basic information
Public title	clinical efficacy of oral administration of metronidazole in the treatment of primary sclerosing cholangitis
Acronym	clinical efficacy of oral administration of metronidazole in the treatment of PSC
Scientific Title	clinical efficacy of oral administration of metronidazole in the treatment of primary sclerosing cholangitis
Scientific Title:Acronym	clinical efficacy of oral administration of metronidazole in the treatment of PSC
Region	Japan

Condition
Condition	primary sclerosing cholangitis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aim to evaluate the efficacy and the safety of oral administration of metronidazole for 12 weeks during the administration period and subsequent 12 weeks following the cessation. Furthermore, We examine the interaction of gut microbiota and immune cells during the treatment, aiming to clarify the pathogenesis of PSC via gut-liver axis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Serological improvement in the hepatobiliary function (serum ALP and total bilirubin) at 12weeks after the treatment
Key secondary outcomes	Alteration of the intestinal flora during the treatment

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	Patients take metronidazole 250mg orally three times day for 3 weeks.
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients with a chronic cholestasis who are diagnosed as PSC with the specific findings by MRCP or ERCP 2. Patients with chronic liver injury or compensated liver cirrhosis (Child Pugh score below 9 point) 3. Presence or absence of the PSC-related colitis does not matter for an entry 4. Patients elder than 16 years old who are consented in writing of the applicant
Key exclusion criteria	Patients with a decompensated cirrhosis (Child Pugh score upper 10 point)
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Nobuhiro Nakamoto
Organization	Keio University, School of Medicine
Division name	Division of Gastroenterology and Hepatology
Zip code
Address	35 Shinanomachi Shinjuku-ku, Tokyo
TEL	+81-3-3353-1211
Email	nobuhiro@z2.keio.jp

Public contact
Name of contact person	1st name Middle name Last name Nobuhiro Nakamoto
Organization	Keio University, School of Medicine
Division name	Division of Gastroenterology and Hepatology
Zip code
Address	35 Shinanomachi Shinjuku-ku, Tokyo
TEL	+81-3-3353-1211
Homepage URL
Email	nobuhiro@z2.keio.jp

Sponsor
Institute	Keio University, School of Medicine
Institute
Department

Funding Source
Organization	Keio University, School of Medicine
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	2016 Year 04 Month 01 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	Completed
Date of protocol fixation	2016 Year 01 Month 01 Day
Date of IRB	2016 Year 02 Month 22 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 03 Month 09 Day
Last modified on	2019 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024696