UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter prospective study on the microbiome and the clinical condition of primary sclerosing cholangitis (PSC) with using the human feces.
Acronym	Multicenter prospective study on the microbiome and the clinical condition of primary sclerosing cholangitis (PSC) with using the human feces.
Scientific Title	Multicenter prospective study on the microbiome and the clinical condition of primary sclerosing cholangitis (PSC) with using the human feces.
Scientific Title:Acronym	Multicenter prospective study on the microbiome and the clinical condition of primary sclerosing cholangitis (PSC) with using the human feces.
Region	Japan

Condition
Condition	primary sclerosing cholangitis (PSC)
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	In this study, we aimed to assess the relations between clinical condition and the microbiome in the patients with PSC.
Basic objectives2	Others
Basic objectives -Others	We compare PSC patients with healthy volunteers.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Difference of mcrobiome between PSC patients and healthy volunteers.
Key secondary outcomes	gut metabolite, gut mucin, gut permeability.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	85 years-old >
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 or liver biopsy 2) Presence or absence of the PSC-related colitis does not matter for an entry 3) healthy volunteer
Key exclusion criteria	1) In the opinion of the investigator, patient is unsuitable as a study subject.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yuji Middle name Last name Ogawa
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	236-0004
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa
TEL	045-787-2640
Email	ogaway@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Yuji Middle name Last name Ogawa
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	236-0004
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa
TEL	045-787-2640
Homepage URL
Email	ogaway@yokohama-cu.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology Yokohama City University School of medicine
Institute
Department

Funding Source
Organization	Department of Gastroenterology and Hepatology Yokohama City University School of medicine
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University School of medicine
Address	3-9 Fukuura,Kanazawaku
Tel	045-787-2800
Email	ogaway@yokohama-cu.ac.jp

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	帝京大学病院（東京都） 名古屋第二赤十字病院（愛知県） 千葉大学病院（千葉県） 福島医科大学病院（福島県） 九州医療センター（福岡県） 高知大学病院（高知県） 佐賀大学病院（佐賀県） 久留米大学病院（福岡県） 大阪府立母子保健総合医療センター（大阪府）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 29 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	7
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 03 Month 31 Day
Date of IRB	2016 Year 04 Month 11 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2021 Year 09 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	prospective study

Management information
Registered date	2016 Year 04 Month 29 Day
Last modified on	2019 Year 10 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025150