UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022143
Receipt number R000025150
Scientific Title Multicenter prospective study on the microbiome and the clinical condition of primary sclerosing cholangitis (PSC) with using the human feces.
Date of disclosure of the study information 2016/04/29
Last modified on 2019/10/14 16:21:35

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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 or person

Institute

Department of Gastroenterology and Hepatology
Yokohama City University School of medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025150


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name