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
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
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
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
