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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036121
Receipt No. R000041150
Scientific Title Safety and efficacy of fecal microbiota transplantation from healthy volunteers for patients with primary sclerosing cholangitis
Date of disclosure of the study information 2019/05/01
Last modified on 2019/03/07

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Basic information
Public title Safety and efficacy of fecal microbiota transplantation from healthy volunteers for patients with primary sclerosing cholangitis
Acronym Fecal microbiota transplantation for patients with primary sclerosing cholangitis
Scientific Title Safety and efficacy of fecal microbiota transplantation from healthy volunteers for patients with primary sclerosing cholangitis
Scientific Title:Acronym Fecal microbiota transplantation for patients with primary sclerosing cholangitis
Region
Japan

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

Objectives
Narrative objectives1 We elucidate the safety and efficacy of fecal microbiota transplantation (FMT) from healthy volunteers for patients with primary sclerosis cholangitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The level of serum ALP at 1, 2, 4, 8, 12, and 24 weeks post FMT
Key secondary outcomes

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
Other
Interventions/Control_1 fecal microbiota transplantation from healthy volunteers
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 30

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
2019 Year 05 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 Preinitiation
Date of protocol fixation
2019 Year 03 Month 08 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 07 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=R000041150

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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