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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012814
Receipt No. R000014955
Scientific Title Safety and efficacy of fecal microbiota transplantation in intractable bowel diseases
Date of disclosure of the study information 2014/01/10
Last modified on 2019/07/17

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Basic information
Public title Safety and efficacy of fecal microbiota transplantation in intractable bowel diseases
Acronym Fecal microbiota transplantation in bowel diseases
Scientific Title Safety and efficacy of fecal microbiota transplantation in intractable bowel diseases
Scientific Title:Acronym Fecal microbiota transplantation in bowel diseases
Region
Japan

Condition
Condition Ulcerative colitis, Intestinal Behcet, Clostridium difficile infection
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of fecal microbiota transplantation in intractable bowel disease patients
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety
Efficacy
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 Administration of feces obtained from healthy donors to patients.
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Ulcerative colitis patients with moderate to severe activity despite treatment with corcicosteroids, anti-TNFa Ab, tacrolimus or immunomodulators.
2. Patients with intestinal Behcet's disease who have ulcers in the intestine despite treatment with corcicosteroids or anti-TNFa Ab.
3. Patients with C. difficile infection who have gastrointestinal symptoms despite administration of vancomycin or metronidazole.
4. Donors should be patient's spouse or first- or second-degree relatives.
Key exclusion criteria 1. Donors who show abnormal findings to the screening tests including blood and feces.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Takanori
Middle name
Last name Kanai
Organization Department of Internal Medicine, Keio University School of Medicine
Division name Division of Gastroenterology and Hepatology
Zip code 1608582
Address 35 Shinano-machi, Shinjuku Tokyo
TEL 03-3353-1211
Email takagast@z2.keio.jp

Public contact
Name of contact person
1st name Kosaku
Middle name
Last name Nanki
Organization Department of Internal Medicine, Keio University School of Medicine
Division name Division of Gastroenterology and Hepatology
Zip code 1608582
Address 35 Shinano-machi, Shinjuku Tokyo
TEL 03-3353-1211
Homepage URL
Email kosakun214@hotmail.com

Sponsor
Institute Division of Gastroenterology and Hepatology,Department of Internal Medicine, Keio University School of Medicine
Institute
Department

Funding Source
Organization Division of Gastroenterology and Hepatology,Department of Internal Medicine, 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 Keio University School of Medicine
Address 35, Shinanomachi, Shinjuku, Tokyo
Tel 0333531211
Email kosakun214@hotmail.com

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
2014 Year 01 Month 10 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 Open public recruiting
Date of protocol fixation
2013 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 14 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
2014 Year 01 Month 10 Day
Last modified on
2019 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014955

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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