UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018068 |
|---|---|
| Receipt number | R000019551 |
| Scientific Title | A role of gut microbiota in the pathogenesis of gastrointestinal and liver diseases and the clinical application |
| Date of disclosure of the study information | 2015/06/24 |
| Last modified on | 2015/06/24 14:55:20 |
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Basic information
Public title
A role of gut microbiota in the pathogenesis of gastrointestinal and liver diseases and the clinical application
Acronym
A role of gut microbiota in the pathogenesis of gastrointestinal and liver diseases
Scientific Title
A role of gut microbiota in the pathogenesis of gastrointestinal and liver diseases and the clinical application
Scientific Title:Acronym
A role of gut microbiota in the pathogenesis of gastrointestinal and liver diseases
Region
| Japan |
Condition
Condition
1)Nonalcoholic steatohepatitis (NASH)
2)Alcoholic hepatitis (ASH)
3)Liver cirrhosis due to NASH, ASH, viral hepatitis, Autoimmune hepatitis , Primary biliary cirrhosis, and Primary sclerosing cholangitis
4)Hepatocellular carcinoma
5)Ulcerative colitis
6)Crohn's diseases
7)Intestinal Behcet's diseases
8)Chronic nonspecific multiple ulcers of the small intestine
9)Autoimmune pancreatitis
10)Eosinophilic esophagitis and gastritis
11)Functional dyspepsia
12)Irritable bowel diseases
13)Diabetes mellitus
14)Simple obesity
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidate the role of intestinal bacteria in the pathogenesis of gastrointestinal and liver diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A comprehensive analysis of microbiota in feces derived from patients
Key secondary outcomes
A reproducibility of diseases by fecal microbiota transplantation of feces derived from patients to germ free mice
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meets each diagnostic criteria.
Key exclusion criteria
1)Patients seropositive for HIV and/or syphilis
2)Patients treated with antibiotics within 1M
3)Patients under treatment with immunosuppressive therapy and/or chemotherapy
4)Patients in poor general condition
Target sample size
260
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, Department of Internal Medicine
Zip code
Address
35 Shinanomachi Shinjuku-ku, Tokyo
TEL
03-3353-1211
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, Department of Internal Medicine
Zip code
Address
35 Shinanomachi Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
nobuhiro@z2.keio.jp
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine
Institute
Department
Personal name
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
Address
Tel
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
| 2015 | Year | 06 | Month | 24 | 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
| 2014 | Year | 10 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2015 | Year | 06 | Month | 24 | Day |
Last modified on
| 2015 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019551
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
