UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020917 |
|---|---|
| Receipt number | R000024135 |
| Scientific Title | The enteral environment analysis using the human feces for the chronic liver disease and relative examination with the clinical data, multiple center study. |
| Date of disclosure of the study information | 2016/02/07 |
| Last modified on | 2020/09/21 15:58:14 |
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Basic information
Public title
The enteral environment analysis using the human feces for the chronic liver disease and relative examination with the clinical data, multiple center study.
Acronym
Chronic liver disease and enterobacteria
Scientific Title
The enteral environment analysis using the human feces for the chronic liver disease and relative examination with the clinical data, multiple center study.
Scientific Title:Acronym
Chronic liver disease and enterobacteria
Region
| Japan |
Condition
Condition
Chronic liver disease (nonalcoholic steatohepatitis, nonalcoholic fatty liver disease), healthy volunteer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It has known the relationship of between chronic liver disease and enterobacteria. But, it remains unclear. In this study, we aimed to clarify the relation of the pathogenesis that we analyzed intestinal bacteria according to each disease of the chronic liver disease and compared it with clinical data.
Basic objectives2
Others
Basic objectives -Others
The identification of fecal bacteria, which significantly defferene in each chronic liver disease compared with healthy volunteer
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Difference of bacterial flora between healthy volunteer and each chronic liver disease.
Key secondary outcomes
Difference of parameters as below between healthy volunteer and each chronic liver disease.
Blood: endotoxin, metabolome(bile acid, organic acid, short chain fatty acid, amino acid etc.).
Feces: metabolome (bile acid, organic acid, short chain fatty acid, amino acid etc.), mucin
Urine: lactulose mannnitol ratio.
Comparison of the above items with clinical findings.
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
The patients who are diagnosed as follows: Chronic hepatitis patients, especially, NASH/NAFLD patients who are diagnosed based on the Medical treatment guide 2010 of NASH, NAFLD of Japanese liver society guidelines and healthy volunteer.
Key exclusion criteria
1) Re-registration example to the examination
2) The patients with malignant tumor
3) In addition, the patient who judged an arrangement to the examination if the medical attendant was inappropriate
4) The patients that specimen collection is not possible by dyschezia.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Takaomi |
| Middle name | |
| Last name | Kessoku |
Organization
Yokohama city university
Division name
Gastroentelorogy and hepatology
Zip code
236-0004
Address
3-9, Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2640
Kessoku-tho@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kento |
| Middle name | |
| Last name | Imajo |
Organization
Yokohama city university
Division name
Gastroentelorogy and hepatology
Zip code
236-0004
Address
3-9, Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2640
Homepage URL
kento318@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama city university gastroenterology and hepatorogy
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Saga university
JA hiroshima hospital
Kawasaki medical university
Kurume university
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama city university
Address
3-9, Fukuura, Kanazawa-ku, Yokohama city, Kanagawa
Tel
045-787-2640
kessoku-tho@umin.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
横浜市立大学(神奈川県)、佐賀大学（佐賀県）、JA広島総合病院（広島県）、川崎医科大学（岡山県）、久留米大学（福岡県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
study design: Cross sectional study
Recruitment of target people:the patients who are diagnosed as follows: Chronic hepatitis patients, especially, NASH/NAFLD patients who are diagnosed based on the Medical treatment guide 2010 of NASH, NAFLD of Japanese liver society guidelines and healthy volunteer.
Item to measure: fecal microbiota, fecal metabolome (bile acid, organic acid, short chain fatty acid, amino acid), fecal mucin, peripheral blood endotoxin, urine lactulose mannitol ratio.
Management information
Registered date
| 2016 | Year | 02 | Month | 07 | Day |
Last modified on
| 2020 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024135
| Research Plan | |
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| 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 |
