UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020917
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kento318@yokohama-cu.ac.jp

Sponsor
Institute Yokohama city university gastroenterology and hepatorogy
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024135

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.