UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022209 |
|---|---|
| Receipt number | R000025583 |
| Scientific Title | Microbiota analysis in chronic gastroenterological diseases. |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2016/05/05 15:56:38 |
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Basic information
Public title
Microbiota analysis in chronic gastroenterological diseases.
Acronym
Microbiota in chronic gastroenterological disease
Scientific Title
Microbiota analysis in chronic gastroenterological diseases.
Scientific Title:Acronym
Microbiota in chronic gastroenterological disease
Region
| Japan |
Condition
Condition
Chronic gastroenterological disease and hepato-biliary-pancreatic diseases
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal the effect of microbiota changes in chronic gastroenterological and hepato-biliary pancreatic diseases.
There are more than 100 species of intestinal microbiota in the gut. These microbiota resident in the intestine and affect human immune system or gastrointestinal diseases progression. Recently, a high-throughput culture-independent pyrosequencing method has enabled us to find the disease specific microbiota changes. As we are interested in the microbiota and the microbiota produced metabolites, we analyze the gut and the oral cavity mircrobiome and metabolome analysis in chronic gastroenterological diseases and hepato-biliary pancreatic diseases.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Microbiome and Metabolome analysis for disease condition:
The gut and the oral cavity microbiome analysis and metabolome analysis will be performed. The correlation between disease condtion and the specific microbiota and/or metabolite will be analyzed.
Key secondary outcomes
Microbiome and Metabolome anaysis for laboratory data:
Age,
Liver related data;AST,ALT,gGTP,Alb,Total bilirubin
Diabetes related data;FPG,IRI,HbA1c
Tumor markers;CEA,CA125,CA19-9,SCC,CK19
Autoantibodies;ANA,IgG
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
Chronic gastroenterological and hepato-biliary-pancreatic disease patients who met following criteria and obtained written informed consent.
1)Chronic gastroenterological and hepato-biliary-pancreatic disease patients (Chronic inflammatory disease 110, Cancer patients110)
2) 20 years of age or more.
Key exclusion criteria
Key exclusion criteria;
1) Patients who decided not suitable by the physicians.
2) Age less than 20 and patients who can not undestand the protocol.
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akinobu Takaki |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharamaceutical Sciences
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-5-1 Shikata Cho, Kita-Ku, Okayama City
TEL
+81-86-235-7219
akitaka@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akinobu Takaki |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharamaceutical Sciences
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-5-1 Shikata Cho, Kita-Ku, Okayama City
TEL
+81-86-235-7219
Homepage URL
akitaka@md.okayama-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology
Okayama University Graduate School of Medicine, Dentistry, and Pharamaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology
Okayama University Graduate School of Medicine, Dentistry, and Pharamaceutical Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
岡山大学病院、倉敷中央病院、岡山赤十字病院、岡山済生会総合病院、香川県立中央病院、福山医療センター
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | 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
Date of protocol fixation
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
We define the microbiome and metabolome analysis in the patients concerning the clinical characteristics. The 3 years clinical outcome is also included in the analysis.
Management information
Registered date
| 2016 | Year | 05 | Month | 05 | Day |
Last modified on
| 2016 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025583
| 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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