UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047260 |
|---|---|
| Receipt number | R000053838 |
| Scientific Title | Relationships between digestive disease and gut microbiota |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2022/03/23 11:48:55 |
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Basic information
Public title
Relationships between digestive disease and gut microbiota
Acronym
Relationships between digestive disease and gut microbiota
Scientific Title
Relationships between digestive disease and gut microbiota
Scientific Title:Acronym
Relationships between digestive disease and gut microbiota
Region
| Japan |
Condition
Condition
digestive disease
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to clarify the relationships between digestive disease and gut microbiota by analyzing bacterial flora and metabolites of feces, gastrointestinal mucosa, body fluids and so on.
Moreover, we also conduct comprehensive analyses such as transcriptome and metabolome from tissues of the digestive organ. Through these analyses, we would like to develop new therapeutic interventions.
Basic objectives2
Others
Basic objectives -Others
Biological exploration
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationships between digestive disease and gut microbiota
Key secondary outcomes
1. Evaluation of differences by biopsy and bacterial flora
2. Identification of specific bacteria
3. Assessment of changes in bacterial flora by disease progression
4. Assessment of body fluid composition and properties
5. Assessment of bacterial mRNA by real-time PCR using biopsy tissues
6. Comprehensive evaluation of genome, transcriptome, metabolome, protein, etc.
7. Metabolome analysis of short-chain fatty acids, etc.
8. Relationships between gut microbiota, digestive disease and metabolites of feces
9. Relationships between gut microbiota, digestive disease and rare gas component in exhaled breath
10. Search for effective probiotics/prebiotics by fecal culture and blood immune cell culture
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients obtained written informed consent after fully explanation of this study and their understandings.
2. Patients diagnosed with
Digestive disease(esophageal cancer, gastric cancer, duodenal tumor, small intestine / colon tumor, liver cancer, biliary tract cancer, pancreatic cancer, GERD, gastritis, functional dyspepsia, IBD, chronic hepatitis, cirrhosis, inflammatory disease of biliary and pancreas, etc.)
Key exclusion criteria
1.Women who are pregnant or may be pregnant
2. Patients who have severe organ damage
3. Patients who do not have written consent
4.Unsuitable patients who are judged by doctors registered in this study
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Hirooka |
Organization
Fujita Health University
Division name
Department of Gastroenterology and Hepatology
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi
TEL
+81562932324
yoshiki.hirooka@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Funasaka |
Organization
Fujita Health University
Division name
Department of Gastroenterology and Hepatology
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi
TEL
+81562932324
Homepage URL
k-funa@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University hospital
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
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
Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi
Tel
+81562932865
f-irb@fujita-hu.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 03 | Month | 23 | Day |
Last modified on
| 2022 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053838
| 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 |
