UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020269 |
|---|---|
| Receipt number | R000023400 |
| Scientific Title | Correlation between digestive disease and gut microbiota |
| Date of disclosure of the study information | 2015/12/18 |
| Last modified on | 2024/06/24 16:51:58 |
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Basic information
Public title
Correlation between digestive disease and gut microbiota
Acronym
Digestive disease and gut microbiota
Scientific Title
Correlation between digestive disease and gut microbiota
Scientific Title:Acronym
Digestive disease and gut microbiota
Region
| Japan |
Condition
Condition
Digestive disease
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate correlation between digestive disease and gut microbiota
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between digestive disease and gut microbiota by next-generation sequencing
Key secondary outcomes
1. Differences in microbiota according to the disease and region.
2.Determination of specific microbiota according to the disease
3. Changes of microbiota according to disease progression.
4.Characterization and composition of body fluid
5.mRNA and miRNA levels of specimen biopsy
6.Metabolome analysis of short-chain fatty acid
7.Correlation between expiratory noble gases in the exhaled air and gut microbiota, digestive disease
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
biopsy (for patient needs gastrointestinal endoscopy)
period:1
time:1
frequency: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
Hospitalized patient and outpatient who receive Hospitalized patient and outpatient who receive gastrointestinal examination in Nagoya University Hospital
Key exclusion criteria
1.Pregnant women
2.Patient with severe chronic renal failure and chronic heart failure
3.Patient who the investigator considers inappropriate for entry into the trial
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Honda |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8550
Address
65, Tsuruma-cho, Showa-ku, Nagoya
TEL
+81-52-744-2169
honda@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Honda |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8550
Address
65, Tsuruma-cho, Showa-ku, Nagoya
TEL
+81-52-744-2169
Homepage URL
honda@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Hospital
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
Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel
052-741-2111
ethics@med.nagoya-u.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
| 2015 | Year | 12 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Ongoing study
Management information
Registered date
| 2015 | Year | 12 | Month | 18 | Day |
Last modified on
| 2024 | 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=R000023400
