UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040382 |
|---|---|
| Receipt number | R000046082 |
| Scientific Title | Observational study on microbiota for onset of digestive disorders |
| Date of disclosure of the study information | 2020/05/12 |
| Last modified on | 2020/05/12 20:16:12 |
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Basic information
Public title
Observational study on microbiota for onset of digestive disorders
Acronym
Observational study on microbiota for onset of digestive disorders
Scientific Title
Observational study on microbiota for onset of digestive disorders
Scientific Title:Acronym
Observational study on microbiota for onset of digestive disorders
Region
| Japan |
Condition
Condition
digestive disorders
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between the presence of digestive disorders and the microbiota in patients.
Basic objectives2
Others
Basic objectives -Others
It has been often reported that digestive disorders are related with microbiota. Therefore, we examine the relationship between the presence of digestive disorders and microbiota in patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between microbiota and the digestive disorders
Key secondary outcomes
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
digestive disorder
Key exclusion criteria
Active intestinal tuberculosis, Infectious enteritis
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Suzuki |
Organization
Fujisawa Shounandai Hospital
Division name
department of surgery
Zip code
252-0802
Address
2345 Takakura, Fujisawa, Kanagawa
TEL
0466-44-1451
shinsuke_suzuki@fj-shounandai.or.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Suzuki |
Organization
Fujisawa Shounandai Hospital
Division name
department of surgery
Zip code
252-0802
Address
2345 Takakura, Fujisawa, Kanagawa
TEL
0466-44-1451
Homepage URL
shinsuke_suzuki@fj-shounandai.or.jp
Sponsor or person
Institute
Fujisawa Shounandai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujisawa shounandai hospital
Address
2345 Takakura, Fujisawa, Kanagawa
Tel
0466-44-1451
t_ohata@fj-shounandai.or.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
| 2020 | Year | 05 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation the relationship of microbiota and digestive disorders
Management information
Registered date
| 2020 | Year | 05 | Month | 12 | Day |
Last modified on
| 2020 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046082
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
