UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037318 |
|---|---|
| Receipt number | R000042547 |
| Scientific Title | Observational study on microbiota and constipation in diabetic patients |
| Date of disclosure of the study information | 2019/07/09 |
| Last modified on | 2024/01/12 13:04:10 |
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Basic information
Public title
Observational study on microbiota and constipation in diabetic patients
Acronym
Observational study on microbiota and constipation in diabetic patients
Scientific Title
Observational study on microbiota and constipation in diabetic patients
Scientific Title:Acronym
Observational study on microbiota and constipation in diabetic patients
Region
| Japan |
Condition
Condition
diabetes
Constipation
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between the presence of constipation and the microbiota in diabetic patients.
Basic objectives2
Others
Basic objectives -Others
It has been often reported that diabetes are related with microbiota. Moreover, it has been reported that the frequency of constipation is high in diabetic patients. Therefore, we examine the relationship between the presence of constipation and microbiota in diabetic patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between microbiota and the presence of constipation
Key secondary outcomes
Relationship between microbiota and the HbA1c, serum C-peptide immunoreactivity, urinary albumin
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
Diabetes patient who visit the Saiseikai Yokohamashi Nanbu Hospital
Key exclusion criteria
dementia
mental illness such as depression
malignant tumor of digestive tract
inappropriate case of physician judgement
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Osada |
| Middle name | |
| Last name | Uru |
Organization
Saiseikai Yokohamashi Nanbu Hospital
Division name
diabetes and endocrinology
Zip code
2348503
Address
3 Chome-2-10 Konandai, Konan ward, Yokohama city, Kanagawa prefecture
TEL
0458321111
amadeus@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yamada |
| Middle name | |
| Last name | Taku |
Organization
Saiseikai Yokohamashi Nanbu Hospital
Division name
diabetes and endocrinology
Zip code
2348503
Address
3 Chome-2-10 Konandai, Konan ward, Yokohama city, Kanagawa prefecture
TEL
0458321111
Homepage URL
taku.y.0215@gmail.com
Sponsor or person
Institute
Saiseikai Yokohamashi Nanbu Hospital
Institute
Department
Personal name
Funding Source
Organization
Takanashi milk products Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Yokohamashi Nanbu Hospital
Address
3 Chome-2-10 Konandai, Konan ward, Yokohama city, Kanagawa prefecture
Tel
0458321111
soumu01@nanbu.saiseikai.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
| 2019 | Year | 07 | Month | 09 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observe microbiota and constipation
Management information
Registered date
| 2019 | Year | 07 | Month | 09 | Day |
Last modified on
| 2024 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042547
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/04/22 | 山田研究計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
