UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044959 |
|---|---|
| Receipt number | R000051370 |
| Scientific Title | The observational study of the association between gut microbiota, body mass indices and obesity-related complications. |
| Date of disclosure of the study information | 2021/07/26 |
| Last modified on | 2025/01/27 19:20:07 |
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Basic information
Public title
The study of the association between gut microbiota, body mass indices and obesity-related complications.
Acronym
The study of microbiota and body mass indices.
Scientific Title
The observational study of the association between gut microbiota, body mass indices and obesity-related complications.
Scientific Title:Acronym
The observational study of the association between gut microbiota and body mass indices.
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the association between body mass indices, obesity-related complications and the function of intestinal bacteria such as the ability to produce EPS in patients with obesity.
Basic objectives2
Others
Basic objectives -Others
The examination of the function of gut microbiota.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between the amount of EPS-producing bacteria and BMI.
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
The patients with BMI of 25 or more who are outpatients or hospitalized in the Division of Endocrinology Metabolism and Nephrology, Keio University Hospital, and who have given written informed consent to this study.
Key exclusion criteria
1) Patients taking medications which have effects on intestinal bacteria, such as antibacterial agents or proton pump inhibitors.
2) Patients being treated for gastrointestinal disorders.
3) Patients with a history of gastrointestinal surgery other than appendectomy.
4) Patients who are pregnant or may become pregnant.
5) Patients with difficult-to-manage mental illness.
6) Patients who cannot give written informed consent or do not understand the outline and purpose of the study.
7) Patients who are decided to be inappropriate for conducting this study by the principal investigator or the investigators.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Junichiro |
| Middle name | |
| Last name | Irie |
Organization
Keio University School of Medicine
Division name
Division of Endocrinology, Metabolism, and Nephrology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-5363-3797
j-irie@z8.keio.jp
Public contact
Name of contact person
| 1st name | Junichiro |
| Middle name | |
| Last name | Irie |
Organization
Keio University School of Medicine
Division name
Division of Endocrinology, Metabolism, and Nephrology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-5363-3797
Homepage URL
j-irie@z8.keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
The Ethics Committee in Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku, Tokyo
Tel
03-3353-1211
https://www.ctr.med.keio.ac.jp/forms/
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
| 2021 | Year | 07 | Month | 26 | 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 | 04 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of the study is to examine the association between body mass indices, obesity-related complications and the function of intestinal bacteria such as the ability to produce EPS in patients with obesity.
Management information
Registered date
| 2021 | Year | 07 | Month | 26 | Day |
Last modified on
| 2025 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051370
