UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048918 |
|---|---|
| Receipt number | R000055739 |
| Scientific Title | An exploratory clinical study on relations between gut microbiota and osteoporosis |
| Date of disclosure of the study information | 2022/09/12 |
| Last modified on | 2023/07/01 00:53:48 |
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Basic information
Public title
An exploratory clinical study on relations between gut microbiota and osteoporosis
Acronym
An exploratory clinical study on relations between gut microbiota and osteoporosis
Scientific Title
An exploratory clinical study on relations between gut microbiota and osteoporosis
Scientific Title:Acronym
An exploratory clinical study on relations between gut microbiota and osteoporosis
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the gut microbiota genes and blood metabolites in osteoporosis patients and healthy individuals
Basic objectives2
Others
Basic objectives -Others
To identify the microbiota genes and blood metabolites of osteoporosis
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Differences in the gut microbiota genes and blood metabolites in osteoporosis patients and healthy individuals
Key secondary outcomes
1.Relationship between gut microbiota genes and gut microbiota
2.Relationship between gut microbiota genes and blood metabolites and bone metabolism markers and bone density
3.Relationship between analysis results of intestinal flora and blood metabolites, patient background information, and dietary questionnaire results
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
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
Postmenopausal women aged 65 older diagnosed with osteoporosis or normal, who understand the purpose of this research and obtain written consent
Key exclusion criteria
1.Subjects taking steroids, antibiotics, proton pump inhibitors (Nexium, Takepron, Omeprazole, etc.)
2.Subjects with idiopathic osteoporosis, femoral neck fracture, bone tumor, rheumatoid arthritis, diabetes, chronic kidney disease
3.Subjects who have difficulty collecting specimens
4.Subjects judged by the principal investigator to be unsuitable as research subjects
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasuteru |
| Middle name | |
| Last name | Kodama |
Organization
Ohara Clinic
Division name
Ohara Clinic
Zip code
156-0041
Address
Ohara 2-23-19, Setagaya, Tokyo
TEL
03-3324-3077
official@ohara-clinic.net
Public contact
Name of contact person
| 1st name | Yasuteru |
| Middle name | |
| Last name | Kodama |
Organization
Ohara Clinic
Division name
Ohara Clinic
Zip code
156-0041
Address
Ohara 2-23-19, Setagaya, Tokyo
TEL
03-3324-3077
Homepage URL
official@ohara-clinic.net
Sponsor or person
Institute
Ohara Clinic
Institute
Department
Personal name
Funding Source
Organization
Asahi Kasei Corporation
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
Ethics Committees of NISHI-UMEDA Clinic for Asian Medical Collaboration
Address
3F Maruito Nishiumeda Build. 3-3-45 Umeda, Kita-ku, Osaka
Tel
06-4797-5660
jimukyoku@amc-clinc.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 | 09 | 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
30
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
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
Study subject: Osteoporosis patients or healthy subjects
Study period: March, 2022-February, 2023
Recruitment period: March, 2022-September, 2022
Management information
Registered date
| 2022 | Year | 09 | Month | 12 | Day |
Last modified on
| 2023 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055739
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
