UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054817 |
|---|---|
| Receipt number | R000062636 |
| Scientific Title | Survey of bacterial flora in healthy subjects |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2024/06/28 23:22:53 |
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Basic information
Public title
Survey of bacterial flora in healthy subjects
Acronym
Survey of bacterial flora in healthy subjects
Scientific Title
Survey of bacterial flora in healthy subjects
Scientific Title:Acronym
Survey of bacterial flora in healthy subjects
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Numerous intestinal microbiota coexist in the intestines of animals, including humans. The human large intestine has a bacterial concentration of 10 billion to 1 trillion per gram of content, with the total number said to be as high as 100 trillion. It has become clear that the intestinal flora is closely related to the human physiological state and is essential for maintaining the human body. In recent years, there have been increasing reports on the intervention of prebiotics (oligosaccharides, dietary fiber, etc.) and probiotics (so-called intestinal regulators) regarding the relationship between disease and disturbance of intestinal microflora.
In this study, we will comprehensively analyze the fecal, saliva, and skin-bacterial flora of healthy subjects to create a database that will serve as a comparison standard for each study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of bacterial flora
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. People who have received a sufficient explanation, fully understood the study, and freely given written informed consent to participate in this study.
2. Healthy subjects aged 18 or older at the time of consent
3. People with no underlying diseases and no history of regular medical people
4. People who haven't taken antibiotics within one week of the sampling date
Key exclusion criteria
1. People who have underlying diseases and are receiving medical treatment
2. People who have taken antibiotics
3. People who are judged to be inappropriate by a doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Hirooka |
Organization
Fujita health University
Division name
Department of Gastroenterology and Hepatology
Zip code
470-1192
Address
1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi
TEL
0562932324
yoshiki.hirooka@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Funasaka |
Organization
Fujita Health University
Division name
Department of Gastroenterology and Hepatology
Zip code
470-1192
Address
1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi
TEL
0562932324
Homepage URL
k-funa@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita health 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
Fujita Health University
Address
1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi
Tel
0562932865
f-irb@fujita-hu.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
| 2024 | Year | 07 | Month | 01 | 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
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analysis of bacterial flora in feces, saliva, and skin surface of healthy subjects
Management information
Registered date
| 2024 | Year | 06 | Month | 28 | Day |
Last modified on
| 2024 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062636
