UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038349 |
|---|---|
| Receipt number | R000043704 |
| Scientific Title | A study on the effects of different eating habits on intestinal flora. |
| Date of disclosure of the study information | 2019/10/23 |
| Last modified on | 2020/01/24 12:32:49 |
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Basic information
Public title
A study on the effects of different eating habits on intestinal flora.
Acronym
A study on the effects of different eating habits on intestinal flora.
Scientific Title
A study on the effects of different eating habits on intestinal flora.
Scientific Title:Acronym
A study on the effects of different eating habits on intestinal flora.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Two groups of subjects living in an urban area and a rural area (Okishima-Cho, Omihachiman-Shi, Shiga) participated in this study. Our goals are to observe the effects of their different eating habits on their health condition and intestinal flora and compare the differences between two groups.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood and stool tests
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.40 to 89 years old.
2.Regardless of sex.
3.Those who live in Okishima-Cho, Omihachiman-Shi, Shiga and who have tasted funazushi, the extremely fermented crucian carp.
4.Those who understand the main purpose of the study and who can provide their informed consent.
Key exclusion criteria
1.Those who received gastrointestinal surgery (except appendectomy).
2.Those who have a current or a past medical history of severe disease.
3.Those who received Helicobacter pylori eradication treatment during the last 6 months.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
imeQ RD inc.
Division name
Sales department
Zip code
169-0051
Address
2-14-6, Nishi-Waseda, Shinjyuku, Tokyo, Japan
TEL
03-6205-6222
h-kayama@imeqrd.co.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Yuzawa |
Organization
imeQ RD inc.
Division name
Sales department
Zip code
169-0051
Address
2-14-6, Nishi-Waseda, Shinjyuku, Tokyo, Japan
TEL
03-6205-6222
Homepage URL
n-yuzawa@imeqrd.co.jp
Sponsor or person
Institute
integrate co., ltd.
imeQ RD inc.
Institute
Department
Personal name
Funding Source
Organization
Nippon Suisan Kaisha,Ltd.
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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6205-6222
suda-clinic_irb@imeq.co.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 | 10 | Month | 23 | 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
12
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
| 2019 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The subjects living in a rural area (Okishima-Cho, Omihachiman-Shi, Shiga) participated in this study.
We observed their health condition and intestinal flora.
Management information
Registered date
| 2019 | Year | 10 | Month | 21 | Day |
Last modified on
| 2020 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043704
| 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 |
