UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039727 |
|---|---|
| Receipt number | R000045244 |
| Scientific Title | Test for construction of human fecal metabolome analytical method |
| Date of disclosure of the study information | 2020/03/09 |
| Last modified on | 2020/03/06 16:33:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Test for construction of human fecal metabolome analytical method
Acronym
Construction of human fecal metabolome analytical method
Scientific Title
Test for construction of human fecal metabolome analytical method
Scientific Title:Acronym
Construction of human fecal metabolome analytical method
Region
| Japan |
Condition
Condition
Not applicable (Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To construct the dietary intake method for analyzing fecal metabolome in the study of cross-talk between intestinal microbiome and host
Basic objectives2
Others
Basic objectives -Others
Development of a novel method
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Alterlation of fecal metabolome by the consumption of test meal (strict diet control for 1 and 4 days)
Key secondary outcomes
Alterlation of fecal microbiota (16S rRNA gene amplicon sequencing) by the consumption of test meal (strict diet control for 1 and 4 days)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Three identical meals a day, which are supervised by a nutritionist, are served on a fixed schedule (one day test and 4 days test). Participants do not take any foods except identical meals and water.
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
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
The participants who provided informed consent
Key exclusion criteria
1. Participants who have allergy of food stuffs used in the identical meals
2. Participants who have serious constpation and diarrhea
3. Participants who enrolled in other trails within 3 month, or are currently participating in other trials
4. Participants who complain any malfunction during test
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Mitsuharu |
| Middle name | |
| Last name | Matsumoto |
Organization
Kyodo Milk Industry Co. Ltd.
Division name
Research Laboratories
Zip code
190-0182
Address
20-1 Hirai, Hinode-machi, Nishitama-gun, Tokyo 190-0182
TEL
042-597-5911
m-matumoto@meito.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
TEL
03-6205-6222
Homepage URL
n-yuzawa@imeqrd.co.jp
Sponsor or person
Institute
Kyodo Milk Industry Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kyodo Milk Industry 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
Iryouhoujinsyadan Hakusuikai, Suda Clinic institutional review board
Address
2-8-14, Takadanobaba, Shinjyuku, Tokyo, Japan
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
協同乳業株式会社研究所（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 06 | Day |
Last modified on
| 2020 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045244
