UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044405 |
|---|---|
| Receipt number | R000050726 |
| Scientific Title | Examination of changes in gut microbiota and host parameters before and after intake of food X |
| Date of disclosure of the study information | 2021/06/02 |
| Last modified on | 2021/12/01 09:25:33 |
* 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
Measurement of microbiota and its metabolite in stool and blood before and after intake of food X
Acronym
Measurement of microbiota and its metabolite in stool and blood before and after intake of food X
Scientific Title
Examination of changes in gut microbiota and host parameters before and after intake of food X
Scientific Title:Acronym
Examination of changes in gut microbiota and host parameters before and after intake of food X
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate changes in microbiota and concentrations of bacteria-derived metabolites in stool and blood caused by food X, and to elucidate the relationship between individual differences in these changes and intestinal bacterial species Y attached to food X
Basic objectives2
Others
Basic objectives -Others
To verify the effect of intestinal bacterial species Y attached to food X on individual differences in the response of intestinal microbiota to the ingestion of food X
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of "changes in fecal microbiota and short-chain fatty acids between the intake and non-intake periods of food X" and "presence of endogenous intestinal bacterial species Y"
Key secondary outcomes
Correlation of "changes in blood and fecal metabolites between the intake and non-intake periods of food X" and "presence of endogenous intestinal bacterial species Y"
Amount of food X discharged in stool and bacterial attachment status
Bowel habit
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
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
After a 2-week period of no Food X intake, subjects will take 18 g of Food X per day (6 g, 3 times) for 2 weeks, followed by another 2 weeks of no Food X intake.
During the above period, the subjects eat and drink as usual, and avoid consuming Food X and foods containing similar ingredients.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults who have a bowel movement almost every day
Key exclusion criteria
Adults who are unable to consume the test meal due to allergies or other reasons
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Oishi |
Organization
Yakult Central Institute
Division name
Basic Research Department
Zip code
186-8650
Address
Izumi 5-11, Kunitachi, Tokyo, Japan
TEL
042-577-8960
kenji-ooishi@yakult.co.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Nagara |
Organization
Yakult Central Institute
Division name
Basic Research Department
Zip code
186-8650
Address
Izumi 5-11, Kunitachi, Tokyo, Japan
TEL
042-577-8960
Homepage URL
yusuke-nagara@yakult.co.jp
Sponsor or person
Institute
Basic Research department, Yakult Central Institute
Institute
Department
Personal name
Funding Source
Organization
Yakult Central Institute
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.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
| 2021 | Year | 06 | Month | 02 | 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
| 2020 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 02 | Day |
Last modified on
| 2021 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050726
