UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044405
Receipt No. 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 2021/06/02

* 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
Email 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
Email yusuke-nagara@yakult.co.jp

Sponsor
Institute Basic Research department, Yakult Central Institute
Institute
Department

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
Email 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
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 08 Month 21 Day
Date of IRB
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 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050726

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.