UMIN-CTR Clinical Trial

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