UMIN-CTR Clinical Trial

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
Email	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
Email	n-yuzawa@imeqrd.co.jp

Sponsor
Institute	Kyodo Milk Industry Co. Ltd.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045244