UMIN-CTR Clinical Trial

Basic information
Public title	Identification of new biomarkers for intestinal barrier function
Acronym	Identification of new biomarkers for intestinal barrier function
Scientific Title	Identification of new biomarkers for intestinal barrier function
Scientific Title:Acronym	Identification of new biomarkers for intestinal barrier function
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Identification of new biomarkers for intestinal barrier function
Basic objectives2	Others
Basic objectives -Others	Identification of new biomarkers
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To investigate the relationship between known biomarkers for intestinal barrier function and new biomarkers, such as novel compounds and intestinal microflora in biological samples, and to identify new biomarkers for intestinal barrier function.
Key secondary outcomes	To investigate the relationship subjects background, such as physical examination, blood parameters, survey, and intestinal barrier function.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Sugar tolerance test: After a single dose of sugar solution (lactulose 10 g, mannitol 5 g, sucrose 20 g), collect urine for 6 hours.
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 and Female
Key inclusion criteria	1. 20<= 60> year-old females and males 2. Subject must read and sign the informed consent form
Key exclusion criteria	1. History of gastrointestinal surgical procedures 2. Presence of galactosemia 3. Presence of diabetes 4. Presence of a allergy to food containing sugar alcohol 5. Subjects who routinely used pharmaceuticals 6. Pregnant women, lactating and possibly pregnant 7. Subjects who had participated in other clinical trials within the past month 8. Determined ineligible by the principal investigator or sub-investigator
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masashi Middle name Last name Morifuji
Organization	Meiji Co., Ltd.
Division name	Food Microbiology Research Laboratories, R&D Division
Zip code	192-0919
Address	1-29-1 Nanakuni, Hachiouji, Tokyo
TEL	042-632-5822
Email	masashi.morifuji@meiji.com

Public contact
Name of contact person	1st name Masashi Middle name Last name Morifuji
Organization	Meiji Co., Ltd.
Division name	Food Microbiology Research Laboratories, R&D Division
Zip code	192-0919
Address	1-29-1 Nanakuni, Hachiouji, Tokyo
TEL	042-632-5822
Homepage URL
Email	masashi.morifuji@meiji.com

Sponsor
Institute	Meiji Co., Ltd.
Institute
Department

Funding Source
Organization	Meiji 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	Meiji Institutional Review Board
Address	1-29-1 Nanakuni, Hachiouji, Tokyo
Tel	042-632-5900
Email	MEIJI.IRB@meiji.com

Secondary IDs
Secondary IDs	YES
Study ID_1	19112901
Org. issuing International ID_1	CPCC Institutional Review Board
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	チヨダパラメディカルケアクリニック（東京都）

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 19 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	112
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	2019 Year 12 Month 02 Day
Date of IRB	2019 Year 11 Month 29 Day
Anticipated trial start date	2020 Year 01 Month 19 Day
Last follow-up date	2021 Year 03 Month 31 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 01 Month 14 Day
Last modified on	2021 Year 07 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044649