UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039148 |
|---|---|
| Receipt number | R000044649 |
| Scientific Title | Identification of new biomarkers for intestinal barrier function |
| Date of disclosure of the study information | 2020/01/19 |
| Last modified on | 2021/07/19 10:38:23 |
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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
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
masashi.morifuji@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044649
