UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047085 |
|---|---|
| Receipt number | R000053702 |
| Scientific Title | Test to evaluate the relationship between intestinal barrier function and intestinal environment in healthy subjects |
| Date of disclosure of the study information | 2022/03/07 |
| Last modified on | 2023/04/05 10:32:24 |
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Basic information
Public title
Test to evaluate the relationship between intestinal barrier function and intestinal environment in healthy subjects
Acronym
Test to evaluate the relationship between intestinal barrier function and intestinal environment in healthy subjects
Scientific Title
Test to evaluate the relationship between intestinal barrier function and intestinal environment in healthy subjects
Scientific Title:Acronym
Test to evaluate the relationship between intestinal barrier function and intestinal environment in healthy subjects
Region
| Japan |
Condition
Condition
Men and Women
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measurement of intestinal barrier function values in healthy subjects and analysis of the relationship with the intestinal environment
Basic objectives2
Others
Basic objectives -Others
Research
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Urinary lactulose-mannitol ratio
Key secondary outcomes
Urinary lactulose concentration
Urinary mannitol concentration
Gut microbiota
Gut metabolite
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
| Vaccine | Food |
Interventions/Control_1
Single dose of sugar solution which contains lactulose 10g and mannitol 5g
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Men and women between 20 and 80 years
(2) Subjects who have received enough explanation about this study and were able to understand that, then giving written informed consent.
Key exclusion criteria
(1) Regular use of certain medicines.
(2) Current history of serious illness.
(3) Allergy to foods containing sugar alcohols.
(4) Subjects who aware that they are prone to diarrhea due to consumption of foods containing sugar alcohols.
(5) Subjects who have been pointed out about glucose tolerance and/or renal function from medical checkup and/or doctor within past one year.
(6) Subjects who have been determined as ineligible for participating the research by study director.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Murakami |
Organization
Meatgen, Inc.
Division name
Headquarters
Zip code
997-0051
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
+81-235-64-0330
research@metagen.co.jp
Public contact
Name of contact person
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Murakami |
Organization
Metagen, Inc.
Division name
Headquarters
Zip code
997-0051
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
+81-235-64-0330
Homepage URL
research@metagen.co.jp
Sponsor or person
Institute
Metagen, Inc.
Institute
Department
Personal name
Funding Source
Organization
Self Funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiyoda Paramedical Care Clinic
Address
3-3-5 Uchikanda, Chiyoda-ku, Tokyo
Tel
03-5297-5548
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
| 2022 | Year | 03 | Month | 07 | 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
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 04 | Day |
Last modified on
| 2023 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053702
