UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047263 |
|---|---|
| Receipt number | R000053905 |
| Scientific Title | Analysis of gene expression profiles of Lacticaseibacillus paracasei strain Shirota from human faeces after drinking products containing LcS. |
| Date of disclosure of the study information | 2022/04/16 |
| Last modified on | 2022/05/17 15:40:31 |
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Basic information
Public title
Analysis of gene expression profiles of Lacticaseibacillus paracasei strain Shirota from human faeces after drinking products containing LcS.
Acronym
Analysis of gene expression profiles of Lacticaseibacillus paracasei strain Shirota from human faeces after drinking products containing LcS.
Scientific Title
Analysis of gene expression profiles of Lacticaseibacillus paracasei strain Shirota from human faeces after drinking products containing LcS.
Scientific Title:Acronym
Analysis of gene expression profiles of Lacticaseibacillus paracasei strain Shirota from human faeces after drinking products containing LcS.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the gene expression profiling of LcS after passage through the human intestinal tract.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gene expression profile of LcS in faeces after 4 and 7 days of treatment.
Key secondary outcomes
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
Test food: Yakult 1000, Intervention period: 7 days, Amount of interventions:First 4 days 1 bottle per day, Last 3 days 3 bottles per day.
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
| 18 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
Subjects with habitual constipation or diarrhoea.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Ooishi |
Organization
Yakult Central Institute
Division name
Gastrointestinal Function Research Laboratory Basic Research Department
Zip code
186-8650
Address
5-11 Izumi, Kunitachi-shi, Tokyo, 186-8650 Japan
TEL
042-577-8921
kenji-ooishi@yakult.co.jp
Public contact
Name of contact person
| 1st name | Toshihiko |
| Middle name | |
| Last name | Takada |
Organization
Yakult Central Institute
Division name
Gastrointestinal Function Research Laboratory Basic Research Department
Zip code
186-8650
Address
5-11 Izumi, Kunitachi-shi, Tokyo, 186-8650 Japan
TEL
042-577-8921
Homepage URL
toshihiko-takada@yakult.co.jp
Sponsor or person
Institute
Yakult Central Institute
Institute
Department
Personal name
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
Chiyoda Paramedical Care Clinic Institutional Review Board
Address
Daiwa Building 2F, 3-3-10, Nihonbashi Hogokucho, Chuo-ku, Tokyo
Tel
03-6225-9005
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 | 04 | Month | 16 | 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
6
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 | 04 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 16 | 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 | 23 | Day |
Last modified on
| 2022 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053905
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
