UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036767 |
|---|---|
| Receipt number | R000041860 |
| Scientific Title | A study on survival of a bacterial strain of Lactobacillus sp. in the human gastrointestinal tract. |
| Date of disclosure of the study information | 2019/05/19 |
| Last modified on | 2019/09/09 14:03:52 |
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Basic information
Public title
A study on survival of a bacterial strain of Lactobacillus sp. in the human gastrointestinal tract.
Acronym
A study on survival of a bacterial strain of Lactobacillus sp. in the human gastrointestinal tract.
Scientific Title
A study on survival of a bacterial strain of Lactobacillus sp. in the human gastrointestinal tract.
Scientific Title:Acronym
A study on survival of a bacterial strain of Lactobacillus sp. in the human gastrointestinal tract.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure the cell number of a bacterial strain of Lactobacillus sp. in the human gastrointestinal tract of volunteers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Viable cell number of a lactobacillus strain in feces
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
Ingestion of test food for 3 days
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) Age 20-59
2) Individuals who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
1) Seriously or progressive ill patients
2) Individuals who use regularly pharmaceuticals or supplements that contain lactobacilli.
3) Individuals who have a history of digestive diseases.
4) Individuals who intakook dairy products that contain a certain Lactobacillus strain within the past month.
5) Pregnant or breast feeder.
6) Individuals who have lactose intolerance or an allergy to dairy products.
7) Individuals with a tendency for constipation, whose frequency of defecation is less than 3 times per week.
8) Individuals who have diarrhea at least once a week.
9) Individuals who received antibiotics within the past month.
10) Individuals who participated in other clinical trials within the past month.
11) Individuals who show apparent abnormal value in clinical examination.
12) Others who have been determined ineligible by principal investigator or physician.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kano |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachiouji, Tokyo, JAPAN
TEL
042-632-5842
hiroshi.kano@meiji.com
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Plan Sales Department
Zip code
101-0047
Address
4F Sanwanaikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo, JAPAN
TEL
03-5927-3112
Homepage URL
cpcc-contact@cpcc.co.jp
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, JAPAN
Tel
042-632-5900
MEIJI.IRB@meiji.com
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
| 2019 | Year | 05 | 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
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 | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 16 | Day |
Last modified on
| 2019 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041860
| Research Plan | |
|---|---|
| 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 |
