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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036767
Receipt No. 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

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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
Email 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
Email cpcc-contact@cpcc.co.jp

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, JAPAN
Tel 042-632-5900
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041860

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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