UMIN-CTR Clinical Trial

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