UMIN-CTR Clinical Trial

Basic information
Public title	Safety evaluation of excessive intake of food containing lactic acid bacteria
Acronym	Safety evaluation of excessive intake of food containing lactic acid bacteria
Scientific Title	Safety evaluation of excessive intake of food containing lactic acid bacteria
Scientific Title:Acronym	Safety evaluation of excessive intake of food containing lactic acid bacteria
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study the safety of a daily intake of 300mL of a test food containing lactic acid bacteria for 4 consecutive weeks.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hematologic test Blood biochemistry test Urine analysis Blood pressure/pulsation Body weight/body mass index Doctor's question Adverse event
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	Intake of test food for 4 consecutive weeks
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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy males and females from 20 to 64 years old
Key exclusion criteria	(1) Subjects who are judged as unsuitable for the study based on the results of the lifestyle questionnaire (2) Subjects who have serious disease or history of those illnesses (e.g., diabetes, liver disease, kidney disease, heart disease, respiratory disease, endocrine diseases, or metabolic disease) (3) Subjects who are judged as unsuitable for the study based on the results of clinical examination or cardiopulmonary abnormality (4) Subjects having possibilities for emerging allergy related to the study (5) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (6) Subjects who have participated in other clinical studies (7) Subjects who intend to become pregnant or lactating during the test period (8) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Kenji Middle name Last name Uchida
Organization	Yotsuba Milk Products Co., Ltd.
Division name	Research Division R&D Center
Zip code	061-1264
Address	465-1,Wattsu,Kitahiroshima-shi,Hokkaido
TEL	011-377-5561
Email	uchida_k@yotsuba.co.jp

Public contact
Name of contact person	1st name Nahomi Middle name Last name Noji
Organization	EP Mediate Co., Ltd.
Division name	Development Business Headquarters, TTC Center, Trial Planning Department
Zip code	162-0822
Address	Tsuruya Bldg., 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo
TEL	03-5657-4983
Homepage URL
Email	noji590@eps.co.jp

Sponsor
Institute	EP Mediate Co., Ltd.
Institute
Department

Funding Source
Organization	Yotsuba Milk Products 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	Medical Station Clinic Research Ethics Committee
Address	3-12-8, Takaban, Meguro-ku, Tokyo
Tel	03-6452-2712
Email	saito876@eps.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	2021 Year 07 Month 01 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	2021 Year 06 Month 10 Day
Date of IRB	2021 Year 06 Month 10 Day
Anticipated trial start date	2021 Year 07 Month 02 Day
Last follow-up date	2021 Year 09 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 07 Month 01 Day
Last modified on	2021 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051069