UMIN-CTR Clinical Trial

Basic information
Public title	A study for immunostimulatory effects of intake of spore-forming lactic acid bacteria in adult men and women
Acronym	A study for immunostimulatory effects of intake of spore-forming lactic acid bacteria in adult men and women
Scientific Title	A study for immunostimulatory effects of intake of spore-forming lactic acid bacteria in adult men and women
Scientific Title:Acronym	A study for immunostimulatory effects of intake of spore-forming lactic acid bacteria in adult men and women
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the immunostimulatory effects of spore-forming lactic acid bacteria intake for 8 weeks
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Physical condition questionnaire s-IgA (Saliva) IgA (Fecal)
Key secondary outcomes	POMS2 SF-36 Blood markers (Inflammation,Immune,Stress)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of test food daily intake, for 8 weeks
Interventions/Control_2	Intake of placebo daily intake, for 8 weeks
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Healthy working men and women between the ages of 20 and 64. (2) Those with low saliva s-IgA during screening. (3) Those who are prone to colds and flu. (4) Those who suffered from upper respiratory tract infections in the winter of the last two years. (5) Those who have received sufficient explanation of the purpose and content of this examination, have the ability to consent, and have volunteered to participate voluntarily after understanding well, who have agreed to participate in this examination in writing.
Key exclusion criteria	(1) Subjects having a disease or a history of serious diseases for which medication was required. (2) Subjects who have chronic diseases and use drugs. (3) Subjects who cannot stop the consumption of foods containing the components involved in test foods during the study period. (4) Subjects who routinely use health food containing involvement ingredients. (5) Subjects who get treatment affecting the test results. (6) Subjects who cannot abstinence from 2 days before the inspection. (7) Subjects having possibilities for emerging allergy related to the study. (8) Subjects who have a history of digestive disorders and digestive surgery that affect digestion and absorption. (9) Subjects who have experienced abnormal clinical test values or cardiopulmonary function and have been judged to have problems participating in the study. (10) Subjects who have a history of drug dependence, alcohol dependence, or current medical history. (11) Subjects who are prone to diarrhea when consuming dairy products. (12) Night and day shift worker or manual laborer. (13) Subjects who are or plan to perform dental care one month prior to pre-examination, currently, or during the study period. (14) Subjects who have oral or dental problems with bleeding or develops the trouble. (15) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination. (16) Subjects who participated in other clinical studies and those who are willing to participate during the study period. (17) Subjects who are planned to become pregnant or lactating. (18) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire. (19) Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Noriyoshi Middle name Last name Uchida
Organization	Mitsubishi-Chemical Foods Corporation
Division name	Foods and Nutritions Science Div.
Zip code	100-8251
Address	1-1-1,Marunouchi,Chiyoda-ku,Tokyo, Japan
TEL	03-6748-7426
Email	uchida.noriyoshi.mp@m-chemical.co.jp

Public contact
Name of contact person	1st name Shingo Middle name Last name Yamamichi
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Zip code	162-0822
Address	Tsuruya Bldg., 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo, Japan
TEL	03-5657-4983
Homepage URL
Email	yamamichi578@eps.co.jp

Sponsor
Institute	TTC Co., Ltd
Institute
Department

Funding Source
Organization	Mitsubishi-Chemical Foods Corporation
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, Meguroku, 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 01 Month 08 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	2020 Year 12 Month 24 Day
Date of IRB	2020 Year 12 Month 24 Day
Anticipated trial start date	2021 Year 01 Month 09 Day
Last follow-up date	2021 Year 04 Month 26 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 01 Month 07 Day
Last modified on	2021 Year 07 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049013