UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study for evaluating the effects of food containing lactic acid bacteria on immune function. - A randomized, double-blind, placebo-controlled, parallel-group comparative method -
Acronym	A clinical study for evaluating the effects of food containing lactic acid bacteria on immune function.
Scientific Title	A clinical study for evaluating the effects of food containing lactic acid bacteria on immune function. - A randomized, double-blind, placebo-controlled, parallel-group comparative method -
Scientific Title:Acronym	A clinical study for evaluating the effects of food containing lactic acid bacteria on immune function.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effects of continuous intake of food containing lactic acid bacteria on immune function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Physical health questionnaire (local symptoms, systemic symptoms, general symptoms)
Key secondary outcomes	Salivary sIgA (concentration, secretion rate, secretion amount) NK cell activity Serum IgA level Serum IgG level Serum d-ROMs level Serum BAP level Body temperature POMS 2 Adult Forms

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	Ingest the yogurt drink containing the target lactic acid bacteria every day for 12 weeks.
Interventions/Control_2	Ingest the yogurt drink without the target lactic acid bacteria every day for 12 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. Japanese males and females aged from 20 to 64 years old. 2. Subjects who often catch colds or get poor physical conditions. 3. Subjects who received a sufficient explanation of the purpose and contents of this examination, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document.
Key exclusion criteria	Subjects (who) 1. suffering from, undergoing treatment for, or with a history of serious diseases. 2. have chronic diseases and take medication on a daily basis. 3. have been diagnosed as dry mouth. 4. are unable to abstain from taking supplement, food for specified health use or functional food, or health food that may affect immune function. 5. are unable to abstain from taking food that containing lactic acid bacteria, bifidobacterium, oligosaccharides, or viable bacteria during the study. 6. consistently drink more than the appropriate amount of alcohol. 7. are unable to abstain from alcohol for 2 days prior to screening test and each test. 8. have food allergies. 9. take or have the plan to take medicine for pollen allergy. 10. with digestive diseases affecting digestion and absorption and with a history of digestive surgery (excluding appendicitis). 11. tend to get diarrhea by taking dairy products. 12. are pregnant women, women who intend to become pregnant during the research period, and women who are breastfeeding. 13. are judged to be inappropriate as research subjects by blood tests in screening tests. 14. have a history or current condition of drug or alcohol dependence. 15. are participating in research involving the ingestion of other foods or the use of other medicines or who have participated within one month of obtaining consent, and those who are willing to participate. 16. are judged to be inappropriate as research subjects by the principal investigator. 17. smoke 21 or more cigarettes a day. 18. have the plan to receive the influenza vaccine from 3 weeks before ingestion to the end of the ingestion period. 19. have the plan to receive the COVID-19 vaccine during the ingestion period. 20. work on night shift. 21. plan to travel abroad during the study. 22. has donated more than 200 mL of blood within 1 month or 400 mL of blood within 3 months prior to the date of obtaining consent, or donated blood components.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Yoshitaka Middle name Last name Iwama
Organization	Nihonbashi Cardiology Clinic
Division name	Director
Zip code	103-0001
Address	Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL	03-5641-4133
Email	yiwama@well-sleep.jp

Public contact
Name of contact person	1st name Eiji Middle name Last name Yoshikawa
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0023
Address	Shibaura Omodaka Building 7F, 1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	eigyou27@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	MEGMILK SNOW BRAND 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	Ethical Committee of Nihonbashi Cardiology Clinic
Address	Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel	03-5641-4133
Email	niho-jimucho@well-sleep.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	2022 Year 09 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	2021 Year 09 Month 29 Day
Date of IRB	2021 Year 09 Month 29 Day
Anticipated trial start date	2021 Year 10 Month 30 Day
Last follow-up date	2022 Year 04 Month 24 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 10 Month 28 Day
Last modified on	2022 Year 09 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052403