UMIN-CTR Clinical Trial

Basic information
Public title	A study for evaluating the effects of intake of food containing lactic acid bacteria on immunological functions - A randomized, single-blind, placebo-controlled trial.
Acronym	A study for evaluating the effects of intake of food containing lactic acid bacteria on immunological functions.
Scientific Title	A study for evaluating the effects of intake of food containing lactic acid bacteria on immunological functions - A randomized, single-blind, placebo-controlled trial.
Scientific Title:Acronym	A study for evaluating the effects of intake of food containing lactic acid bacteria on immunological functions.
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

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

Assessment
Primary outcomes	IgA flow rate of saliva
Key secondary outcomes	Conditioning questionnaire, concentration of IgA in saliva, saliva flow rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) 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	Food containing lactic acid bacteria for 8 weeks
Interventions/Control_2	Placebo (not containing lactic acid bacteria) 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	60 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Males and females from 20 to 59 years of age (2) Subjects giving written informed consent
Key exclusion criteria	(1) Individuals taking antiflatulents and/or laxatives (including purgative drug) and/or drugs which may affect immune function in common use (2) Individuals taking antibiotics and/or drugs which may affect digestion and absorption in common use (3) Individuals taking excessive amounts of foods containing lactic acid bacteria, bifidobacteria, natto bacteria, and/or other health foods including food for specified health use and food with function claim, which influence immune function (4) Individuals presenting known food allergy (5) Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period (6) Individuals who have previous and/or current medical history of diseases (e.g., diabetes, liver disease, kidney disease, kidney disease) and/or immune-mediated diseases (e.g., atopic dermatitis, asthma, autoimmune disease) (7) Individuals who are under treatment or have a history of drug/alcohol dependence (8) Individuals who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics (9) Individuals who are judged as unsuitable for the study by the investigator for the other reasons
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Tomonori Middle name Last name Ando
Organization	Lotte Co., Ltd.
Division name	Central Laboratory, Food material development section
Zip code	336-8601
Address	1-1, Numakage-3chome, Minami-ku, Saitama
TEL	048-837-0187
Email	andou_tomonori@lotte.co.jp

Public contact
Name of contact person	1st name Tomonori Middle name Last name Ando
Organization	Lotte Co., Ltd.
Division name	Central Laboratory , Food material development section
Zip code	336-8601
Address	1-1, Numakage-3chome, Minami-ku, Saitama
TEL	048-837-0187
Homepage URL
Email	andou_tomonori@lotte.co.jp

Sponsor
Institute	Lotte Co., Ltd.
Institute
Department

Funding Source
Organization	Lotte Co., Ltd.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shiba Palace Clinic Ethics Review Communittee
Address	DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo
Tel	03-5408-1590
Email	jimukyoku@mail.souken-r.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	2020 Year 10 Month 13 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 10 Month 08 Day
Date of IRB	2020 Year 08 Month 17 Day
Anticipated trial start date	2020 Year 10 Month 14 Day
Last follow-up date	2020 Year 10 Month 16 Day
Date of closure to data entry	2020 Year 10 Month 16 Day
Date trial data considered complete	2020 Year 10 Month 16 Day
Date analysis concluded	2020 Year 11 Month 06 Day

Other
Other related information

Management information
Registered date	2020 Year 10 Month 06 Day
Last modified on	2021 Year 10 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047959