UMIN-CTR Clinical Trial

Basic information
Public title	A Study of Preventive Effect of Lactic Acid Bacteria against Common Cold and Influenza Infection
Acronym	A Study of Preventive Effect of Lactic Acid Bacteria against Common Cold and Influenza Infection
Scientific Title	A Study of Preventive Effect of Lactic Acid Bacteria against Common Cold and Influenza Infection
Scientific Title:Acronym	A Study of Preventive Effect of Lactic Acid Bacteria against Common Cold and Influenza Infection
Region	Japan

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

Objectives
Narrative objectives1	Evaluating the Effects of Oral Intake of Lactic Acid Bacteria on Pathogenesis of Common Cold and Influenza-like Illness and Immunological Response.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Daily questionnaire symptoms based on Common Cold and influenza-like illness
Key secondary outcomes	Immunological test using bloods collected before and after the intake period (12 weeks)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
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	Lactic acid bacteria, 1 food per day for 12 weeks.
Interventions/Control_2	Placebo (not containing lactic acid bacteria), 1 food per 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	18 years-old <=
Age-upper limit	39 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Subjects aged 18 to 39 years old. (2)Subjects giving written informed consent.
Key exclusion criteria	(1)Subjects who are judged as unsuitable for the study by the investigator for the other reasons. (2)Subjects taking any kind of medicine which affect the result of the trial for habitual use. (3)Pregnant women, lactating women. (4)Subjects with serious hepatic, renal, and cardiovascular dysfunction (including anamnesis).
Target sample size	800

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoaki Ishii
Organization	Tokai University
Division name	School of Medicine
Zip code
Address	143 Shimokasuya, Isehara-city, Kanagawa, Japan
TEL	0463-93-1121
Email	nishii@is.icc.u-tokai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takashige Oroguchi
Organization	Tokai University
Division name	School of Medicine
Zip code
Address	143 Shimokasuya, Isehara-city, Kanagawa, Japan
TEL	0463-93-1121
Homepage URL
Email	oroguchi@is.icc.u-tokai.ac.jp

Sponsor
Institute	Tokai University
Institute
Department

Funding Source
Organization	Kirin 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
Address
Tel
Email

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	東海大学

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 29 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	2013 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date	2013 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 07 Month 29 Day
Last modified on	2015 Year 07 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021394

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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