UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for evaluating the effects of oral intake of lactic acid bacteria on immune function after exercise. A randomized, double-blind, placebo- controlled trial.
Title of the study (Brief title)	A study for evaluating the effects of oral intake of lactic acid bacteria on immune function after exercise.
Region	Japan

Condition
Condition	None (Healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of oral administration of lactic acid bacteria on immune functions after exercise.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Activities of dendritic cells and the immune-reaction of peripheral blood mononuclear cells to the stimulation of inactivated viruses (interferon-alpha production, and anti-viral genes expression), conditioning questionnaire.
Key secondary outcomes	Immune activity, stress hormone amount, and cytokine amount of blood, salivary immune activity and stress hormone amount, conditioning questionnaire.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Lactic acid bacteria, 1 portion of food per day for 13 days.
Interventions/Control_2	Placebo (not containing lactic acid bacteria), 1 portion of food per day for 13 days.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Males and females aged more than 20 years old, when giving the informed consent. 2)Individuals who have daily exercise. 3)Individuals who are received enough explanation of the purpose and the details of this study, who are decided to attend this study with their own will, who have ability of agreement, and who submit the informed consents in writing.
Key exclusion criteria	1)Individuals who can&#39;t stop drinking for 2 days before the days of screening and checkup. 2)Individuals who can&#39;t stop eating foods containing lactic acid bacteria and/or oligosaccharide, fermented foods during this study. 3)Individuals who can&#39;t stop eating functional foods which may affect immune functions. 4)Individuals who have a history of irritable bowel syndrome and Crohn&#39;s disease. 5) Individuals who have a medical history of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder. 6)Individuals who have chronic diseases and use medicines continuously. 7)Individuals who have under treatment or a history of drug addiction and/or alcoholism. 8)Individuals who are judged as unsuitable for this study based on the results of blood test. 9)Individuals with excessive alcohol-drinking behaviors. 10)Individuals who have a medical history of diseases affecting digestion and absorption. 11)Individuals who are pregnant, breastfeeding, or planning to be pregnant in the near future. 12)Individuals who are participating or willing to participate in other clinical trials. 13)Individuals whose family works for a company manufacturing or selling healthy foods or functional foods. 14)Individuals with steroid treatment. 15)Individuals who are seropositive against HBV antigen, HCV antibody, HIV antibody, or HTLV-1 antibody. 16)Individuals who are judged unsuitable for this study by the investigator for other reasons.
Target sample size	70

Research contact person
Name of lead principal investigator	Hiroyuki Daida
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Address	2-1-1 Hongo Bunkyo-ku, Tokyo Japan
TEL	03-3813-3111
Email	daida@juntendo.ac.jp

Public contact
Name of contact person	Kazunori Shimada
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Address	2-1-1 Hongo Bunkyo-ku, Tokyo Japan
TEL	03-3813-3111
Homepage URL
Email	shimakaz@juntendo.ac.jp

Sponsor
Institute	Juntendo University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Kirin Company, Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	順天堂大学大学院医学研究科／Juntendo University Graduate School of Medicine

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 01 Day
Anticipated trial start date	2016 Year 01 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 12 Month 28 Day
Last modified on	2016 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023530