UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for evaluating the effect of the intake of a lactobacillus-containing food on immune system in adults with lower salivary secretory immunoglobulin A (s-IgA) secretion rate : randomized, placebo-controlled, double blind trial
Title of the study (Brief title)	A study for evaluating the effect of the intake of a lactobacillus-containing powder on immune system in adults with lower salivary secretory immunoglobulin A (s-IgA) secretion rate
Region	Japan

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

Objectives
Narrative objectives1	This study aims to evaluate the effects of ingestion of lactobacillus -containing food for 12 consecutive weeks on immune function in subjects with lower salivary secretory immunoglobulin A (s-IgA) secretion rate.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Salivary s-IgA secretion rate
Key secondary outcomes	Salivary s-IgA concentration

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	Ingestion of test food containing lactobacillus for 12 consecutive weeks
Interventions/Control_2	Ingestion of placebo without lactobacillus for 12 consecutive 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

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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Males and females from 20 to 64 years of age 2) A lower salivary secretory immunoglobulin A secretion rate
Key exclusion criteria	1) Subjects who routinely use (more than 3 times a week) food or medicine containing of lactobacillus 2) Subjects routinely taking dietary supplements which may influence immune function 3) Subjects who has history of the allergic disease 4) Subjects who are under medication which may influence the outcome of the study (e.g., hyposensitization) 5) Subjects who are have treated oral or dental care within the last one month prior to the current study or are planned to treat oral or dental care 6) Subjects who has oral or dental problems with bleeding 7) Night and day shift worker or manual laborer 8) Subjects who has carries out an intense activity (e.g., marathon race) 9) Subjects who cannot carry out a procedure of various inspection by the rule during the study period 10) Subjects who has a disease under treatment or are judged to that medical treatment are necessary by the doctor 11) Subjects who has under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) and disease to affect the adrenal cortical hormone secretion 12) Subjects having possibilities for emerging allergy related to the study 13) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination 14) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating 15) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study 16) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire 17) Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size	60

Research contact person
Name of lead principal investigator	Takehisa Kumagai
Organization	KAMEDA SEIKA Co., Ltd.
Division name	Rice research center
Address	3-1-1, Kameda Kogyo Danchi, Konan-ku, Niigata City, Niigata
TEL	025-382-8879
Email	t_kumagai@sk.kameda.co.jp

Public contact
Name of contact person	Hiroyasu Shimada
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Address	1-20-2, Ebisunishi, shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	h.shimada@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd.
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	KAMEDA SEIKA Co., Ltd.
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

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 25 Day
Anticipated trial start date	2015 Year 07 Month 26 Day
Last follow-up date	2015 Year 12 Month 12 Day
Date of closure to data entry	2015 Year 12 Month 29 Day
Date trial data considered complete	2016 Year 01 Month 12 Day
Date analysis concluded	2016 Year 02 Month 22 Day

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

Management information
Registered date	2015 Year 07 Month 25 Day
Last modified on	2016 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021321