UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of the effects of yogurt fermented with Lactobacillus delbrueckii ssp. bulgaricus OLL1073R-1 on the immunity function in elderly persons
Title of the study (Brief title)	The study of the effects of yogurt on the immunity function
Region	Japan

Condition
Condition	weakened immune systems
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Elucidation of the effect that a yogurt intake gives in salivary IgA
Basic objectives2	Others
Basic objectives -Others	Elucidation whether or not a yogurt intake increases total salivary IgA. Elucidation whether or not a yogurt intake increases salivary IgA intersecting to influenza virus.
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	salivary IgA
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
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	The participants ingested 100 g of yogurt fermented with L. bulgaricus OLL1073R-1 each day in the morning for 12 weeks.
Interventions/Control_2	The participants ingested 100 g of yogurt fermented with other lactobacillus each day in the morning 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	65 years-old <=
Age-upper limit	105 years-old >=
Gender	Male and Female
Key inclusion criteria	Elderly volunteers residing in elderly nursing homes
Key exclusion criteria	Individuals taking antibiotics or morphine, with gastric fistulae, who disliked yogurt
Target sample size	100

Research contact person
Name of lead principal investigator	Keiichi Tsukinoki
Organization	Kanagawa Dental University, Graduate School of Dentistry
Division name	Environmental Pathology
Address	82 Inaoka, Yokosuka, Kanagawa 2388580, Japan
TEL	046-822-8866
Email	tsukinoki@kdu.ac.jp

Public contact
Name of contact person	Yuko Yamamoto
Organization	Department of Junior College, Kanagawa Dental University
Division name	School of Dental Hygiene
Address	82 Inaoka-Cho, Yokosuka, Kanagawa, Japan
TEL	046-822-8755
Homepage URL
Email	yamamoto.yuko@kdu.ac.jp

Sponsor
Institute	Kanagawa Dental University
Institute
Department

Funding Source
Organization	Meiji 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	2017 Year 08 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 10 Day
Anticipated trial start date	2014 Year 09 Month 01 Day
Last follow-up date	2014 Year 12 Month 31 Day
Date of closure to data entry	2018 Year 12 Month 31 Day
Date trial data considered complete	2018 Year 12 Month 31 Day
Date analysis concluded	2018 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 10 Day
Last modified on	2017 Year 08 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032773