UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of the yogurt fermented with Lactobacillus delbrueckii ssp. bulgaricus OLL1073R-1 on the IgA flow rate of saliva in elderly persons residing in a nursing home
Title of the study (Brief title)	Effects of the yogurt on the IgA flow rate of saliva in elderly persons.
Region	Japan

Condition
Condition	upper respiratory tract infection
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Clarify whether the yogurt fermented with L. bulgaricus OLL1073R-1 intake increases the IgA level in saliva of the elderly person
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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	The participants ingested 112 g of the yogurt fermented with L. bulgaricus OLL1073R-1 each day in the morning (10:00 a.m. to 10:30 a.m.) for 12 weeks.Saliva samples were obtained in the morning (9:30 to 10:30 a.m.) before (0 weeks) and after 4, 8, and 12 weeks of the yogurt intake.
Interventions/Control_2
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	The elderly persons who are entering the same special elderly nursing home
Key exclusion criteria	Individuals taking antibiotics or morphine, with gastric fistulae, who disliked yogurt
Target sample size	40

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-Cho, Yokosuka, Kanagawa, 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	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	寒川ホーム

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 10 Day
Anticipated trial start date	2013 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2014 Year 01 Month 31 Day
Date analysis concluded	2017 Year 05 Month 18 Day

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Publication of results	Unpublished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

Management information
Registered date	2017 Year 05 Month 18 Day
Last modified on	2017 Year 05 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031394