UMIN-CTR Clinical Trial

Basic information
Public title	Effect of intake of heat-killed lactic acid bacteria on the oral function.
Acronym	Effect of intake of heat-killed LAB on the oral function.
Scientific Title	Effect of intake of heat-killed lactic acid bacteria on the oral function.
Scientific Title:Acronym	Effect of intake of heat-killed LAB on the oral function.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate effects of intake of heat-killed LAB on the oral function.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Bleeding on probing, Gingival index, Probing pocket depth, Plaque index, Preriodontpathic bacteria, Tanque coating, Halitosis
Key secondary outcomes	Salivary flow

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of heat-killed LAB (high dose) for 6 weeks
Interventions/Control_2	Ingestion of heat-killed LAB (low dose) for 6 weeks
Interventions/Control_3	Ingestion of placebo for 6 weeks
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	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	A health parson without a illness
Key exclusion criteria	1.Persons with severe periodontal disease 2.Persons who take drugs for adiposity, hypertension and dyslipidemia 3.Persons who cannot give up the intake of possible supplements which may affect the status of fat, blood pressure and plasma lipids 4.Persons who cannot terminate the consumption of foods containing large number of lactic acid bacteria during the trial
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Masanori Middle name Last name Akanuma
Organization	Akanuma Surgery Clinic
Division name	Department
Zip code	0050842
Address	14-1, Isiyama2-jo 6, , Minami-ku Sapporo-shi, Hokkaido
TEL	0112009431
Email	y-kohzai@kyowa-t.com

Public contact
Name of contact person	1st name Yoshimichi Middle name Last name kozai
Organization	Kyowa Trial Co., Ltd.
Division name	Clinical Trials Division
Zip code	0640923
Address	1-40, minami 2-jo nisi 11-tyoume, , tyuuou-ku Sapporo-shi, Hokkaido
TEL	08018692585
Homepage URL
Email	y-kohzai@kyowa-t.com

Sponsor
Institute	Akanuma Surgery Clinic
Institute
Department

Funding Source
Organization	Asahi quality & innovations , 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	Akanuma Surgery Clinic ethics committee
Address	14-1, Isiyama2-jo 6, , Minami-ku Sapporo-shi, Hokkaido
Tel	0112009431
Email	s-ito@kyowa-t.com

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	赤沼外科医院

Other administrative information
Date of disclosure of the study information	2023 Year 05 Month 30 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	2021 Year 03 Month 11 Day
Date of IRB	2021 Year 03 Month 17 Day
Anticipated trial start date	2021 Year 05 Month 31 Day
Last follow-up date	2021 Year 07 Month 25 Day
Date of closure to data entry	2021 Year 08 Month 27 Day
Date trial data considered complete	2021 Year 08 Month 27 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 26 Day
Last modified on	2021 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050637