UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044335 |
|---|---|
| Receipt number | R000050637 |
| Scientific Title | Effect of intake of heat-killed lactic acid bacteria on the oral function. |
| Date of disclosure of the study information | 2023/05/30 |
| Last modified on | 2021/12/27 13:37:48 |
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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
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
y-kohzai@kyowa-t.com
Sponsor or person
Institute
Akanuma Surgery Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050637
