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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032609
Receipt No. R000037182
Scientific Title The effect of oral probiotics for healthy adults
Date of disclosure of the study information 2018/10/31
Last modified on 2019/08/29

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Basic information
Public title The effect of oral probiotics for healthy adults
Acronym The effect of oral probiotics for healthy adults
Scientific Title The effect of oral probiotics for healthy adults
Scientific Title:Acronym The effect of oral probiotics for healthy adults
Region
Japan

Condition
Condition periodontal disease
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Gingiva condition of healthy adults improves by administration of lactic acid bacteria.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Bleeding of probing
Key secondary outcomes probing depth
plaque control record
bacterial naumber
IgA

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 Treatment
Type of intervention
Food
Interventions/Control_1 Lactobacillus salivarius TI2711
Interventions/Control_2 placebo
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria healthy adults
PD of 4 mm or more is 10% or less, BOP is 10% or less
Key exclusion criteria PD of 4 mm or more is 10% or more, BOP is 10% or more
Target sample size 75

Research contact person
Name of lead principal investigator
1st name Katsunaka
Middle name
Last name Mikami
Organization Tokai University School of Medicine
Division name Psychiatry
Zip code 259-1193
Address 143 Shimokasuya, Isehara, Kanagawa
TEL 0463-93-1121
Email yasuhiro@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Matsuoka
Organization Tokai University School of Medicine
Division name Psychiatry
Zip code 259-1193
Address 143 Shimokasuya, Isehara, Kanagawa
TEL 0463-93-1121
Homepage URL
Email pct@k.nifty.jp

Sponsor
Institute Tokai University School of Medicine
Institute
Department

Funding Source
Organization KOIKE-YA Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Hiyoshi oral Helth Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board for Clinical Research, Tokai University
Address 143 Shimokasuya, Isehara, Kanagawa
Tel 0463-93-1121
Email tokai-rinsho@ml.tokai-u.jp

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 東海大学医学部(神奈川県)
日吉歯科診療所(山形県)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 31 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 No longer recruiting
Date of protocol fixation
2018 Year 03 Month 22 Day
Date of IRB
2018 Year 01 Month 26 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
2019 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 16 Day
Last modified on
2019 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037182

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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