UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032609 |
|---|---|
| Receipt number | R000037182 |
| Scientific Title | The effect of oral probiotics for healthy adults |
| Date of disclosure of the study information | 2018/10/31 |
| Last modified on | 2020/05/19 09:28:25 |
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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 | Yasuhiro |
| Middle name | |
| Last name | Koga |
Organization
Tokai University School of Medicine
Division name
Gastroenterology
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
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
pct@k.nifty.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
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
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
29
Results
BOP was significantly different between the LS1 group and the placebo group at 12 weeks of administration. LS1 tablet confection maintained healthy gingiva for adults with healthy periodontal tissue compared to placebo tablet confection.
Results date posted
| 2020 | Year | 05 | Month | 19 | Day |
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
| 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
| 2020 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037182
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
