UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053172 |
|---|---|
| Receipt number | R000060505 |
| Scientific Title | Effects of ingesting heat-killed bifidobacteria for 5 weeks on the salivary IgA: A randomized, double-blind, placebo-controlled, parallel-group study |
| Date of disclosure of the study information | 2023/12/20 |
| Last modified on | 2023/12/20 11:41:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of ingesting heat-killed bifidobacteria for 5 weeks on the oral condition
Acronym
Effects of ingesting bifidobacteria on the oral condition
Scientific Title
Effects of ingesting heat-killed bifidobacteria for 5 weeks on the salivary IgA: A randomized, double-blind, placebo-controlled, parallel-group study
Scientific Title:Acronym
Effects of ingesting heat-killed bifidobacteria for 5 weeks on the salivary IgA
Region
| Japan |
Condition
Condition
N/A (Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of ingesting heat-killed bifidobacteria on the salivary IgA and oral condition
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary IgA and IgA per mg of protein
Key secondary outcomes
Oral condition and safety
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food: One g of granule dextrin contained 40 mg of non-live bifidobacteria powder (more than 0.5 x 10^10 non-live cells per 1 g of the test food)
Administration: Oral intake of test food twice a day for 5 weeks
Interventions/Control_2
Placebo food: One g of granule dextrin
Administration: Oral intake of placebo food twice a day for 5 weeks
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
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Healthy females of 20 to 40 years age
2. Subjects with more than 4 measurable teeth in the 6 index teeth (teeth nos. 16, 21, 24, 36, 41, and 44) or substitutional neighboring teeth (teeth nos. 17, 15, 11, 22, 25, 37, 35, 31, 42, 45)
3. Subjects without undergoing treatment for caries or periodontal disease
4. Subjects with more than 20 teeth
5. Subjects giving written informed consent
Key exclusion criteria
1. Subjects with severe caries or periodontal disease
2. Subjects with removable dentures
3. Subjects who have took in antibiotic or antibacterial agent within the last month to the screening test
4. Pregnant, possibly pregnant during this study, or lactating women
5. Subjects with sever systemic diseases affecting the results of this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Terahara |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
TEL
81-42-632-5846
masaki.terahara@meiji.com
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
7F Shibaura Omodaka Bldg. 1-9-7 Shibaura, Minato-ku, Tokyo
TEL
81-3-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., 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
Meiji Institutional Review Board
Address
1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
Tel
81-42-632-5900
MEIJI.IRB@meiji.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
柳澤デンタルオフィス（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 20 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
30
Results
Salivary IgA concentration and IgA concentration per mg of protein (IgA/Pro) after intake period were not significantly different between groups. In the subgroup analyses, except for subjects with probable infections, the change in IgA/Pro was significantly higher in the bifidobacteria intake group.
Plaque index after intake period was significantly lower in the bifidobacteria intake group.
Results date posted
| 2023 | Year | 12 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Female aged 20 to 40 years old
Participant flow
Enrollment: 30
Allocation: 30
Analysis: 30
Adverse events
There were no adverse events related to the test or placebo foods.
Outcome measures
Salivary IgA and IgA per mg of protein, oral condition, safety
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 20 | Day |
Last modified on
| 2023 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060505
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
