UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025432 |
|---|---|
| Receipt number | R000025438 |
| Scientific Title | Exploratory study of anti-microbial effects of functional food containing Codium fragile-derived lectin by double-blind cross-over test |
| Date of disclosure of the study information | 2016/12/27 |
| Last modified on | 2021/10/19 13:58:18 |
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Basic information
Public title
Exploratory study of anti-microbial effects of functional food containing Codium fragile-derived lectin by double-blind cross-over test
Acronym
Anti-microbial effects of functional food containing Codium fragile-derived lectin
Scientific Title
Exploratory study of anti-microbial effects of functional food containing Codium fragile-derived lectin by double-blind cross-over test
Scientific Title:Acronym
Anti-microbial effects of functional food containing Codium fragile-derived lectin
Region
| Japan |
Condition
Condition
health
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the present study, we are considering the application of the lectin (protein with binding activity to the sugar chain) in the development of functional food and oral care products for the purpose of prevention of oral cavity infection. From our previous study, a kind Gal beta 1-3GalNAc-recognition lectin was found to suppress the initial adhesion and biofilm (plaque / plaque) formation by a cariogenic Streptococcus mutans through the saliva (patent #5558362). This lectin is derived from seaweed Codium fragile. To examine the safety and effectiveness of the oral care products (food) including this lectin as an ingredient, a double-blind clinical trial is planned.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reduction of bacterial ATP activity on tooth surface after 7 days
Key secondary outcomes
After 7 days;
1. Tooth surface covered by biofilm (judged from photo)
2. Gingival index of inflammation (judged from photo)
3. Sensual test (questionnaire)
4. Daly brushing
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Lectinoral Tablet
2 tablets/day
1 week
Interventions/Control_2
Orabarrier
2 tablets/day
1 week
Interventions/Control_3
Lectinoral Dental Gel
1 cotton bud / day
1 week
Interventions/Control_4
Gel without Lectinoral Dental Gel
1 cotton bud / day
1 week
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 subjects with informed consent
Key exclusion criteria
1. Allergic for these test samples
2. Pregnant women or lactation
3. Others; not applicable for study schedule and dental condition
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shogo Takashiba |
Organization
Okayama University
Division name
Department of pathophysiology - Periodontal Science, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
Address
2-5-1 Shikata-cho, Kita-ku,Okayama, Japan
TEL
086-235-6675
stakashi@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shogo Takashiba |
Organization
Okayama University
Division name
Department of pathophysiology - Periodontal Science, Graduate School of Medicine, Dentistry and Phar
Zip code
Address
2-5-1 Shikata-cho, Kita-ku,Okayama, Japan
TEL
086-235-6675
Homepage URL
stakashi@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cancelled due to unpredictable supply of the test preparation
Management information
Registered date
| 2016 | Year | 12 | Month | 27 | Day |
Last modified on
| 2021 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025438
