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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025432
Receipt No. 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 2016/12/27

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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
Email 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
Email stakashi@cc.okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

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
Email

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 Enrolling by invitation
Date of protocol fixation
2016 Year 04 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 27 Day
Last modified on
2016 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025438

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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