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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027715
Receipt No. R000028381
Scientific Title Exploratory study of anti-microbial effects of functional food containing Mushroom-derived lectin by double-blind cross-over test
Date of disclosure of the study information 2017/06/11
Last modified on 2017/06/11

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Basic information
Public title Exploratory study of anti-microbial effects of functional food containing Mushroom-derived lectin by double-blind cross-over test
Acronym Exploratory study of anti-microbial effects of functional food containing Mushroom-derived lectin by double-blind cross-over test
Scientific Title Exploratory study of anti-microbial effects of functional food containing Mushroom-derived lectin by double-blind cross-over test
Scientific Title:Acronym Exploratory study of anti-microbial effects of functional food containing Mushroom-derived lectin by double-blind cross-over test
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 Mushroom. 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 Exploratory
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 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Rice ball containing Mushroom lectin
1 pieces / day
1week
Interventions/Control_2 Rice ball without Mushroom lectin
1 pieces / day
1week
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 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 Takashi Itou
Organization Okayama University
Division name Center for Innovative Clinical Medicine
Zip code
Address 2-5-1 Shikata-cho, Kita-ku,Okayama, Japan
TEL 086-235-6677
Email itakashi@okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Itou
Organization Okayama University
Division name Center for Innovative Clinical Medicine
Zip code
Address 2-5-1 Shikata-cho, Kita-ku,Okayama, Japan
TEL 086-235-6677
Homepage URL
Email itakashi@okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization Okayama city
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

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 岡山大学病院

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 11 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 12 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 20 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
2017 Year 06 Month 11 Day
Last modified on
2017 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028381

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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