UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015706 |
|---|---|
| Receipt number | R000018097 |
| Scientific Title | Effect of lactoferrin and lactoperoxidase-containing food on oral hygiene status of elderly people |
| Date of disclosure of the study information | 2014/11/17 |
| Last modified on | 2015/10/23 09:15:17 |
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Basic information
Public title
Effect of lactoferrin and lactoperoxidase-containing food on oral hygiene status of elderly people
Acronym
Effect of lactoferrin and lactoperoxidase-containing food on oral hygiene status of elderly people
Scientific Title
Effect of lactoferrin and lactoperoxidase-containing food on oral hygiene status of elderly people
Scientific Title:Acronym
Effect of lactoferrin and lactoperoxidase-containing food on oral hygiene status of elderly people
Region
| Japan |
Condition
Condition
Oral hygiene
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of lactoferrin and lactoperoxidase-containing food on oral hygiene status
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Oral hygiene status
Key secondary outcomes
- The number of candida, periodontopathic bacteria, opportunistic bacteria and total bacteria in tongue coating and supragingival plaque
- Experience effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of lactoferrin and lactoperoxidase-containing food for 8 weeks
Interventions/Control_2
Ingestion of placebo food for 8 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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Subjects aged over 65 years
2) Subjects have tongue coating
Key exclusion criteria
1) Subjects who eat pureed or finely-chopped meal
2) Subjects whose nutrition has come from enteral feeding
3) Subjects who receive treatment of dental disease (except adjustment of denture, oral hygiene instruction)
4) Subjects with a history of allergy to milk
5) Subjects who had treatment with antibiotics in the past 1 month, or ones who are expected to have treatment with antibiotics
6) Subjects who consume food or oral care products which are used for preventing oral malodor or improving oral hygiene
7) Subjects who consume regularly lactoferrin or lactoperoxidase-containing food or oral care products
8) Subjects who have exacerbated disease of liver, kidney, heart, lung, gastro-intestine, blood, endocrine system, metabolic system
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shouji Hironaka |
Organization
Showa University, School of Dentistry
Division name
Department of Special Needs Dentistry, Division of Hygiene and Oral Health
Zip code
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
03-3784-8172
koeisei@dent.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takafumi Ooka |
Organization
Showa University, School of Dentistry
Division name
Department of Special Needs Dentistry, Division of Hygiene and Oral Health
Zip code
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
03-3784-8172
Homepage URL
koeisei@dent.showa-u.ac.jp
Sponsor or person
Institute
Showa University, School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
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
清徳苑（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 17 | 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
Completed
Date of protocol fixation
| 2014 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 18 | 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
| 2014 | Year | 11 | Month | 17 | Day |
Last modified on
| 2015 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018097
