UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015140 |
|---|---|
| Receipt number | R000017402 |
| Scientific Title | The clinical study for the effect of lactoferrin and lactoperoxidase-containing food on oral malodor |
| Date of disclosure of the study information | 2014/09/16 |
| Last modified on | 2015/10/13 17:19:47 |
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Basic information
Public title
The clinical study for the effect of lactoferrin and lactoperoxidase-containing food on oral malodor
Acronym
The clinical study for the effect of lactoferrin and lactoperoxidase-containing food on oral malodor
Scientific Title
The clinical study for the effect of lactoferrin and lactoperoxidase-containing food on oral malodor
Scientific Title:Acronym
The clinical study for the effect of lactoferrin and lactoperoxidase-containing food on oral malodor
Region
| Japan |
Condition
Condition
Oral malodor
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of lactoferrin and lactoperoxidase-containing food on oral malodor
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Concentration of volatile sulfur compounds in oral air
Key secondary outcomes
Concentrations of hydrogen sulfide and methyl mercaptan in oral air
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
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of lactoferrin and lactoperoxidase-containing food
>Washout period (1 week)
Single ingestion of placebo food
Interventions/Control_2
Single ingestion of placebo food
>Washout period (1 week)
Single ingestion of lactoferrin and lactoperoxidase-containing food
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subjects aged 20-65 years
2) Subjects who have volatile sulfur compounds in mouth air above the olfactory threshold (hydrogen sulfide >1.5 ng and methyl mercaptan >0.5 ng/10 ml air)
Key exclusion criteria
1) Subjects who have severe disease of liver, kidney, heart, lung, gastro-intestine, blood, endocrine system, metabolic system etc.
2) Subjects who are receiving treatment of dental disease such as caries and periodontal disease
3) Subjects who received treatment with antibiotics in the past 1 month
4) Subjects who participated in other clinical studies in the past 1 month
5) Subjects with a history of allergy to milk or dairy products
6) Subjects who are pregnant or under lactation, or ones who would be expected to be pregnant during the study
7) Subjects judged inappropriate for the study by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiju Shimizu |
Organization
Shimizu dental clinic
Division name
Dentistry
Zip code
Address
1066 Kamikobanamachi, Takasaki City, Gunma, Japan
TEL
027-344-1177
eshimizu-umin@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiju Shimizu |
Organization
Shimizu dental clinic
Division name
Dentistry
Zip code
Address
1066 Kamikobanamachi, Takasaki City, Gunma, Japan
TEL
027-344-1177
Homepage URL
eshimizu-umin@umin.ac.jp
Sponsor or person
Institute
Shimizu dental clinic
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
清水歯科医院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 16 | 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 | 09 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 23 | Day |
Date of closure to data entry
| 2015 | Year | 06 | Month | 12 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 19 | Day |
Date analysis concluded
| 2015 | Year | 07 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 12 | Day |
Last modified on
| 2015 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017402
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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