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Recruitment status Completed
Unique ID issued by UMIN UMIN000015140
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email eshimizu-umin@umin.ac.jp

Sponsor
Institute Shimizu dental clinic
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017402


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