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Recruitment status Completed
Unique ID issued by UMIN UMIN000011607
Receipt No. R000013579
Scientific Title The study of oral fungal inhibition by the sea cucumber processed food.
Date of disclosure of the study information 2013/08/31
Last modified on 2013/08/30

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Basic information
Public title The study of oral fungal inhibition by the sea cucumber processed food.
Acronym Effects of sea cucumber to oral candida
Scientific Title The study of oral fungal inhibition by the sea cucumber processed food.
Scientific Title:Acronym Effects of sea cucumber to oral candida
Region
Japan

Condition
Condition Oral candidiasis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of the anti-candida effects of the sea cucumber processed food on Candida in the oral cavity of elderly requiring nursing.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The number of Candida on the tongue and buccal mucosa.
Samplings for determine baseline are done two times during one week before starting intervention. Samplings for determined the results are done two times during one week after intervention.
Key secondary outcomes

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 Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Each participant eat one sea cucumber processed food every meal as a desert for one week (total 21 deserts).
One desert contains 3 g of sea cucumber (fresh weight).
Interventions/Control_2 Control group also eat desert without sea cucumber for one week.
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
72 years-old <=
Age-upper limit
102 years-old >=
Gender Male and Female
Key inclusion criteria Candida is stably detected from oral cavity.
Health condition is stable.
Taking every diet from mouth.
Key exclusion criteria Can not detect Candida from mouth.
Instability of health condition.
Can not eat diet.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Yano
Organization Iwate Biotechnology Research Center
Division name Research Department of Biological Resources
Zip code
Address 22-174-4 Narita, Kitakami, Iwate
TEL 0197-68-2911
Email akiray@ibrc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Yano
Organization Iwate Biotechnology Research Center
Division name Research Department of Biological Resources
Zip code
Address 22-174-4 Narita, Kitakami, Iwate
TEL 0197-68-2911
Homepage URL
Email akiray@ibrc.or.jp

Sponsor
Institute Iwate Medical University School of Dentistry
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 Japan Science and Technology Agency
Organization
Division
Category of Funding 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

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2012 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 01 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
2013 Year 08 Month 30 Day
Last modified on
2013 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013579


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