UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011607 |
|---|---|
| Receipt number | 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 19:54:37 |
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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
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
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
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
akiray@ibrc.or.jp
Sponsor or person
Institute
Iwate Medical University School of Dentistry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013579
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| Registered date | File name |
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| Registered date | File name |
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