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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000032597 |
Receipt No. | R000037168 |
Scientific Title | A Study on the relevance between biological barrier and morbidity of infection. |
Date of disclosure of the study information | 2018/06/01 |
Last modified on | 2018/07/12 |
Basic information | ||
Public title | A Study on the relevance between biological barrier and morbidity of infection. | |
Acronym | A Study on the relevance between biological barrier and morbidity of infection. | |
Scientific Title | A Study on the relevance between biological barrier and morbidity of infection. | |
Scientific Title:Acronym | A Study on the relevance between biological barrier and morbidity of infection. | |
Region |
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Condition | |||
Condition | Healthy adults | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | The aim of this study is to reveal the effect of biological barrier on morbidity of infection |
Basic objectives2 | Others |
Basic objectives -Others | General survey to reveal the relevance between biological barrier and morbidity of infection. |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Indicators of biological barrier;
ex) activity of immune cells, body temperature, antiviral activity |
Key secondary outcomes | Questionnaire survey about lifestyle, rate of infection diseases |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
Interventions/Control_1 | |
Interventions/Control_2 | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Japanese.
Age >=20 and <=49 years. 2) Informed consent provided 3) Able to follow the instructions of the study team |
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Key exclusion criteria | 1) Serious disorder
2) Regular hospital visit and medication intended to cure 3) Women who are or may be pregnant and who are lactating 4) Subjects judged by the investigator/project leader to be ineligible for other reasons |
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Target sample size | 110 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kao Corporation | ||||||
Division name | Biological Science Research | ||||||
Zip code | |||||||
Address | 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN | ||||||
TEL | 0285-68-7769 | ||||||
mori.takuya@kao.com |
Public contact | |||||||
Name of contact person |
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Organization | Kao Corporation | ||||||
Division name | Biological Science Research | ||||||
Zip code | |||||||
Address | 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN | ||||||
TEL | 0285-68-7613 | ||||||
Homepage URL | |||||||
koga.yoshitaka@kao.com |
Sponsor | |
Institute | Kao Corporation |
Institute | |
Department |
Funding Source | |
Organization | Kao Corporation |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | University of Shizuoka |
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 | 花王株式会社(栃木県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | To reveal the effect of biological barrier on morbidity of infection |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037168 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |