UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045317 |
|---|---|
| Receipt number | R000051759 |
| Scientific Title | A study of immunity |
| Date of disclosure of the study information | 2021/08/31 |
| Last modified on | 2023/01/30 18:37:42 |
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Basic information
Public title
A study of immunity
Acronym
A study of immunity
Scientific Title
A study of immunity
Scientific Title:Acronym
A study of immunity
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To consider the effect of immunity and physical condition intake -polysaccharide containing food daily for 12 weeks
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mDC after 12 weeks
Key secondary outcomes
Immune index ( s-IgA, interleukin, interferon, natural killer cell ) and symptoms score after 12 weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Intake of polysaccharide-containing food daily for 12 weeks
Interventions/Control_2
Intake of placebo food daily for 12 weeks
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
Healthy males and females from 20 to 65 years of age
Key exclusion criteria
(1) Subjects who were unaware of cold or cold-like symptoms
(2) Subjects who are taking drugs or quasi-drugs, supplements
(3) Subjects who have a history of the allergic disease
(4) Subjects who have under treatment or a history of serious disease
(5) Subjects who have oral or dental problems
(6) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(7) Subjects who are engaged in day / night shift work or midnight work, etc.
(8) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(9) Subjects who intend to become pregnant or lactating
(10) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(11) Subjects who are judged as unsuitable for the study by the investigator
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Izumi |
Organization
Shionogi Healthcare Co., Ltd.
Division name
Product Assurance Division
Zip code
540-0041
Address
6-18, Kitahama 2-chome Chuo-ku, Osaka-shi, Osakafu
TEL
06-6202-2728
hiroto.izumi@shionogi.co.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Yoshimura |
Organization
EP Mediate Co., Ltd.
Division name
Development Business Headquarters, TTC Center, Trial Planning Department
Zip code
162-0822
Address
2-23, Shimomiyabi-cho, Shinjuku-ku, Tokyo
TEL
03-5657-4983
Homepage URL
yoshimura.kaori265@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Shionogi Healthcare 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
080-2290-2544
makabe.akio295@eps.co.jp
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
| 2021 | Year | 08 | Month | 31 | 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
| 2021 | Year | 08 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 31 | Day |
Last modified on
| 2023 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051759
