UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042485 |
|---|---|
| Receipt number | R000048483 |
| Scientific Title | Examination of the effect of continuous intake of Lactic acid bacteria on immune function and health condition maintenance. |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2024/05/17 12:55:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Examination of the effect of continuous intake of Lactic acid bacteria on immune function and health condition maintenance.
Acronym
Examination of the effect of continuous intake of Lactic acid bacteria on immune function and health condition maintenance.
Scientific Title
Examination of the effect of continuous intake of Lactic acid bacteria on immune function and health condition maintenance.
Scientific Title:Acronym
Examination of the effect of continuous intake of Lactic acid bacteria on immune function and health condition maintenance.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of continuous intake of test foods for 8 weeks on immune system and health condition in male and female aged 20 to 64.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health condition questionnaire
Key secondary outcomes
NK activity, IFN-gamma, IL-12, pDC activity, saliva s-IgA
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
Take 4 tablets of test foods with water once a day for 8 weeks.
Interventions/Control_2
Take 4 tablets of placebo foods with water once a day for 8 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Aged 20 to 64 years old at the time of informed consent
2. Japanese male and female
3. Those who are susceptible to upper respiratory tract infections in winter every year
4. Those who can input their own data into the electronic diary
5. Those who can obtain written consent
Key exclusion criteria
1. Those who are currently receiving any types of medicines and/or Chinese medical treatment (except for the drugs taken as needed)
2. Those who are on diet and exercise therapy under the supervision of a doctor
3. Those who have or had a severe disease
4. Persons with atopic dermatitis, allergic rhinitis (perennial / seasonal), bronchial asthma, chronic bronchitis
5. Those who are currently using quasi-drugs, foods for specified health use, health foods and supplements and cannot stop during the test period after obtaining consent
6. Those who regularly use foods containing lactic acid bacteria and bifidobacteria
7. Those who have been vaccinated with influenza vaccine after October 2020, or those who are planning to be vaccinated during the test period
8. Those who have a current or previous history of drug and/or food allergies
9. Those who work in shifts, or night shifts
10. Those who plan to travel abroad, such as traveling abroad, during the test period
11. Those who are currently pregnant or breastfeeding or those who want to become pregnant during the test period
12. Those who have participated in or are currently participating in other clinical trials within one month before obtaining consent, or those who are planning to participate during the trial period
13. Those who consume alcohol excessively (alcohol equivalent 60g or more / day)
14. Those who have excessive smoking habits (21 or more cigarettes / day)
15. Those who habitually engage in strenuous exercise such as marathons
16. Those who have bleeding teeth or oral problems (stomatitis, etc.)
17. Those who are judged to be unsuitable as subjects from the subject background survey.
18. Those who were determined by the investigator to be unsuitable for participation in this clinical trial.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kimiko |
| Middle name | |
| Last name | Uchiyama |
Organization
KAMEDA SEIKA CO., LTD.
Division name
Rice Research Institute
Zip code
950-0198
Address
3-1-1 Kameda-kogyodanchi, Konan-ku, Niigata-shi, Niigata, Japan
TEL
025-382-8879
k_uchiyama@sk.kameda.co.jp
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
KAMEDA SEIKA 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.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
| 2022 | Year | 04 | Month | 01 | 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
59
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
| 2020 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 17 | Day |
Last modified on
| 2024 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048483
