UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046586 |
|---|---|
| Receipt number | R000053041 |
| Scientific Title | A preliminary study on the effect of a lactic acid bacteria intake on immune function. -a open-label, single-arm trial- |
| Date of disclosure of the study information | 2022/01/19 |
| Last modified on | 2022/08/09 11:12:04 |
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Basic information
Public title
A preliminary study on the effect of a lactic acid bacteria intake on immune function. -a open-label, single-arm trial-
Acronym
A preliminary study on the effect of a lactic acid bacteria intake on immune function
Scientific Title
A preliminary study on the effect of a lactic acid bacteria intake on immune function. -a open-label, single-arm trial-
Scientific Title:Acronym
A preliminary study on the effect of a lactic acid bacteria intake on immune function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effect of continuous intake of a hard capsule containing killed lactic acid bacteria powder for 8 weeks on immune function in healthy males and females aged between 40 and less than 65 years old.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Immune function-related markers
Questionnaire for physical health
Questionnaire for fatigue assessment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take one capsule of the test food with water or warm water within 30 min after dinner once a day.
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Aged between 40 and less than 65 years old.
2. Japanese males and females.
3. Individuals who contract the common cold between winter and spring every year.
4. BMI between 18.5 kg/m^2 and less than 30.0 kg/m^2.
5. Individuals who can use smartphones or PCs to input an electronic diary.
6. Individuals who received sufficient explanation for the objective and summary of the trial, and voluntarily volunteered to the trial with the agreement of informed consent.
Key exclusion criteria
1. Individuals who have mouth dryness, or Sjogren's syndrome.
2. Individuals who are currently undergoing treatment for any disease.
3. Individuals who have been receiving nutritional and exercise therapy under medical doctor's management.
4. Individuals who have severe diseases or a history of severe diseases.
5. Individuals who have allergic dermatitis, allergic rhinitis, bronchial asthma, or chronic bronchitis.
6. Individuals who have currently been taking commercially available drugs, quasi-drug products, and foods, drinks, or supplements with any functional claims.
7. Individuals who have been taking yogurts, beverages, health foods, supplements which include lactic acid bacteria and/or Bifidobacterium.
8. Individuals who have a drug allergy, or a food allergy.
9. Individuals who are currently pregnant or breastfeeding, or planning to pregnant during the study period.
10. Individuals who work in shift and night shift.
11. Individuals who are planning travel to foreign countries during the study period.
12. Individuals who drink more than 60 g alcohol/day.
13. Individuals who have been vaccinated to protect against infectious diseases, such as influenza virus or SARS-CoV-2, one month before the screening period. Also, individuals who are planning vaccination during the study period.
14. Individuals who are planning extremely change their lifestyle (such as diet, sleep, or exercise) during the study period.
15. Individuals who joined other clinical trials from one month before obtaining informed consent in this study, or individuals who have currently been joined other clinical trials. Also, individuals who are planning to join other clinical trials.
16. Individuals who are unsuitable for this study, that judged by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Eriko |
| Middle name | |
| Last name | Uehara |
Organization
Sanwa Shurui Co., Ltd.
Division name
Research & Development Laboratory
Zip code
879-0495
Address
2231-1 Yamamoto, Usa, Oita,879-0495
TEL
0978-33-3844
dobashi-e@kokuzo.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Sales department
Zip code
104-0061
Address
Daiwa Ginza Bld. 3F, 6-2-1, Ginza, Chuo-ku
TEL
03-6704-5968
Homepage URL
y-hira@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Sanwa Shurui Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
n-yuzawa@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 | 01 | Month | 19 | 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
20
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 | 10 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 07 | Day |
Last modified on
| 2022 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053041
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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