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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000046586
Receipt No. 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 2022/03/16

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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
Email 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
Email y-hira@imeqrd.co.jp

Sponsor
Institute IMEQRD Co., Ltd
Institute
Department

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
Email 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
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 No longer recruiting
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 03 Month 16 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053041

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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