UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045531 |
|---|---|
| Receipt number | R000051985 |
| Scientific Title | A randomized, placebo-controlled, double-blind, parallel-group comparison study for the effects of lactic acid bacteria on the immune function in healthy Japanese adult |
| Date of disclosure of the study information | 2021/09/21 |
| Last modified on | 2025/01/31 16:27:09 |
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Basic information
Public title
A randomized, placebo-controlled, double-blind, parallel-group comparison study for the effects of lactic acid bacteria on the immune function in healthy Japanese adult
Acronym
A randomized, placebo-controlled, double-blind, parallel-group comparison study for the effects of lactic acid bacteria on the immune function in healthy Japanese adult
Scientific Title
A randomized, placebo-controlled, double-blind, parallel-group comparison study for the effects of lactic acid bacteria on the immune function in healthy Japanese adult
Scientific Title:Acronym
A randomized, placebo-controlled, double-blind, parallel-group comparison study for the effects of lactic acid bacteria on the immune function in healthy Japanese adult
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratory assess the effects of consumption of lactic acid bacteria on the immune function in healthy Japanese adult
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The immune indicator (cell surface marker, neutrophil phagocytosis, neutrophil sterilizing function, NK cell activity, and cytokines)
Key secondary outcomes
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
The consumption of lactic acid bacteria powder for four weeks
Interventions/Control_2
The consumption of placebo powder for four 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
Subjects aged 20 or more and less than 65
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a serious medical history of any disease such as malignant tumor, respiratory disease, liver, kidney, heart, lung, digestive organ, blood, endocrine system, or metabolic system
2. Subjects who have drug allergy and/or serious food allergy, or have medical history of them
3. Subjects who are pregnant, breast-feeding, and planning to become pregnant
4. Subjects who have autoimmune disease
5. Subjects who have used drugs which may influence immune function (including antiallergic drugs and antibiotics) at the period of screening, or take food containing specific bacteria such as bifidobacterium and lactic acid bacteria in daily
6. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
7. Subjects who have been taken 400 mL and more blood within 12 weeks before consumption of the test food, or 200 mL and more blood at the period of screening
8. Subjects who plan to receive vaccination for infectious diseases such as influenza or COVID-19 from after agreement to participate to the end of this trial
9. Subjects who are judged as ineligible to participate in the study based on the evaluation of the physician for any results such as participant' background, physical finding, consultation, physical examination, and clinical examination
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
MORINAGA MILK INDUSTRY CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
IRB@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 21 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2072-6643/16/2/216
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2072-6643/16/2/216
Number of participants that the trial has enrolled
100
Results
A significant difference was observed in the primary outcome due to the intake of Lactobacillus paracasei MCC1849.
Results date posted
| 2025 | Year | 01 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Refer to the paper
Participant flow
Refer to the paper
Adverse events
Refer to the paper
Outcome measures
Refer to the paper
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 10 | 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 | 09 | Month | 21 | Day |
Last modified on
| 2025 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051985
