UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045856 |
|---|---|
| Receipt number | R000052315 |
| Scientific Title | Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy in lactic acid bacteria on maintaining physical condition |
| Date of disclosure of the study information | 2021/10/29 |
| Last modified on | 2025/01/30 14:22:39 |
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Basic information
Public title
Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy in lactic acid bacteria on maintaining physical condition
Acronym
Clinical study to evaluate the efficacy in lactic acid bacteria on maintaining physical condition
Scientific Title
Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy in lactic acid bacteria on maintaining physical condition
Scientific Title:Acronym
Clinical study to evaluate the efficacy in lactic acid bacteria on maintaining physical condition
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effect of lactic acid bacteria on maintaining physical condition among healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective symptoms of physical conditions
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
Intake of powdered lactic acid bacteria for 24 weeks
Interventions/Control_2
Intake of powdered placebo for 24 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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subjects of both sexes aged 20 years older and younger than 75 years.
Key exclusion criteria
1) Subjects who have disease or serious medical history in liver, kidney, heart, lung, gastrointestinal tract, blood, endocrine system, or metabolism, etc.
2) Subjects who regularly use oral or nasal medications
3) Subjects with serious medication allergy, food allergy, or history of these
4) Subjects with severe perennial or seasonal allergic symptoms
5) Subjects who are scheduled to be vaccinated against COVID-19 from two weeks before the start of this study to the end of this study
6) Subjects who are pregnant, under lactation or expecting to be pregnant during this study
7) Subjects who participated in other study within 1 month prior to obtaining informed consent
8) Any candidates considered to be inappropriate for this study by the principal investigator based on their background, physical examination, etc.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | |
| Last name | Tanaka |
Organization
Morinaga Milk Industry Co., Ltd.
Division name
Food Ingredients & Technology Institute, R&D Division
Zip code
252-8583
Address
5-1-83, Higashihara, Zama-City, Kanagawa-Pref.
TEL
046-252-3070
m_tanaka@morinagamilk.co.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Nakamura |
Organization
Yamaguchi Health Lab
Division name
General manager
Zip code
754-0041
Address
MEDIFIT LAB 3F, 1-2, Ogori Reiwa, Yamaguchi-City, Yamaguchi-Pref.
TEL
083-976-4095
Homepage URL
nakamura@yamaguchi-hl.com
Sponsor or person
Institute
Morinaga Milk Industry Co., Ltd., Food Ingredients & Technology Institute, R&D Division
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Conference of Clinical Research
Address
13-23, 1-Chome, Minami Ikebukuro, Toyoshima-ku, Tokyo
Tel
03-6868-7022
jccr-info@jccr.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 | 10 | Month | 29 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2072-6643/15/15/3450
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2072-6643/15/15/3450
Number of participants that the trial has enrolled
200
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 | 30 | 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 | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | 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 | 10 | Month | 25 | Day |
Last modified on
| 2025 | 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=R000052315
