UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062146 |
|---|---|
| Receipt number | R000071115 |
| Scientific Title | Effect of Lactic Acid Bacteria Supplementation on Exercise-Induced Intestinal Inflammation |
| Date of disclosure of the study information | 2026/07/06 |
| Last modified on | 2026/07/06 16:40:41 |
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Basic information
Public title
Effect of Lactic Acid Bacteria Supplementation on Exercise-Induced Intestinal Inflammation
Acronym
Effect of Lactic Acid Bacteria Supplementation on Exercise-Induced Intestinal Inflammation
Scientific Title
Effect of Lactic Acid Bacteria Supplementation on Exercise-Induced Intestinal Inflammation
Scientific Title:Acronym
Effect of Lactic Acid Bacteria Supplementation on Exercise-Induced Intestinal Inflammation
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of lactic acid bacteria supplementation on exercise-induced intestinal inflammation compared with a placebo supplement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intestinal inflammation index
Key secondary outcomes
Intestinal injury index
Intestinal barrier function index
Assessment of gastrointestinal symptoms
Inflammatory markers
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Four consecutive days of endurance exercise combined with a lactic acid bacteria supplement for six days starting on the first day of exercise.
Interventions/Control_2
Four consecutive days of endurance exercise combined with a placebo supplement for six days starting on the first day of exercise.
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
| 30 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male
Key inclusion criteria
1. Male subjects aged 30 to 49 years
2. Subjects who voluntarily provided written informed consent
Key exclusion criteria
1. Subjects with regular exercise habits within the past year
2. Subjects without a history of regular exercise for at least one year
3. Subjects receiving treatment for chronic diseases or with a history of serious disease
4. Subjects with musculoskeletal disorders
5. Subjects using implantable medical devices
6. Subjects with exercise restrictions
7. Subjects judged unsuitable for study participation by the study physician based on ECG results
8. Subjects with SBP >= 150 mmHg or DBP >= 100 mmHg
9. Subjects with milk or soy allergy
10. Subjects with BMI < 18.5 or >= 25.0
11. Current smokers
12. Subjects not participating in any other human studies
13. Subjects judged unsuitable for study participation by the principal investigator or study physician
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Kyosuke |
| Middle name | |
| Last name | Nakayama |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo
TEL
+81-42-632-5847
kyousuke.nakayama@meiji.com
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Yoshimura |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo
TEL
+81-42-632-5847
Homepage URL
aya.yoshimura.aa@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
CPCC Company Limited, Chiyoda Paramedical Care Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of the Chiyoda Paramedical Care Clinic
Address
2F, Daiwa Bldg.3-3-10 Nihonbashi Hongokucho, Chuo-ku, Tokyo, Japan
Tel
+81-3-6225-9005
IRB@cpcc.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
| 2026 | Year | 07 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 06 | Day |
Last modified on
| 2026 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071115
