UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052417 |
|---|---|
| Receipt number | R000059832 |
| Scientific Title | A study to confirm the effect of lactic acid bacteria intake on intestinal environment in healthy elderly subjects - Randomized, double-blind, placebo-controlled, parallel-group study - |
| Date of disclosure of the study information | 2025/05/31 |
| Last modified on | 2023/10/05 09:41:06 |
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Basic information
Public title
A study to confirm the effect of lactic acid bacteria intake on intestinal environment in healthy elderly subjects - Randomized, double-blind, placebo-controlled, parallel-group study -
Acronym
A study to confirm the effect of lactic acid bacteria intake on intestinal environment in healthy elderly subjects
Scientific Title
A study to confirm the effect of lactic acid bacteria intake on intestinal environment in healthy elderly subjects - Randomized, double-blind, placebo-controlled, parallel-group study -
Scientific Title:Acronym
A study to confirm the effect of lactic acid bacteria intake on intestinal environment in healthy elderly subjects
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify comprehensively the effects of lactic acid bacteria on intestinal environment in healthy elderly subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fecal metabolites
Key secondary outcomes
Gut microbiome
Oral microbiome
Fecal concentration of organic acids
Fecal concentration of putrefaction products
Fecal concentration of ammonia
Salivary stress markers
OSA sleep inventory MA version
Questionnaires on skin
Skindex-16
POMS2 (Short Form)
Fecal amount, days of defecation, frequency of defecation, BSS, fecal color, fecal odor, feeling after defecation
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
8-week intake of lactic acid bacteria
Interventions/Control_2
8-week intake of placebo (not containing lactic acid bacteria)
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese males and females ages 60 and over
2. Subjects who are able to collect and send specimens by the specified method during the specified period
3. Subjects whose defecation frequency is more than three times per week
4. Subjects who have received sufficient explanation of the purpose and content of the study, have the capacity to consent, have voluntarily volunteered to participate based on a good understanding of the study, and have agreed to participate in the study in writing
Key exclusion criteria
Subjects-
1. suffering from serious liver, kidney, heart, respiratory, endocrine, metabolic, or immunodeficiency diseases
2. who take medication for diabetes
3. with a history or current history of drug or alcohol dependence
4. who consistently consumes more than the appropriate amount of alcohol (approximately 40 g of pure alcohol per day)
5. with extremely irregular eating habits
6. with recurring constipation or diarrhea
7. who cannot comply with restrictions on foods and supplements that affect the intestinal environment during the research period
8. who have taken antibiotics or antibacterial agents within 1 month before taking test foods.
9. who have a history of serious gastrointestinal disease surgeries
10. who have some allergies to the components of the test food products
11. who smoke
12. who have oral problems that involve bleeding, or plan to undergo dental or oral treatment
13. who are diagnosed with dry mouth
14. who are currently participating in other clinical studies that take or apply other foods, pharmaceuticals, cosmetics, or chemicals, who have participated in other clinical studies within the past three months from the date of consent, or who plan to participate in others
15. who are determined to be inappropriate as research subjects by the principal investigator--
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Tsuge |
Organization
Shinagawa Season Terrace Health Care Clinic
Division name
Doctor
Zip code
108-0075
Address
1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
TEL
03-3452-3382
shibaura@sempos.or.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numazu |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gunma
Tel
027-212-5608
sagawa@mc-connect.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
| 2025 | Year | 05 | Month | 31 | 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
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 09 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 05 | Day |
Last modified on
| 2023 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059832
