UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060701 |
|---|---|
| Receipt number | R000069433 |
| Scientific Title | Investigation of the effects of the lactic acid bacteria on the regulation of intestinal function -A Randomized, Double-Blind, Placebo-Controlled, Crossover Study- |
| Date of disclosure of the study information | 2026/02/23 |
| Last modified on | 2026/02/18 10:09:48 |
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Basic information
Public title
Investigation of the effects of the lactic acid bacteria on the regulation of intestinal function
Acronym
Investigation of the effects of the lactic acid bacteria on the regulation of intestinal function
Scientific Title
Investigation of the effects of the lactic acid bacteria on the regulation of intestinal function -A Randomized, Double-Blind, Placebo-Controlled, Crossover Study-
Scientific Title:Acronym
Investigation of the effects of the lactic acid bacteria on the regulation of intestinal function -A Randomized, Double-Blind, Placebo-Controlled, Crossover Study-
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigation the effect of test foods on the regulation of intestinal function in healthy Japanese subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of bowel function (intestinal flora, fecal organic acids, fecal putrefactive products)
Key secondary outcomes
-Evaluation of bowel function (defecation questionnaire (defecation frequency, number of defecation days, fecal output, stool consistency, stool color, stool color, post-defecation-feeling))
-Safety evaluation (blood biochemistry, hematology, adverse events)
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test foods (1 capsule per day) for 4 weeks
Interventions/Control_2
Intake of placebo food (1 capsule per day) for 4 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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy adult males and females between 18 to 65 years
(2) BMI: less than 30 kg/m2
(3) Subjects who have a tendency toward constipation
(4) Subjects who have received sufficient explanation about the purpose and content of the examination, have the ability to consent, have a good understanding, volunteered to participate and agreed to participate in the examination in writing
Key exclusion criteria
1. Subjects who were diagnosed with liver, kidney, gastrointestinal, heart, diabetes, or other diseases that may affect the results of this study, or who have a history of surgery
2. Subjects with a disease currently under treatment
3. Subjects who detect abnormal values by blood test
4. Subjects who determine ineligible by principal investigator
5. Subjects with drug or food allergies
6. Subjects who play high intensity sports and/or are on a diet
7. Subjects who can't stop using supplement, functional foods (including Food for Specified Health Uses or Foods with Function Claims), and/or Specified quasi-drugs during the current study periods
8. Subjects who are unable to stop taking "products that clearly state that lactic acid bacteria are an ingredient," excluding the test food of this study, from the time of obtaining consent, or who plan to take such products during the study period (this refers to products that clearly state that lactic acid bacteria are an ingredient, excluding those that are included in foods as a result of the manufacturing process.)
9. Subjects who are under treatment with medications
10. Those who have taken medicines that may affect the study within one month prior to the pre-test, or those who plan to take such medicines during the study period
11. Subjects who drink excessive alcohol, or who can't stop drinking from one day before each measurement
12. Subjects with smoking habit
13. Subjects with irregular life patterns and lifestyle of reversal of day and night
14. Subjects who have a habit of excessive eating and drinking
15. Subject who has been pregnant or subject who have a plan to become pregnant or breast feed during the study period
16. Subjects who is participating in the other study or planning to participate during the study period
17. Subjects who has taken the blood sampling more than 200 mL within 1 month, or plan the blood sampling during the study period
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Nakano |
Organization
Kagoshima Immaculate Heart University
Division name
Department of Nursing and Nutrition
Zip code
895-0011
Address
2365 Amatatsu-Cho, Satsuma-Sendai-City Kagoshima 895-0011, Japan
TEL
0996-23-5311
nakano@k-jundai.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Nakano |
Organization
Kagoshima Immaculate Heart University
Division name
Department of Nursing and Nutrition
Zip code
895-0011
Address
2365 Amatatsu-Cho, Satsuma-Sendai-City Kagoshima 895-0011, Japan
TEL
0996-23-5311
Homepage URL
nakano@k-jundai.jp
Sponsor or person
Institute
Kagoshima Immaculate Heart University
Institute
Department
Personal name
Funding Source
Organization
MINAMI NIHON RAKUNO KYODO 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
Kagoshima Immaculate Heart University IRB
Address
2365 Amatatsu-Cho, Satsuma-Sendai-City Kagoshima 895-0011, Japan
Tel
0996-23-5311
nakano@k-jundai.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 | 02 | Month | 23 | 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
| 2025 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | 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 | 02 | Month | 18 | Day |
Last modified on
| 2026 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069433
