UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053946 |
|---|---|
| Receipt number | R000061572 |
| Scientific Title | Investigation of the effects of lactic acid bacteria-containing food intake on the intestinal environment |
| Date of disclosure of the study information | 2024/03/22 |
| Last modified on | 2025/09/18 20:17:00 |
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Basic information
Public title
Investigation of the effects of lactic acid bacteria-containing food intake on the intestinal environment
Acronym
Investigation of the effects of lactic acid bacteria-containing food intake on the intestinal environment
Scientific Title
Investigation of the effects of lactic acid bacteria-containing food intake on the intestinal environment
Scientific Title:Acronym
Investigation of the effects of lactic acid bacteria-containing food intake on the intestinal environment
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effect of lactic acid bacteria (LAB) -containing food on the tendency to defecate and the intestinal environment for people prone to constipation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation frequency
Key secondary outcomes
1. Defecation status (frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, odor)
2. Gut microbiota
3. Gut metabolomes
4. Abdominal symptoms (bloating, belching, gas) at times other than during 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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of test food 1 (2 capsules per day for 8 weeks)
Interventions/Control_2
Consumption of test food 2 (2 capsules per day for 8 weeks)
Interventions/Control_3
Consumption of Placebo food (2 capsules per day for 8 weeks)
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
1. At informed consent, male/female subjects aged more than or equal to 20, and less than 65 years old.
2. Defecation frequency is between 3 and 5 times a week.
3. Subjects who can show their understanding of the study procedure and agreement with participating in the study by informed consent prior to the study.
Key exclusion criteria
1. Subjects who have consumed products containing LAB (refers to those clearly indicated as ingredients, excluding those contained in the food as a result of the manufacturing process) for one month prior to the start of intervention, or those who plan to consume such products during the study.
2. Subjects who are unable to discontinue consumption of foods for specified health uses, foods with function claims, health foods (including supplements) that may affect the study (intestinal regulation, etc.) from the time consent is obtained.
3. Subjects who have taken drugs (antibiotics, antiflatulent, laxatives, etc.) that would affect the study one month prior to the pre-test, or during the study.
4. Subjects with a history of appendectomy.
5. Subjects who have undergone surgery that may affect the study (colonoscopy, removal of gallstones or gall bladder, gastric bypass surgery, bariatric surgery, etc.) within 6 months prior to obtaining consent.
6. Subjects who are expected to undergo a major change in their family, work, or other living environment (e.g., relocation, transfer, etc.) during the study.
7. Subjects with extremely irregular eating habits.
8. Subjects whose roommates plan to participate in the study.
9. Smokers.
10. Heavy alcohol drinkers.
11. Subjects with a history of serious diseases of the heart, liver, kidneys, digestive organs, etc.
12. Pregnant, lactating, or intending to become pregnant during the study.
13. Subjects allergic to medicines and foods.
(Due to character limitation, the following will be listed in the "Others" section)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Murakami |
Organization
Metagen, Inc.
Division name
Headquarters
Zip code
997-0052
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
+81-235-64-0330
research@metagen.co.jp
Public contact
Name of contact person
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Division
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongokucho, Chuo-ku, Tokyo, Japan
TEL
+81-3-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
Metagen, Inc.
Institute
Department
Personal name
Funding Source
Organization
ITO EN, 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongokucho, Chuo-ku, Tokyo 103-0021, 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
| 2024 | Year | 03 | Month | 22 | 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
30
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
Completed
Date of protocol fixation
| 2024 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Continuing from exclusion criteria)
14. Participating in a clinical study of another drug or health food, within 4 weeks of the completion of the study, or who is scheduled to participate in another clinical study after consent to participate in this study.
15. Subjects who have donated 200 mL of blood in one month before start of the study.
16. Males who have donated 400 mL of blood within 3 months before start of the study.
17. Females who have donated 400 mL of blood within 4 months before start of the study.
18. Males whose blood collected in the 12 months before study plus the expected blood for the study exceeds 1200 mL.
19. Females whose blood collected in the 12 months before study plus the expected blood for the study exceeds 800 mL.
20. Those who are judged by the principal investigator or sub-investigator to be inappropriate to participate in this study.
Management information
Registered date
| 2024 | Year | 03 | Month | 22 | Day |
Last modified on
| 2025 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061572
