UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053892 |
|---|---|
| Receipt number | R000061466 |
| Scientific Title | Evaluation of the impact of foods containing probiotics from a person's gut microbiota on that their gut microbiota |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/09/17 12:59:05 |
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Basic information
Public title
Evaluation of the impact of foods containing probiotics from a person's gut microbiota on that their gut microbiota
Acronym
Evaluation of the impact of foods containing probiotics from a person's gut microbiota on that their gut microbiota
Scientific Title
Evaluation of the impact of foods containing probiotics from a person's gut microbiota on that their gut microbiota
Scientific Title:Acronym
Evaluation of the impact of foods containing probiotics from a person's gut microbiota on that their gut microbiota
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the impact of foods containing probiotics from a person's gut microbiota on that their gut microbiota
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relative abundance of Bifidobacterium
Key secondary outcomes
Gut microbiota analysis
Subjective evaluation questionnaire on depression, activity levels, and sleep quality
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake test food for 1week > follow up for 3 weeks
Interventions/Control_2
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Male and female participants aged 20 to under 60 years at the time of consent acquisition.
2. Individuals who have received sufficient explanation about the trial, can understand its content, and from whom consent has been obtained personally.
Key exclusion criteria
1. Individuals who regularly use specific health foods, functional foods, health supplements, supplements, probiotics, etc., more than three times a week, which could potentially affect the trial, and cannot discontinue them from the time of consent acquisition.
2. Individuals who have taken medications (e.g., antibiotics, intestinal regulators, laxatives, etc.) that may potentially affect the trial within 3 months prior to consent acquisition.
3. Individuals deemed unsuitable as trial subjects based on the responses to the background survey in the preliminary investigation.
4. Heavy alcohol drinkers.
5. Individuals with a history or current presence of serious diseases of the heart, liver, kidneys, digestive system, etc.
6. Pregnant, breastfeeding, or individuals intending to become pregnant during the trial period.
7. Individuals with allergies to medications or food.
8. Individuals participating in other clinical trials for drugs or health foods, within 4 weeks after the end of such trials, or planning to participate in another clinical trial after consenting to participate in this trial.
9. Individuals whom the trial investigator deems inappropriate for participation in the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Natsuki |
| Middle name | |
| Last name | Suganuma |
Organization
bacterico
Division name
Research and Development Department
Zip code
530-0027
Address
7th Floor, Sankyo Umeda Building, 1-5 Douyamacho, Kita-ku, Osaka City, Osaka Prefecture
TEL
06-4397-3516
info@bacterico.co.jp
Public contact
Name of contact person
| 1st name | Natsuki |
| Middle name | |
| Last name | Suganuma |
Organization
bacterico
Division name
Research and Development Department
Zip code
530-0027
Address
7th Floor, Sankyo Umeda Building, 1-5 Douyamacho, Kita-ku, Osaka City, Osaka Prefecture
TEL
06-4397-3516
Homepage URL
info@bacterico.co.jp
Sponsor or person
Institute
Bacterico
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Chiyoda Paramedical Care Clinic Ethics Committee
Address
2nd Floor, Daiwa Building, 3-3-10 Nihonbashi Honcho, Chuo-ku, Tokyo
Tel
03-6225-9005
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
| 2025 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2023 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2024 | Year | 03 | Month | 18 | Day |
Last modified on
| 2025 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061466
