UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058054 |
|---|---|
| Receipt number | R000066355 |
| Scientific Title | The study of the changes in defecation information by ingestion of probiotic food |
| Date of disclosure of the study information | 2025/06/12 |
| Last modified on | 2025/06/02 16:39:07 |
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Basic information
Public title
The study of the changes in defecation information by ingestion of probiotic food
Acronym
The study of the changes in defecation information by ingestion of probiotic food
Scientific Title
The study of the changes in defecation information by ingestion of probiotic food
Scientific Title:Acronym
The study of the changes in defecation information by ingestion of probiotic food
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the changes in defecation information by constant ingestion of probiotic food
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation-related indicator
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingest of probiotic food during the 4-week intervention period
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Those whose workplace is the TOTO Research Institute on the date of consent
2.Those who have received sufficient explanation about the purpose and content of this study, have the ability to consent, fully volunteered with voluntary intention, agreed to participate
Key exclusion criteria
1.Those who regularly use medicines that affect the intestinal environment, such as Intestinal regulator, constipation medicine, laxative.
2.Those who cannot stop taking foods for specified health uses, foods with functional claims, health foods, or foods containing lactobacillus, bifidobacterium, oligosaccharides, etc. during the study period.
3.Those who have a disease of the liver, kidneys, heart, lungs, digestive system, blood, endocrine system, or metabolism, or those who have a serious medical history of such diseases.
4.Those who have a serious drug or food allergy or a history of serious allergies.
5.Those who have a milk allergy or lactose intolerance.
6.Those who are pregnant, intend to become pregnant during the study period, or are breastfeeding.
7.Those who have participated in other drug or food trials within the past month, or those who intend to participate in such trials during the study.
8.Those who are deemed unsuitable as subjects by the study physician based on the results of the subject background, etc.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Oba |
Organization
TOTO LTD. Research Institute
Division name
Life Science R&D Dept
Zip code
253-8577
Address
2-8-1, Honson, Chigasaki-City, KANAGAWA Pref., JAPAN
TEL
0467-54-3380
masayuki.oba@jp.toto.com
Public contact
Name of contact person
| 1st name | Ayano |
| Middle name | |
| Last name | Hosokawa |
Organization
TOTO LTD. Research Institute
Division name
Life Science R&D Dept
Zip code
253-8577
Address
2-8-1, Honson, Chigasaki-City, KANAGAWA Pref., JAPAN
TEL
0467-54-3387
Homepage URL
ayano.hosokawa@jp.toto.com
Sponsor or person
Institute
TOTO LTD. Research Institute
Institute
Department
Personal name
Funding Source
Organization
TOTO 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
Japan Conference of Clinical Research
Address
1-13-23 Minami-ikebukuro, Toshima-Ku, Tokyo, Japan
Tel
03-6868-7011
jccr-info@jccr.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 | 06 | Month | 12 | 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 | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 10 | 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
| 2025 | Year | 06 | Month | 02 | Day |
Last modified on
| 2025 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066355
