UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058834 |
|---|---|
| Receipt number | R000067274 |
| Scientific Title | Effects of test food consumption on the intestinal environment in healthy Japanese with bowel movement concerns: an open-label study |
| Date of disclosure of the study information | 2025/08/19 |
| Last modified on | 2025/08/19 10:35:24 |
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Basic information
Public title
Effects of test food consumption on the intestinal environment in healthy Japanese with bowel movement concerns: an open-label study
Acronym
Effects of test food consumption on the intestinal environment in healthy Japanese with bowel movement concerns: an open-label study
Scientific Title
Effects of test food consumption on the intestinal environment in healthy Japanese with bowel movement concerns: an open-label study
Scientific Title:Acronym
Effects of test food consumption on the intestinal environment in healthy Japanese with bowel movement concerns
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of test food consumption on the intestinal environment in healthy Japanese.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Bifidobacteria in feces at four weeks after intervention (4w)
Key secondary outcomes
1. Putrefactive products (p-cresol, phenol, 4-ethylphenol, indole, and skatole) in feces at 4w
2. Short-chain fatty acids (acetic acid, propionic acid, succinic acid, lactic acid, iso-butyric acid, iso-valeric acid, n-butyric acid, n-valeric acid, and formic acid) in feces at 4w
3. Defecation frequency, number of defecation days, defecation volume, stool form, stool odor, and exhilarating feeling of defecation in period 2-5*
*Period 2: Days 1-7 after the start of intervention
Period 3: Days 8-14
Period 4: Days 15-21
Period 5: Days 22-28
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
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: Four weeks
Test product: Food containing bifidobacteria
Administration: Consume two packets per day after breakfast with water, without chewing.
*If you forget to consume the test product, do so as soon as you remember. Be sure to consume the daily amount within the same day and do not carry it over to the next day.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Adults
4. Healthy individuals
5. Individuals with bowel movement concerns
6. Individuals whose BMI is 18.5 kg/m2 or more and less than 23.0 kg/m2
7. Individuals whose defecation frequency is three to five times during the week before screening
Key exclusion criteria
1. Individuals who are under treatment or have a history of malignant tumor, heart failure, or myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator
3. Individuals who are under treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who consume "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. Individuals who take or use medicines (including herbal medicines) or supplements
6. Individuals who are allergic to medicines or foods related to the test product (particularly, milk, soybeans, or gelatin)
7. Individuals who have lactose intolerance
8. Individuals who are pregnant, lactating, or planning to become pregnant during this study
9. Individuals who consume foods/beverages considered to improve digestion (e.g., yogurt, lactic acid bacteria beverages, fermented foods) four or more days a week
10. Individuals who consume foods/beverages rich in dietary fiber four or more days a week
11. Individuals who consume high-protein foods/beverages (e.g., protein drinks) four or more days a week
12. Individuals who engage in intense exercise aimed at increasing muscle strength
13. Individuals who are restricting their diets or exercising for dieting
14. Individuals who drink pure alcohol an average of >= 60 g/day a week
15. Individuals who are smokers or have not yet completed one year since quitting smoking
16. Individuals who have irregular eating habits, sleep habits, or exercise habits
17. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
18. Individuals who are judged as ineligible to participate in this study by the physician
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
NAGASE BeautyCare Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
NAGASE BeautyCare 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
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 23 | 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 | 08 | Month | 19 | Day |
Last modified on
| 2025 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067274
