UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060960 |
|---|---|
| Receipt number | R000069756 |
| Scientific Title | Study to confirm the effect of food containing bifidobacterium intake on improving the intestinal environment. |
| Date of disclosure of the study information | 2026/03/19 |
| Last modified on | 2026/03/17 09:45:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study to confirm the effect of food containing bifidobacterium intake on improving the intestinal environment.
Acronym
Study to confirm the effect of food containing bifidobacterium intake on improving the intestinal environment.
Scientific Title
Study to confirm the effect of food containing bifidobacterium intake on improving the intestinal environment.
Scientific Title:Acronym
Study to confirm the effect of food containing bifidobacterium intake on improving the intestinal environment.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirm the effect of improving the intestinal environment when a food containing bifidobacteria is consumed continuously for 4 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Organic acids content in feces.(Acetic acid)
2)Organic acids content in feces.(Propionic acid)
3)Organic acids content in feces.(n-butyric acid)
Key secondary outcomes
Fecal analysis (Counts of Bifidobacterium, Amplicon sequencing analysis, Organic acids, Putrefactive products, Ammonia, pH, water content), NOx (nitric oxide), RLP-C, baPWV, adiponectin, Visual Analog Scale.
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily intake of a food containing bifidobacterium for 4 weeks.
Interventions/Control_2
Daily intake of placebo 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
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Healthy Japanese males and females aged 20 to 64 years,at the time of informed consent.
2)Participant with 3 to 5 bowel movements per week during the 2-week pre-observation period.
3)Participant who can visit the trial site on the scheduled visit date.
4)Participant who fully understand the purpose and content of this study and provided written consent prior to trial initiation.
Key exclusion criteria
1)Participant taking medicines/foods that affect the intestinal environment three or more times per week.
2)Participant with a history of serious liver, kidney, cardiovascular, gastrointestinal, pulmonary, blood, or metabolic disease.
3)Participant with chronic diseases and regular users of medicines.
4)Participant with a history or current history of drug or alcohol dependence.
5)Participant with a history of gastrointestinal disease or surgery that affects digestion, absorption, or defecation.
6)Participant with food allergies related to the test food.
7)Participant with extremely irregular daily habits and eating habits (including late-night workers).
8)Participant who cannot restrict the use of drugs/foods that affect the study after obtaining consent.
9)Participant with excessive exercise, alcohol consumption, or smoking habits.
10)Pregnant or lactating women or women who may become pregnant during the study period.
11)Participant who have taken antibiotics within 1 month prior to obtaining consent, or plan to take them during the study period.
12)Participant who have participated in any other clinical research within 1 month prior to obtaining consent, are currently participating, or are scheduled to participate during the study period.
13)Participant who plan to change their lifestyle drastically after obtaining consent and before the end of the study.
14)Participant who plan to travel abroad after obtaining consent and before the end of the study.
15)Participant judged to be unsuitable based on their answers to the background questionnaire.
16)Other participant who are judged by the investigator to be unsuitable for the study.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Watanabe |
Organization
MEGMILK SNOW BRAND Co., Ltd.
Division name
Milk Science Research Institute
Zip code
350-1165
Address
1-1-2, Minamidai, Kawagoe-shi, Saitama, 350-1165, Japan
TEL
049-242-8150
masayuki-watanabe@meg-snow.com
Public contact
Name of contact person
| 1st name | Misaki |
| Middle name | |
| Last name | Sakata |
Organization
APO PLUS STATION CO., LTD.
Division name
Clinical Operations Dept., CRO Business div.
Zip code
103-0027
Address
2-14-1, Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
TEL
03-6777-7789
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
MEGMILK SNOW BRAND 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
Ethics Review Committee of Watanabe Hospital
Address
1-5-16, Haneda, Otaku, Tokyo, 144-0043, Japan
Tel
03-3741-0223
food-contact@apoplus.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
医療法人社団 渡辺病院(東京都) / Watanabe Hospital
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2027 | Year | 01 | 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
| 2026 | Year | 03 | Month | 17 | Day |
Last modified on
| 2026 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069756
