UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061070 |
|---|---|
| Receipt number | R000069881 |
| Scientific Title | A study to confirm the effect of food containing lactic acid bacteria intake on bowel movements. : A randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2026/06/12 |
| Last modified on | 2026/03/26 18:01:49 |
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Basic information
Public title
A study to confirm the effect of food containing lactic acid bacteria intake on bowel movements.
Acronym
A study to confirm the effect of food containing lactic acid bacteria intake on bowel movements.
Scientific Title
A study to confirm the effect of food containing lactic acid bacteria intake on bowel movements.
: A randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
A study to confirm the effect of food containing lactic acid bacteria intake on bowel movements.
: A randomized, placebo-controlled, double-blind, parallel-group comparison study
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of continuous intake of food containing lactic acid bacteria for 4 weeks on defecation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of defecations per week
Key secondary outcomes
Defecation survey
Fecal organic acid concentrations
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
Intake of active food for 4 weeks
Interventions/Control_2
Intake of placebo food 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 males and females aged 20-64 years at the time of consent to participate in the study.
2)Individuals with 3 to 5 bowel movements per week during the run-in period.
3)Individuals who can visit the trial site on the scheduled visit dates, and who can collect and submit fecal samples within the specified period.
4)Individuals who understand the purpose and content of the study and provide online informed consent prior to participation.
Key exclusion criteria
1)Individuals who regulary take medicines/foods that affect the intestinal environment.
2)Individuals with a history of serious liver, kidney, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease.
3)Individuals with chronic diseases and who regularly use medicines.
4)Individuals with a current or history of drug or alcohol dependence.
5)Individuals with a history of gastrointestinal disease or surgery that affects digestion, absorption, or defecation.
6)Individuals with food allergies related to the test food.
7)Individuals with extremely irregular dailyand eating habits (including late-night workers).
8)Individuals who cannot restrict the use of drugs/foods that affect the study after providing informed consent.
9)Individuals with excessive exercise, drinking and smoking habits.
10)Pregnant or lactating women, or women who may become pregnant during the study period.
11)Individuals who have taken antibiotics within 1 month prior to providing informed consent or who will take antibiotics during the study period.
12)Individuals who have participated in, are currently participating in, or plan to participate in any other clinical research within 1 month prior to providing informed consent or during the study period.
13)Individuals who plan to change their lifestyle drastically after providing informed consent and before the end of the study.
14)Individuals who plan to travel abroad after providing informed consent and before the end of the study.
15)Individuals who are judged to be unsuitable based on their responses to the background questionnaire.
16)Other individuals who are judged by the investigator to be unsuitable for the study.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Uenishi |
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
h-uenishi@meg-snow.com
Public contact
Name of contact person
| 1st name | Toyotada |
| Middle name | |
| Last name | Ashino |
Organization
Trans Genic Inc.
Division name
Clinical Research Department
Zip code
061-1405
Address
452-1 Toiso,Eniwa,Hokkaido,Japan
TEL
0123-34-0412
Homepage URL
toyotada.ashino@transgenic.co.jp
Sponsor or person
Institute
MEGMILK SNOW BRAND 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
Medical Corporation Jikokai Fukuzumi Internal Medicine Clinic Clinical Trial Review Committee
Address
1-2-5 Fukuzumi-2jo, Toyohira-ku, Sapporo, Hokkaido, Japan
Tel
011-836-3531
shibata@jkkai.or.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
| 2026 | 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
| 2026 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 25 | 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 | 26 | Day |
Last modified on
| 2026 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069881
