UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058344 |
|---|---|
| Receipt number | R000066697 |
| Scientific Title | The Exploratory Study of the Effects of Continuous Intake of Foods Containing Lactic Acid Bacteria on Intestinal Regulation - A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Trial - |
| Date of disclosure of the study information | 2025/07/02 |
| Last modified on | 2026/01/05 11:30:06 |
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Basic information
Public title
The Exploratory Study of the Effects of Continuous Intake of Foods Containing Lactic Acid Bacteria on Intestinal Regulation
Acronym
The Exploratory Study of the Effects of Continuous Intake of Foods Containing Lactic Acid Bacteria on Intestinal Regulation
Scientific Title
The Exploratory Study of the Effects of Continuous Intake of Foods Containing Lactic Acid Bacteria on Intestinal Regulation
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Trial -
Scientific Title:Acronym
The Exploratory Study of the Effects of Continuous Intake of Foods Containing Lactic Acid Bacteria on Intestinal Regulation
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Trial -
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effects of a four-week continuous intake of foods containing lactic acid bacteria A or B on intestinal regulation, as compared to placebo food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation status
Key secondary outcomes
Stool test
Blood test
Questionnaire on subjective symptoms
Adverse events attributable to the study foods
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take 100 g of test food containing lactic acid bacteria A once daily at any time for four weeks.
Interventions/Control_2
Take 100 g of test food containing lactic acid bacteria B once daily at any time for four weeks.
Interventions/Control_3
Take 100 g of plcebo food once daily at any time for four weeks.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Healthy Japanese male and female aged >=20 and <65 years at the time of consent.
2.Indivisuals with an average defecation frequency of five or fewer times per week in the two months prior to consent.
3.Indivisuals with a BMI of <25.0 kg/m2.
4.Indivisuals who are able to input data into an electronic diary using a smartphone or PC.
5.Indivisuals who have received sufficient explanation regarding the purpose and content of this study, have the capacity to consent, and voluntarily agree to participate after fully understanding the information.
Key exclusion criteria
Individuals who take Foods for Specified Health Uses, Foods with Function Claims, health foods, or certain general foods that may affect the study at least three times a week, or who cannot discontinue the intake of those from the time of consent.
Individuals who have taken medications that may affect the study within one month prior to obtaining consent, or who plan to take such medications during the study period.
Individuals who plan to undergo endoscopy, gastric barium examinations, or Helicobacter pylori eradication during the study period.
Individuals who cannot refrain from alcohol from the day prior to each examination.
Individuals with a high alcohol consumption.
Individuals who smoke or have not been abstine smoke for at least six months.
Individuals with gastrointestinal diseases or with a history of gastrointestinal surgery that may affect digestion or absorption.
Individuals currently taking medication for lifestyle-related diseases or other treatments.
Individuals who are undergoing treatment at a medical institution or similar.
Individuals with an irregular lifestyle.
Individuals who plan to move with an overnight stay of three nights or more during the study period.
Individuals currently participating in clinical trials, those who plan to participate in other clinical trial within four weeks after the completion of the study or after obtaining consent to participate in the study.
Individuals who are pregnant, breastfeeding, or intend to become pregnant during the study period.
Individuals who are aware of or have been diagnosed with lactose intolerance or irritable bowel syndrome.
Individuals who are aware that they experience excessive abdominal symptoms when consuming probiotics or prebiotics.
Individuals with allergies to medications or foods.
Individuals whose donated component blood or whole blood exceeds specified limit.
Individuals who are deemed as inappropriate for participation in this study by the principal investigator or co-investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Takahashi |
Organization
Medical corporation Hirookai HigashiKoganei Sakura Clinic
Division name
Hospital director
Zip code
184-0011
Address
4-37-26 Higashicho, Koganei-shi, Tokyo
TEL
042-382-3888
clinical-trial@imeqrd.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning & Sales Department
Zip code
104-0061
Address
Daiwa Ginza Building 3F, 6-2-1 Ginza, Chuo-ku, Tokyo
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.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 | 07 | Month | 02 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 16 | 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 | 07 | Month | 02 | Day |
Last modified on
| 2026 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066697
