UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058633 |
|---|---|
| Receipt number | R000067048 |
| Scientific Title | Verification study of the effect of test food intake on gastrointestinal symptoms |
| Date of disclosure of the study information | 2025/07/29 |
| Last modified on | 2025/07/29 13:50:21 |
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Basic information
Public title
Verification study of the effect of test food intake on gastrointestinal symptoms
Acronym
Verification study of the effect of test food intake on gastrointestinal symptoms
Scientific Title
Verification study of the effect of test food intake on gastrointestinal symptoms
Scientific Title:Acronym
Verification study of the effect of test food intake on gastrointestinal symptoms
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine whether foods containing lactic acid bacteria are actually effective for improving the intestinal environment in healthy adult men and women who are concerned about their stomach (gastrointestinal) condition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fecal bacterial flora, bowel movements (frequency of bowel movements, stool characteristics, etc.) based on stomach conditions questionnaires
Key secondary outcomes
Mood and lifestyle questionnaire
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake 2 tablets once a day with water or lukewarm water for 8 weeks.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Persons who are male or female and aged 18 to 74
2. Persons who are not suffering from any illness related to the stomach or intestines (have not been diagnosed with any illness) and are concerned about their stomach (stomach or intestines) but have been determined not to require immediate treatment
3. Persons who fully understand the purpose and content of the study and voluntarily agree to participate in the study
Key exclusion criteria
1. Persons who may experience stomach pain when eating foods containing lactobacillus products such as lactobacillus (FM8 strain)
2. Persons who have been diagnosed with a digestive disease, previously undergone digestive surgery, and will require digestive surgery in the future
3. Persons who regularly use lactobacillus products such as lactobacillus (FM8 strain) (3 days or more per week) and those who have regularly used lactobacillus products within the 3 months prior to the pre-test.
4. Persons who have been diagnosed with malignant tumors, currently receiving treatment for cranial nerve, heart, kidney, diabetes, or thyroid dysfunction, and with a history of serious illnesses such as liver disease, excluding illnesses like hypertension, which principal investigator determined will not affect the evaluation of the research.
5. Persons who drink a large amount of alcohol (60 g or more of alcohol per day: approximately 1500 mL of beer, 540 mL of wine, 3 cups of sake, or 180 mL of double-sized whiskey)
6. Persons who are at risk of developing allergies related to the test foods
7. Persons who are deemed unsuitable as research subjects based on their responses to a background survey
8. Persons who have participated in other research during one month prior to the start of this research, or plan to participate in other research after consenting to this research.
9. Persons who are judged to be ineligible by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Asahina |
Organization
ASPAC KIGYO K.K
Division name
CEO
Zip code
104-0044
Address
11-15 Akashicho, Chuo-ku, Tokyo, JAPAN
TEL
03-6278-8890
takayuki.asahina@gmail.com
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Tochio |
Organization
BIOSIS Lab. Co., Ltd.
Division name
CEO
Zip code
470-1101
Address
Room 506, Building No. 11, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, JAPAN
TEL
090-6904-6772
Homepage URL
takumitochiobiz@gmail.com
Sponsor or person
Institute
ASPAC KIGYO K.K
Institute
Department
Personal name
Funding Source
Organization
ASPAC KIGYO K.K
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 Ethics Committee
Address
1-18-26-204 Miharadai, Nerima-ku, Tokyo
Tel
080-7385-7987
iwahori@okutoeru.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 29 | 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
| 2024 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | 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 | 29 | Day |
Last modified on
| 2025 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067048
