UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062144 |
|---|---|
| Receipt number | R000071065 |
| Scientific Title | Study on the Effects of Continued Consumption of the Test Food on the Gut Microbiota - Single Arm Open Label Trial - |
| Date of disclosure of the study information | 2026/07/14 |
| Last modified on | 2026/07/01 13:45:45 |
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Basic information
Public title
A study on the Effects of Continued Consumption of the Test Food on the Gut Microbiota
Acronym
A study on the Effects of Continued Consumption of the Test Food on the Gut Microbiota
Scientific Title
Study on the Effects of Continued Consumption of the Test Food on the Gut Microbiota
- Single Arm Open Label Trial -
Scientific Title:Acronym
Study on the Effects of Continued Consumption of the Test Food on the Gut Microbiota
- Single Arm Open Label Trial -
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of 8 weeks of continuous consumption of the test food on the gut microbiota in men and women aged 20 to under 65 years.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Short-chain fatty acids
Key secondary outcomes
Gut microbiota composition,Bowel movement assessment
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
Take 3 sachets of the test food per day (15 mL per sachet).
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Aged 20 years or older and under 65 at the time of informed consent
2.Japanese men or women
3.Able to enter electronic diaries via smartphone or PC
4.Individuals who have received a thorough explanation of the study, fully understand its purpose and procedures, voluntarily wish to participate, and provide written informed consent
Key exclusion criteria
1.Currently receiving outpatient treatment or medication (including Kampo) for any disease (as-needed use permitted)
2.Under dietary or exercise therapy supervised by a physician
3.Current or past history of serious disease
4.Used medications affecting the study (e.g., antibiotics, probiotics, laxatives) within 1 month before consent, or plans to use during the study
5.Planned endoscopy, barium examination, H. pylori eradication, or tooth extraction during the study
6.History of gastrointestinal diseases or surgeries affecting digestion/absorption (excluding appendectomy or hemorrhoid surgery)
7.Currently taking quasi-drugs, specified health foods, health foods, or supplements 3 or more days per week (those taking <=2 days/week must maintain same frequency/amount; starting new intake is prohibited)
8.Current or past history of drug or food allergies
9.Habitual excessive alcohol consumption (>=40g pure alcohol/day)
10.Habitual excessive smoking (>=21 cigarettes/day)
11.Shift workers with night shifts
12.Plans to significantly change lifestyle (diet, sleep, exercise, etc.) during the study
13.Plans for overseas travel during the study
14.Pregnant, breastfeeding, or planning pregnancy during the study
15.Participated in another clinical study within 1 month before consent, currently participating, or planning to participate during the study
16.Deemed unsuitable for participation by the principal investigator
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Kisato |
| Middle name | |
| Last name | Kusano |
Organization
AUREO Co. Ltd.
Division name
Tokyo headquarters
Zip code
105-0014
Address
2-14-5 Shiba, Minato-ku, Tokyo 105-0014, Japan
TEL
03-6634-7853
kusano-kisato@aureo.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza, Chuo-ku, Tokyo, Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
AUREO 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
| 2026 | Year | 07 | Month | 14 | 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 | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 02 | 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 | 07 | Month | 06 | Day |
Last modified on
| 2026 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071065
