UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061982 |
|---|---|
| Receipt number | R000070905 |
| Scientific Title | A study evaluating the effects of a gut microbiota-modulating component on the human fecal microbiota |
| Date of disclosure of the study information | 2026/06/22 |
| Last modified on | 2026/06/19 19:46:01 |
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Basic information
Public title
A study evaluating the effects of a gut microbiota-modulating component on the human fecal microbiota
Acronym
A study evaluating the effects of a gut microbiota-modulating component on the human fecal microbiota
Scientific Title
A study evaluating the effects of a gut microbiota-modulating component on the human fecal microbiota
Scientific Title:Acronym
A study evaluating the effects of a gut microbiota-modulating component on the human fecal microbiota
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effects of food components on the gut microbiota are evaluated using in vitro culture of human fecal samples.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Short-chain fatty acids
Key secondary outcomes
Intestinal microbiota
Putrefactive substances
Metabolites derived from intestinal bacteria
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy Japanese men and women aged 20 to 59 at the time of obtaining informed consent to participate in the study.
2) Individuals who have 5 to 10 bowel movements per week.
3) Individuals who received a thorough explanation of the study's purpose and content and signed the informed consent form prior to the start of the study.
4) Individuals whom the principal investigator or other designated personnel determined to be suitable for participation in the study.
Key exclusion criteria
1) Individuals currently undergoing treatment for a serious illness.
2) Individuals with chronic diarrhea or constipation.
3) Individuals who do not habitually eat three meals a day.
4) Individuals who habitually consume an average of 20 grams or more of pure alcohol per day.
5) Individuals who regularly take pharmaceuticals, quasi-drugs, or traditional Chinese medicines.
6) Individuals who regularly consume health foods.
(including foods for specified health uses, foods with nutritional functions, foods with functional claims, supplements, and other so-called health foods) that may affect the evaluation criteria
7) Individuals who are unable to refrain from consuming health foods or medications that may affect the evaluation criteria for one month prior to stool collection.
8) Individuals currently receiving medical treatment for a gastrointestinal disorder, or those with a history of gastrointestinal surgery (excluding appendectomy)
9) Individuals currently participating in a clinical trial, or who have participated in another clinical trial within the past 3 months prior to the date of informed consent.
10) Individuals who cannot maintain their usual lifestyle habits from the preliminary examination through the main examination.
11) Individuals who are menstruating at the time of the main examination, or who may be menstruating.
12) Individuals who are pregnant, breastfeeding, or planning to become pregnant.
13) Any other individuals deemed unsuitable as participants in this trial by the principal investigator or other designated personnel.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Misaki |
| Middle name | |
| Last name | Hatanaka |
Organization
Asahi Group Foods, Ltd.
Division name
R&D Division, Technology Development Department I
Zip code
302-0106
Address
1-1-21 Midori, Moriya City, Ibaraki, Japan
TEL
0297-46-4105
misaki.hatanaka@asahi-gf.co.jp
Public contact
Name of contact person
| 1st name | Yota |
| Middle name | |
| Last name | Kobayashi |
Organization
Asahi Group Foods, Ltd.
Division name
R&D Division, Technology Development Department I
Zip code
302-0106
Address
1-1-21 Midori, Moriya City, Ibaraki, Japan
TEL
070-3187-3950
Homepage URL
yota.kobayashi@asahi-gf.co.jp
Sponsor or person
Institute
Asahi Group Foods, Ltd.
Institute
Department
Personal name
Funding Source
Organization
Asahi Group Foods, 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
Gokammachi, Maebashi-Shi, Gumma, 371-0813, Japan
Tel
027-261-7600
sagawa@mc-connect.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
医療法人前橋北病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 22 | 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 | 12 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study investigates the effects of added food components on the gut microbiota and related indicators using an in vitro system with human-derived fecal samples.
Management information
Registered date
| 2026 | Year | 06 | Month | 19 | Day |
Last modified on
| 2026 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070905
