UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060261 |
|---|---|
| Receipt number | R000068931 |
| Scientific Title | Evaluation study on the effects of digestive improvement on the intestinal environment |
| Date of disclosure of the study information | 2026/01/05 |
| Last modified on | 2026/01/05 17:28:55 |
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Basic information
Public title
Evaluation study on the effects of digestive improvement on the intestinal environment
Acronym
Evaluation study on the effects of digestive improvement on the intestinal environment
Scientific Title
Evaluation study on the effects of digestive improvement on the intestinal environment
Scientific Title:Acronym
Evaluation study on the effects of digestive improvement on the intestinal environment
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the impact of improving digestion in the upper gastrointestinal tract on the intestinal environment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut microbiota/Gut metabolomes
Key secondary outcomes
1. Defecation status (frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, odor)
2. Abdominal symptoms (bloating, belching, gas (flatus frequency)) at times other than during defecation
3. Fecal cultivation assay
- Cultivated microbiota
- Cultivated metabolomes
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
| Other |
Interventions/Control_1
Consumption of test sample (9 tablets per day for 4 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) At informed consent, male/female subjects aged more than or equal to 20, and less than 65 years old.
(2) Subjects who can show their understanding of the study procedure and agreement with participating in the study by informed consent prior to the study.
Key exclusion criteria
(1) Subjects who regularly take digestive enzyme products and are unable to discontinue consumption of the products from the time consent is obtained, or those who plan to consume such products during the study.
(2) Subjects who are unable to discontinue consumption of foods for specified health uses, foods with function claims, health foods that may affect the study (intestinal regulation, etc.) from the time consent is obtained.
(3) Subjects who are unable to discontinue consumption of supplements (including tablets, capsules, and other forms distinct from ordinary foodstuffs, taken for nutritonal or functional puposes regardless of ingredients or functionality) from the time consent is obtained.
(4) Subjects who have taken drugs (antibiotics, antiflatulent, laxatives, etc.) that would affect the study one month prior to the pre-test, or those sho plant to take during the study.
(5) Subjects who have undergone surgery that may affect the study (colonoscopy, removal of gallstones or gall bladder, gastric bypass surgery, bariatric surgery, etc.) within 6 months prior to obtaining consent.
(6) Subjects who are expected to undergo a major change in their family, work, or other living environment (e.g., relocation, transfer, etc.) during the study.
(7) Subjects with extremely irregular eating habits.
(8) Subjects who have been diagnosed with kidney disease.
(9) Subjects undergoing dialysis therapy.
(10) Subjects with a history of serious diseases of the heart, liver, kidneys, digestive organs, etc.
(11) Pregnant, lactating, or intending to become pregnant during the study.
(12) Subjects allergic to medicines and foods.
(13) Participating in a clinical study of another drug or health food, within 4 weeks of the completion of the study, or who is scheduled to participate in another clinical study after consent to participate in this study.
(14) Those who are judged by the principal investigator to be inappropriate to participate in this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tatsuhiro |
| Middle name | |
| Last name | Nomaguchi |
Organization
Metagen, Inc.
Division name
Product Development Support Division
Zip code
997-0052
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata 997-052, Japan
TEL
+81-235-64-0330
research@metagen.co.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Ishigaki |
Organization
Amano Enzyme Inc.
Division name
Carbohydrate and Food Processing Team, Development Dept.-I, Innovation Division
Zip code
509-0109
Address
1-6 Techno Plaza, Kakamigahara City, Gifu Prefecture, 509-0109 Japan
TEL
+81-58-379-1221
Homepage URL
yuki_ishigaki@amano-enzyme.com
Sponsor or person
Institute
Metagen, Inc.
Institute
Department
Personal name
Funding Source
Organization
Amano Enzyme Inc.
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongokucho, Chuo-ku, Tokyo 103-0021, Japan
Tel
+81-3-6225-9005
IRB@cpcc.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 | 01 | Month | 05 | 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
| 2025 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 02 | 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 | 01 | Month | 05 | Day |
Last modified on
| 2026 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068931
