UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059060 |
|---|---|
| Receipt number | R000067555 |
| Scientific Title | Exploratory Study to Evaluate the Impact of Prebiotic Intake on the Gut Microbiota and Health Status |
| Date of disclosure of the study information | 2025/09/11 |
| Last modified on | 2025/09/11 17:10:03 |
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Basic information
Public title
Exploratory Study to Evaluate the Impact of Prebiotic Intake on the Gut Microbiota and Health Status
Acronym
Exploratory Study to Evaluate the Impact of Prebiotic Intake on the Gut Microbiota and Health Status
Scientific Title
Exploratory Study to Evaluate the Impact of Prebiotic Intake on the Gut Microbiota and Health Status
Scientific Title:Acronym
Exploratory Study to Evaluate the Impact of Prebiotic Intake on the Gut Microbiota and Health Status
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect on gut microbiota and health status by administration of oligosaccharide for 4 weeks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Gut microbiota, Intestinal barrier function, Systemic inflammation, Muscle proteolysis, Frailty indicators, Bowel habits, Gastrointestinal symptoms, Quality of life, Sleep, Fatigue, Vitality, Mental health
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of oligosaccharide for 4 weeks
Interventions/Control_2
Oral ingestion of placebo for 4 weeks
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy adults aged 20-64 years at the time of consent
2. Persons who, after adequate explanation of the study purpose and procedures, have the capacity to consent, understand the information, and voluntarily provide informed consent to participate
Key exclusion criteria
1. History of gastric or lower gastrointestinal surgery (excluding hemorrhoid surgery and polypectomy)
2. Current serious disease affecting the liver, kidneys, heart, lungs, or gastrointestinal tract, or other organ dysfunction; diabetes mellitus; rheumatoid arthritis; neurological or psychiatric disorders; sleep disorders; chronic fatigue syndrome; or any other serious or progressive disease
3. Underwent gastric X-ray barium examination or bowel cleansing (in a clinic or at home) within 1 month prior to screening, or plans to undergo these during the study
4. Took any antibiotic at least once within 1 month prior to screening, or is taking at least weekly-or plans to take during the study-any medication that may affect the study (e.g., proton-pump inhibitors, antidiabetic drugs such as metformin, laxatives such as magnesium oxide, or ursodeoxycholic acid)
5. Current smoker within 1 month prior to consent
6. Plans for overseas travel, or trips/business travel longer than 1 week, from the date of consent until completion of the 4-week post-consent assessment
7. Average daily alcohol consumption exceeds sixty grams of ethanol
8. Irregular lifestyle due to shift or night work
9. Performing resistance training more than 4 times per week (e.g., weight training with barbells, dumbbells, or machines)
10. Presence of food allergies
11. Pregnant, lactating, or possibly pregnant
12. Any other condition judged by the principal or sub-investigator to be inappropriate for study participation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kano |
Organization
Meiji Holdings Co., Ltd.
Division name
Wellness Science Labs
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo, Japan
TEL
042-632-5838
hiroshi.kano@meiji.com
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
Meiji Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Holdings Co., Ltd.
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Meiji Co., Ltd.
Chiyoda Paramedical Care Clinic
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-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
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
チヨダパラメディカルケアクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 11 | 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 | 08 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 11 | 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 | 09 | Month | 11 | Day |
Last modified on
| 2025 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067555
