UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056730 |
|---|---|
| Receipt number | R000064739 |
| Scientific Title | Study of the effect on the gut microbiota by ingestion of probiotics |
| Date of disclosure of the study information | 2025/01/16 |
| Last modified on | 2025/01/16 10:08:15 |
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Basic information
Public title
Study of the effect on the gut microbiota by ingestion of probiotics
Acronym
Study of the effect on the gut microbiota by ingestion of probiotics
Scientific Title
Study of the effect on the gut microbiota by ingestion of probiotics
Scientific Title:Acronym
Study of the effect on the gut microbiota by ingestion of probiotics
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effects of continuous consumption of test food for 4 weeks on gut microbiota, compared to the consumption of a control food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Composition and diversity of the intestinal microbiota after 0, 2 and 4 weeks of intake
Key secondary outcomes
Stool shape
Status of fatigue
Sleep habits
Frequency of defecation
Skin condition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of the probiotic-containing test food (1 bottle per day) for 4 weeks
Interventions/Control_2
Consumption of the 10x probiotic-containing test food (1 bottle per day) for 4 weeks
Interventions/Control_3
Consumption of the placebo food (1 bottle per day) for 4 weeks
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 men and women aged 20 to 64 years at the time of consent acquisition.
The definition of a healthy subjects is as follows:
-who have no history of gastrointestinal laparotomy.
-who have not visited a medical institution within the past month.
-who are not currently taking prescription oral or injectable medications (excluding eye drops or ointments).
2. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects with a history of laparoscopic surgery of the upper digestive tract (esophagus, stomach, duodenum) or laparoscopic surgery of the lower digestive tract (small intestine, large intestine, rectum). (excluding hemorrhoids, polypectomy and endoscopic treatment).
2. Subjects who have undergone gastric X-ray barium examination, small bowel endoscopy, colonoscopy, or bowel cleansing, or taken 2 L laxatives at a clinic or at home in the month prior to the date of consent or are scheduled to do so before the date stool collection after completion of intake.
3. Subjects who plan to take prescribed oral or injectable medications (not including eye drops or ointments) the date of stool collection after completion of intake.
4. Subjects with habits of consuming milk, yogurt, lactobacillus beverages, lactobacillus or bifidobacteria supplements, or probiotics at least once a week during the month prior to the date of consent (excluding subjects who can discontinue their intake from the date of consent until stool collection after completion of intake).
5. Subjects planning to travel abroad, for more than one week, or on a business trip between the date of consent and the date of stool collection after completion of intake.
6. Subjects with allergic to milk
7. Pregnant, lactating, or possibly pregnant.
8. Subjects deemed unsuitable participation in the trial by the principal investigator.
Target sample size
99
Research contact person
Name of lead principal investigator
| 1st name | Seiya |
| Middle name | |
| Last name | Makino |
Organization
Meiji Holdings Co., Ltd.
Division name
Wellness Science Labs
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo
TEL
042-632-5838
seiya.makino@meiji.com
Public contact
Name of contact person
| 1st name | Seiya |
| Middle name | |
| Last name | Makino |
Organization
Meiji Holdings Co., Ltd.
Division name
Wellness Science Labs
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo
TEL
042-632-5838
Homepage URL
seiya.makino@meiji.com
Sponsor or person
Institute
Meiji Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Holdings 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
Meiji Institutional Review Board
Address
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
Tel
042-632-5900
MEIJI.IRB@meiji.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 | 01 | Month | 16 | 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
| 2024 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 28 | 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 | 01 | Month | 16 | Day |
Last modified on
| 2025 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064739
