UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054345 |
|---|---|
| Receipt number | R000062084 |
| Scientific Title | Study of the effect on the gut microbiota by ingestion of lactic acid bacteria |
| Date of disclosure of the study information | 2024/05/10 |
| Last modified on | 2024/05/09 11:26:28 |
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Basic information
Public title
Study of the effect on the gut microbiota by ingestion of lactic acid bacteria
Acronym
Study of the effect on the gut microbiota by ingestion of lactic acid bacteria
Scientific Title
Study of the effect on the gut microbiota by ingestion of lactic acid bacteria
Scientific Title:Acronym
Study of the effect on the gut microbiota by ingestion of lactic acid bacteria
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect on gut microbiota by administration of target lactic acid bacteria for 2 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Gut microbiota 2 weeks after intake
Key secondary outcomes
Mental health 2 weeks after intake
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of target lactic acid bacteria for 2 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Those who provided specimens in which target lactic acid bacteria increased the number of useful bacteria compared to the control in vitro
2.Those whose place of work is at Meiji Innovation Center at the time of obtaining consent
3.Those who have received sufficient explanation about the purpose and content of this study, have the ability to consent, fully volunteered with voluntary intention, agreed to participate
Key exclusion criteria
1.Those who have participated in a study involving an intervention that is expected to affect our study, such as continuous consumption of foods expected to regulate the intestines during the month prior to screening, or those who plan to participate in a study involving a similar intervention during the period between screening and the end of the intake period.
2.Those who have a history of gastric or lower gastrointestinal tract surgery (excluding hemorrhoids and polypectomy)
3.Those who have a barium stomach X-ray, small or large intestine endoscopy, or bowel cleansing at a clinic or at home during the month prior to screening, or those who are scheduled to have these procedures during this study
4.Those who have taken, ingested, or used drugs that may affect the study (antibacterial agents [e.g., antibiotics], gastric acid secretion inhibitors [e.g., PPI], diabetes medications [e.g., metformin], laxatives [e.g., magnesium oxide], bile acid promoters [e.g., UDCA]) at least once a week during the month prior to screening, or who plan to take, ingest, or use these drugs at least once during the study
5.Those who plan to travel abroad, travel for more than one week, or go on a business trip during the period from one week prior to the intake period to the end of the intake period
6.Those with food allergies
7.Pregnant or lactating women
8.Subjects judged as unsuitable for the study by the principal investigator or research physician for other reasons
Target sample size
59
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
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
| 2024 | Year | 05 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 09 | Day |
Last modified on
| 2024 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062084
