UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050084 |
|---|---|
| Receipt number | R000057055 |
| Scientific Title | Effect of bifidobacteria (heat-killed B. bifidum OLB6378) intervention in early childhood on intestinal IgA production. |
| Date of disclosure of the study information | 2023/02/01 |
| Last modified on | 2024/02/02 14:41:15 |
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Basic information
Public title
Effect of bifidobacteria (heat-killed B. bifidum OLB6378) intervention in early childhood on intestinal IgA production (exploratory research).
Acronym
Effect of bifidobacteria (heat-killed B. bifidum OLB6378) intervention in early childhood on intestinal IgA production.
Scientific Title
Effect of bifidobacteria (heat-killed B. bifidum OLB6378) intervention in early childhood on intestinal IgA production.
Scientific Title:Acronym
Effect of bifidobacteria (heat-killed B. bifidum OLB6378) intervention in early childhood on intestinal IgA production.
Region
| Japan |
Condition
Condition
Healthy children
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effects on the intestinal IgA production increase and the number of intestinal bifidobacteria when heat-killed B. bifidum OLB6378 cells are continuously ingested for 2 weeks in children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In fecal IgA.
In fecal total bifidobacterial count.
In fecal total B. bifidum count.
In fecal total B. bifidum OLB6378 count.
Key secondary outcomes
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
| Food |
Interventions/Control_1
1 bottle per day 125mL
2 weeks intake
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
| 1 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Children (1-6 years old)
2) Employee's child of the Meiji Co., Ltd.
3) Children whose mothers understand the purpose and content of this research and do not refuse to participate in this research as children's legally acceptable representative.
Key exclusion criteria
1) Those with milk allergy
2) Those with lactose intolerance
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Nakamura |
Organization
Meiji Co., Ltd.
Division name
Nutrition and Food Function Group, Nutrition and Food Function Research Department, Food Microbiology and Function Research Laboratories, R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo, 192-0919, JAPAN
TEL
042-632-5848
yoshitaka.nakamura@meiji.com
Public contact
Name of contact person
| 1st name | Megumu |
| Middle name | |
| Last name | Igawa |
Organization
Meiji Co., Ltd.
Division name
Nutrition and Food Function Group, Nutrition and Food Function Research Department, Food Microbiolog
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo, 192-0919, JAPAN
TEL
042-632-5848
Homepage URL
megumu.igawa@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
| 2023 | Year | 02 | Month | 01 | 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
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 01 | Month | 19 | Day |
Last modified on
| 2024 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057055
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
