UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059845 |
|---|---|
| Receipt number | R000068434 |
| Scientific Title | A retrospective observational study on the association between the intake of lactic acid bacteria-containing food products and the incidence of infections in children |
| Date of disclosure of the study information | 2025/11/24 |
| Last modified on | 2025/11/20 19:30:02 |
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Basic information
Public title
A retrospective observational study on the association between the intake of lactic acid bacteria-containing food products and the incidence of infections in children
Acronym
A retrospective observational study on the association between the intake of lactic acid bacteria-containing food products and the incidence of infections in children
Scientific Title
A retrospective observational study on the association between the intake of lactic acid bacteria-containing food products and the incidence of infections in children
Scientific Title:Acronym
A retrospective observational study on the association between the intake of lactic acid bacteria-containing food products and the incidence of infections in children
Region
| Japan |
Condition
Condition
Children or Elementary School Students
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the association between the intake of lactic acid bacteria-containing food products and the incidence of infections in children
Basic objectives2
Others
Basic objectives -Others
Evaluate the association between the intake of lactic acid bacteria-containing food products and the incidence of infections in children
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between the intake of lactic acid bacteria-containing food products and the incidence of infections
Key secondary outcomes
Correlation between the frequency of intake of lactic acid bacteria-containing food products and the incidence of infections
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 3 | years-old | <= |
Age-upper limit
| 10 | years-old | > |
Gender
Male and Female
Key inclusion criteria
preschool children aged 3 to 6 or elementary school students in grades 1 through 3
Key exclusion criteria
None
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Saito |
Organization
Ezaki Glico Co., Ltd.
Division name
R&D Laboratory
Zip code
555-8502
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka-shi, Osaka
TEL
090-4003-6652
yasuo.saito@glico.com
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Matsuda |
Organization
Ezaki Glico Co., Ltd.
Division name
R&D Laboratory
Zip code
555-8502
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka-shi, Osaka
TEL
070-2829-7109
Homepage URL
hiroki.matsuda2@glico.com
Sponsor or person
Institute
Ezaki Glico Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of Glico Group
Address
4-6-5, Utajima, Nishiyodogawa-ku, Osaka, 555-8502, Japan
Tel
+81-6-6477-8793
dl_rinriiinkai_jimukyoku@glico.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 | 11 | Month | 24 | 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 | 10 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate the association between the intake of lactic acid bacteria-containing food products and the incidence of infections in children
Management information
Registered date
| 2025 | Year | 11 | Month | 21 | Day |
Last modified on
| 2025 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068434
