UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058354 |
|---|---|
| Receipt number | R000066671 |
| Scientific Title | Effects of Ingestion of Lactic Acid Bacteria on Subjective Physical Symptoms in Children: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study. |
| Date of disclosure of the study information | 2025/07/03 |
| Last modified on | 2025/07/02 15:43:03 |
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Basic information
Public title
Effects of Ingestion of Lactic Acid Bacteria on Subjective Physical Symptoms in Children: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study.
Acronym
Effects of Ingestion of Lactic Acid Bacteria on Subjective Physical Symptoms in Children.
Scientific Title
Effects of Ingestion of Lactic Acid Bacteria on Subjective Physical Symptoms in Children: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study.
Scientific Title:Acronym
Effects of Ingestion of Lactic Acid Bacteria on Subjective Physical Symptoms in Children.
Region
| Japan |
Condition
Condition
Healthy children
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove benefits of lactic acid bacteria intake on cold symptoms in healthy children.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of days and duration of cold symptoms
Number of fever days
Number of vomiting
Number of days of antibiotics use
Number of days absent from nursery school or kindergarten
Number of days and duration of diarrhea
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
Daily ingestion of powdered lactic acid bacteria for 24 weeks.
Interventions/Control_2
Daily ingestion of placebo powder for 24 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
| 2 | years-old | <= |
Age-upper limit
| 6 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects who are between the ages of 2 and 5 years old.
2. Subjects whose parents agree to participate in this study with a written informed consent.
Key exclusion criteria
1. Subjects with serious hepatic, renal, cardiac, lung, gastrointestinal, blood, brain, endocrine or metabolic diseases, and/or with serious medical history of those disease.
2. Subjects who regularly use oral or nasal medications.
3. Subjects who regularly use steroids.
4. Subjects who regularly take foods that affect immune function.
5. Subjects with severe perennial and/or seasonal allergic symptoms.
6. Subjects at risk of allergic reactions to drugs or foods.
7. Subjects who participated in clinical studies of other drugs and foods within the last 4 weeks prior to the current study.
8. Subjects who are deemed ineligible by the principal investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | NISHIHIRA |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
hisc-acad.res@s.do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | HONMA |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
Homepage URL
hisc-acad.res@s.do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Hokkaido Information University
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel
011-385-4411
soumu@do-johodai.ac.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
北海道情報大学 保健センター（北海道）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 03 | 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 | 06 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | 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 | 07 | Month | 03 | Day |
Last modified on
| 2025 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066671
