UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062803 |
|---|---|
| Receipt number | R000071738 |
| Scientific Title | A study on the effects of continuous intake of test food on cold-like symptoms in infants and school children: A randomized, double-blind, placebo-controlled, parallel-group study |
| Date of disclosure of the study information | 2026/09/03 |
| Last modified on | 2026/09/03 14:21:50 |
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Basic information
Public title
A study on the effects of continuous intake of test food on cold-like symptoms in infants and school children
Acronym
A study on the effects of continuous intake of test food on cold-like symptoms in infants and school children
Scientific Title
A study on the effects of continuous intake of test food on cold-like symptoms in infants and school children: A randomized, double-blind, placebo-controlled, parallel-group study
Scientific Title:Acronym
A study on the effects of continuous intake of test food on cold-like symptoms in infants and school children: A randomized, double-blind, placebo-controlled, parallel-group study
Region
| Japan |
Condition
Condition
Healthy participants
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of 12-week continuous intake of the test food on cold-like symptoms in infants and school children through a randomized, double-blind, placebo-controlled, parallel-group study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
CARIFS: Number of cold/influenza episodes
Key secondary outcomes
(1) CARIFS score
(2) Status of common cold-like symptoms (cumulative incidence, duration of illness)
(3) Frequency of antipyretic and cold medication use
(4) Frequency of medical consultations
(5) Number of days absent from school/nursery
(6) Allergic symptoms
(7) Abdominal symptoms
(8) Defecation log (defecation frequency, stool consistency evaluated by Bristol Stool Form Scale)
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
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Continuous intake of the test food for 12 weeks
Interventions/Control_2
Continuous intake of the placebo food for 12 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
| 3 | years-old | <= |
Age-upper limit
| 12 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Male or female subjects aged 3 to 12 years old at the time of obtaining consent.
(2) Children enrolled in and attending school, kindergarten, or nursery school.
(3) Parents (or legal guardians) who can reliably bring the subject to all scheduled visits and accurately complete daily diaries and questionnaires.
(4) Parents or legal guardians who have received sufficient explanation regarding the purpose and content of the study, fully understand it, voluntarily apply for the subject's participation, and provide written or electronic informed consent. In addition, subjects who receive an explanation appropriate for their age and level of understanding, and give written, verbal, or electronic informed assent.
Key exclusion criteria
(1) Subjects with chronic diseases (such as bronchial asthma or atopic dermatitis) undergoing medical treatment or medication.
(2) Subjects who regularly use intestinal regulators or laxatives.
(3) Subjects with a history of serious cerebrovascular, cardiac, hepatic, renal, hematologic, metabolic, endocrine, or respiratory diseases.
(4) Subjects with immune dysfunction or taking immunosuppressive drugs (e.g., cyclosporine, methotrexate, azathioprine).
(5) Subjects diagnosed with developmental disorders (autism spectrum disorder, ADHD, etc.).
(6) Subjects with significant abnormalities in vital signs or physical examination at screening.
(7) Subjects with food or drug allergies.
(8) Subjects with a history of epilepsy or seizures with loss of consciousness and currently under medical treatment or medication.
(9) Subjects with a history of anaphylactic shock.
(10) Subjects who regularly consume Foods for Specified Health Uses, Foods with Function Claims, or health supplements and cannot refrain from taking them during the study.
(11) Subjects with extremely irregular sleep habits or dietary habits.
(12) Subjects whose living environment (relocation, change of school/nursery, change in family composition) or dietary/exercise habits may change significantly during the study.
(13) Subjects currently participating in other clinical studies, or who participated within 4 weeks prior to screening, or plan to participate during this study.
(14) Subjects deemed ineligible by the principal investigator.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill Carenet, Inc.
Division name
Clinical Research Solution Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-7108
umin_info@macromillcarenet.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Kimoto |
Organization
Macromill Carenet, Inc.
Division name
Clinical Research Solution Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-7108
Homepage URL
umin_info@macromillcarenet.jp
Sponsor or person
Institute
Macromill Carenet, Inc.
Institute
Department
Personal name
Funding Source
Organization
HOUSE WELLNESS FOODS CORPORATION
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
Institutional review board of Tsukiji Futaba Clinic
Address
1-9-9, Tsukiji, Chuou-ku, Tokyo, Japan
Tel
03-6226-5812
tohru@hikobae.net
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
医療法人社団曙光会コンフォガーデンクリニック
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | 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
| 2026 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 03 | Day |
Last modified on
| 2026 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071738
