UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063360 |
|---|---|
| Receipt number | R000072521 |
| Scientific Title | Exploratory study on the effects of intake of "Kodomo Cho-miso" on gut microbiota and quality of life (QOL) in children |
| Date of disclosure of the study information | 2026/10/20 |
| Last modified on | 2026/10/20 17:46:48 |
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Basic information
Public title
Exploratory study on the effects of intake of "Kodomo Cho-miso" on gut microbiota and quality of life (QOL) in children
Acronym
Exploratory study on the effects of intake of "Kodomo Cho-miso" on gut microbiota and quality of life (QOL) in children
Scientific Title
Exploratory study on the effects of intake of "Kodomo Cho-miso" on gut microbiota and quality of life (QOL) in children
Scientific Title:Acronym
Exploratory study on the effects of intake of "Kodomo Cho-miso" on gut microbiota and quality of life (QOL) in children
Region
| Japan |
Condition
Condition
Healthy child
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratorily evaluate the changes in gut microbiota and parent-reported abdominal QOL, daily life (behavior/emotion), and defecation status when ingested continuously for 4 weeks in children aged 9 months to 6 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut microbiota (change in occupancy rate of genus Bifidobacterium) at the beginning of or after the intake for 4 weeks, Infant/Toddler Belly-QOL shortened version 12 items (change in shortened total score) at the beginning of or after the intake for 4 weeks.
Key secondary outcomes
Gut microbiota (changes in alpha diversity [Shannon index, etc.], beta diversity, occupancy rate of major bacterial groups such as butyrate-producing bacteria) at the beginning of or after the intake for 4 weeks; Infant/Toddler Belly-QOL shortened version 12 items (changes in symptom burden score, tummy QOL score, and overall evaluation score) at the beginning of or after the intake for 4 weeks; VAS 14 items (changes in 7 items of tummy symptoms + 7 items of daily life [sleep, mood, emotional calmness, behavioral calmness, activity, meal, overall]) at the beginning of or after the intake for 4 weeks; Defecation status 3 items (changes in defecation frequency in the past 7 days, most common stool form, frequency of painful defecation) at the beginning of or after the intake for 4 weeks; Subjective and objective findings during 4 weeks of intake (reports of physical condition changes from guardians, adverse events).
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
Intake daily for 4 weeks (28 days) once a day of the test food dissolved in hot water according to age in months (9-11 months: 2 g, 1-2 years: 4 g, 3-5 years: 5 g, 6 years and older: 7 g).
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
| 9 | months-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Children whose surrogates (guardians) have received sufficient explanation about the purpose and contents of this study, fully understand it, and have agreed to the participation of the study subjects of their own free will
2. Japanese children aged between 9 months and 6 years at the time of obtaining consent (guideline: after completion of baby food)
3. Persons who can incorporate the test food into their diet almost every day for 4 weeks
Key exclusion criteria
1. Persons who are allergic to the raw materials of the test food, or are undergoing close examination for food allergies
2. Persons who have chronic gastrointestinal diseases, renal dysfunction, diseases requiring sodium (salt) restriction, etc. and are receiving treatment, or have a serious disease history
3. Persons who have taken antibiotics within 4 weeks before the start of the study
4. Persons who regularly use supplements such as probiotics and prebiotics, or foods with health claims that may affect the intestinal environment, and cannot stop taking them
5. Persons who usually take a large amount of miso products of the same type as the test food
6. Persons who have participated in other studies within 1 month before the start of the study, or who intend to participate in other studies after consenting to this study
7. Persons who were judged as inappropriate for study participants by the principal investigator
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Tochio |
Organization
Biosis Lab Co., Ltd.
Division name
CEO
Zip code
470-1192
Address
Room 506, Building No. 11, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, JAPAN
TEL
090-6904-6772
takumitochiobiz@gmail.com
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Tochio |
Organization
Biosis Lab Co., Ltd.
Division name
CEO
Zip code
470-1192
Address
Room 506, Building No. 11, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, JAPAN
TEL
090-6904-6772
Homepage URL
takumitochiobiz@gmail.com
Sponsor or person
Institute
Biosis Lab Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
SUNAO Pharmaceutical 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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 20 | 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 | 25 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2026 | Year | 10 | Month | 20 | Day |
Last modified on
| 2026 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072521
