UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061425 |
|---|---|
| Receipt number | R000070286 |
| Scientific Title | Single-Group Intervention Study on the Early Introduction of Multiple Nuts Using a Mixed Powder Formula for Infants |
| Date of disclosure of the study information | 2026/05/10 |
| Last modified on | 2026/04/30 23:11:29 |
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Basic information
Public title
Single-Group Intervention Study on the Early Introduction of Multiple Nuts Using a Mixed Powder Formula for Infants
Acronym
Prospective Study on Early Consumption of Mixed Nut Powder
Scientific Title
Single-Group Intervention Study on the Early Introduction of Multiple Nuts Using a Mixed Powder Formula for Infants
Scientific Title:Acronym
Prospective Study on Early Consumption of Mixed Nut Powder
Region
| Japan |
Condition
Condition
food allergy
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the safety and feasibility of long term consumption of a mixed peanut and nut powder developed to be easily and safely consumed by infants and young children without food allergies in their homes.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
feasibility of consumption of mixed nuts powder
Key secondary outcomes
Adverse events related to administration
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Participants will visit the National Center for Child Health and Development, where consent will be obtained from the subjects' parent or legal guardian before the case is registered. After registration, the subject will be given the mixed powder mixed into baby food, and a physician will assess for the occurrence of immediate type allergic reactions. For those confirmed to be able to consume the mixture without adverse events, the mixed powder will be provided for continued consumption at home for two months. If safety and tolerability are confirmed every two months, the dose will be increased as in the initial phase.
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
| 5 | months-old | <= |
Age-upper limit
| 18 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Children aged 5 months to 1 year and 6 months at the start of the study, along with their guardians.
Participants for whom consent has been obtained from a legal guardian acting as a proxy.
Key exclusion criteria
1. Children with active eczema at the time of enrollment
2. Children with a history of or concurrent food allergies
3. Children who, due to swallowing difficulties or other reasons, are unable to consume weaning foods of a consistency appropriate for their age
4. Children whose caregivers are unable to communicate effectively in Japanese
5. Children suffering from a medical condition that would interfere with this study
6. Children deemed unsuitable by a physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Harama |
Organization
National Center for Child Health and Development
Division name
Medical support center for Japan Environment and Children's Study
Zip code
157-8535
Address
Okura 2-10-1, Setagaya-ku, Tokyo, Japan
TEL
03-3416-0611
harama-d@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Harama |
Organization
National Center for Child Health and Development
Division name
Medical support center for Japan Environment and Children's Study
Zip code
157-8535
Address
Okura 2-10-1, Setagaya-ku, Tokyo, Japan
TEL
03-3416-0611
Homepage URL
harama-d@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
Urakami Foundation for Food and Food Culture Promotion
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Child Health and Development
Address
Okura 2-10-1, Setagaya-ku, Tokyo, Japan
Tel
03-3416-0611
harama-d@ncchd.go.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 | 05 | Month | 10 | 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 | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 02 | Month | 28 | 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 | 04 | Month | 30 | Day |
Last modified on
| 2026 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070286
