UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063503 |
|---|---|
| Receipt number | R000072680 |
| Scientific Title | Safety and Feasibility of Powdered Nut-Based Recipes in Infants at High Risk for Food Allergy: A Prospective Intervention Study |
| Date of disclosure of the study information | 2026/11/03 |
| Last modified on | 2026/11/02 20:20:20 |
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Basic information
Public title
Evaluation of the Safety and Feasibility of Powdered Nut Recipes in Infants at High Risk for Food Allergy
Acronym
Evaluation of the Safety and Feasibility of Powdered Nut Recipes in Infants
Scientific Title
Safety and Feasibility of Powdered Nut-Based Recipes in Infants at High Risk for Food Allergy: A Prospective Intervention Study
Scientific Title:Acronym
Hi-NUT Study High-Risk Infant Nut Introduction Study
Region
| Japan |
Condition
Condition
Eczema
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and feasibility of powdered peanut and tree nut recipes for complementary feeding in infants with eczema who are at high risk of developing food allergy.
Basic objectives2
Others
Basic objectives -Others
An exploratory study aimed at developing a practical approach to early nut introduction in infants at high risk for food allergy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility of powdered nut-based recipes, assessed using a caregiver-reported questionnaire evaluating ease of preparation, reproducibility, willingness to continue feeding, and satisfaction on a 5-point scale. Feasibility is defined as a total score of at least three times the number of evaluated items.
Key secondary outcomes
Incidence of adverse events associated with consumption of powdered nut-based recipes, including allergic reactions, aspiration, and choking.
Nut consumption during the 2-month follow-up period, assessed by caregiver-reported questionnaires. Regular consumption is defined as intake at least three times per week.
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
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Caregivers will be provided with complementary food recipes using powdered peanut and tree nuts (walnut, cashew, almond, and hazelnut). At enrollment, caregivers will prepare the food, and infants will consume it under medical supervision. Subsequently, caregivers will prepare and provide the foods at home for 2 months. The initial dose will be individually determined by a physician based on the infant's eczema status, age, and other relevant factors.
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
Infants aged 5 to 18 months at enrollment.
Infants who have received topical corticosteroids or other anti-inflammatory treatments for eczema on multiple occasions before enrollment.
Infants whose legal guardians have provided written informed consent.
Key exclusion criteria
Infants with poorly controlled eczema.
Infants with a history of nut allergy.
Infants who have never consumed wheat.
Infants unable to consume age-appropriate complementary foods due to swallowing difficulties or other conditions.
Infants whose caregivers cannot communicate adequately in Japanese.
Infants with medical conditions that may interfere with study participation.
Infants whose legal guardians are unable to comply with the prohibition on disclosing study information and recipes.
Infants deemed unsuitable for participation by the investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kiwako |
| Middle name | Hanada |
| Last name | Yamamoto |
Organization
National Center for Child Health and Development
Division name
Allergy Center
Zip code
157-8535
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan
TEL
03-3416-0181
yamamoto-k@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Sayaka |
| Middle name | |
| Last name | Hamaguchi |
Organization
National Center for Child Health and Development
Division name
Allergy Center
Zip code
157-8535
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan
TEL
03-3416-0181
Homepage URL
hamaguchi-sa@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
National Center for Child Health and Development
Organization
Division
Category of Funding Organization
Other
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 Ethics Review Committee Secretariat
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan
Tel
03-5494-7243
rinri@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 | 11 | 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
30
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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 01 | 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 | 11 | Month | 02 | Day |
Last modified on
| 2026 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072680
