UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060581 |
|---|---|
| Receipt number | R000065121 |
| Scientific Title | Randomized trial of weaning food for prevention of peanut and nut allergy |
| Date of disclosure of the study information | 2026/02/04 |
| Last modified on | 2026/02/04 15:05:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Randomized trial of weaning food for prevention of peanut and nut allergy
Acronym
Randomized trial for prevention of peanut and nut allergy
Scientific Title
Randomized trial of weaning food for prevention of peanut and nut allergy
Scientific Title:Acronym
Randomized trial for prevention of peanut and nut allergy
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether early consumption of peanut, walnut, and cashew with weaning food can prevent development of these allergies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitization to peanut, walnut, and cashew at the age of two
Key secondary outcomes
Percentage of patients with allergic symptoms to peanuts, walnuts, or cashews at age two
Percentage of patients with allergic symptoms to foods other than peanuts, walnuts, and cashews at age two
Percentage of patients with sensitization to peanuts, walnuts, cashews, Ara h 2, Jug r 1, Ana o 3, respectively, up to two years of age
Specific IgE level for peanuts, walnuts, cashews, Ara h 2, Jug r 1, Ana o 3, at 1 year 6 months and 2 years
Specific IgG and IgG4 level for peanuts, walnuts, and cashews at 1 year 6 months and 2 years
The results of peanut, walnut, and cashew oral food challenge test in sensitized children
Safety and adverse events related to the trial weaning food
Frequency of trial weaning food intake
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consume weaning food with peanuts, walnuts, and cashews at least twice a week from 1 year to 1 year and 6 months
Interventions/Control_2
Consume placebo weaning food at least twice a week from 1 year to 1 year and 6 months
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
| 6 | months-old | <= |
Age-upper limit
| 12 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Infants under 1 year of age at the time of study enrollment who have sensitization to one or more food allergens by blood test between 6 to 11 months of age.
Key exclusion criteria
Severe atopic dermatitis
Infants with a history of immediate symptoms to peanuts, walnuts, or cashews
Infants with sensitization to peanuts, walnuts, cashews, Ara h 2, Jug r 1, or Ana o 3 by blood test
Infants with concomitant immune disorders
Infants with a history or complications of cardiac, liver, kidney, or blood disease
Infants using systemic steroids regularly
Infants using systemic biologics
Decision of ineligibility by a physician
Target sample size
136
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Yanagida |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Pediatrics
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL
042-742-8311
yana@foodallergy.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Yanagida |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Pediatrics
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL
042-742-8311
Homepage URL
yana@foodallergy.jp
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Miyagi Children's Hospital
Aichi Children's Health and Medical Center
Showa Medical University Hospital
National Hospital Organization Mie National Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Sagamihara National Hospital
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
Tel
042-742-8311
makino.megumi.bn@mail.hosp.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 | 02 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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 | 02 | Month | 04 | Day |
Last modified on
| 2026 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065121
