UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059537 |
|---|---|
| Receipt number | R000067364 |
| Scientific Title | Low-Dose Oral Immunotherapy for Walnut Allergy in Children: A Multicenter, Double-Blind,Placebo-Controlled Randomized Trial |
| Date of disclosure of the study information | 2025/10/30 |
| Last modified on | 2025/10/23 16:23:54 |
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Basic information
Public title
A Multicenter Trial to Evaluate the Efficacy and Safety of Low-Dose Oral Immunotherapy for Walnut Allergy in Children
Acronym
Clinical trial of Low-Dose Oral Immunotherapy for Walnut Allergy in Children
Scientific Title
Low-Dose Oral Immunotherapy for Walnut Allergy in Children: A Multicenter, Double-Blind,Placebo-Controlled Randomized Trial
Scientific Title:Acronym
WALnut Low-dose Oral immunotherapy trial in Pediatrics(WALOP)
Region
| Japan |
Condition
Condition
food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy of oral immunotherapy for patients with walnut allergy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients achieving sustained unresponsiveness to 3.0g of walnut at 12 months from initiation
Key secondary outcomes
Proportion of patients achieving desensitization to 0.4g of walnut at 12 months from the
beginning of OIT
Change in symptom-eliciting threshold in challenge tests at 12 months from the beginning
of OIT
Frequency of adverse events during the first 12 months
Frequency of serious adverse events during the first 12 months
Frequency of epinephrine intramuscular injection during the first 12 months
Changes in walnut and walnut allergen component-specific IgE, IgG, and IgG4 levels
during the first 12 months
Changes in immune cell populations by single-cell analysis and interactome analysis
Prediction of sustained unresponsiveness
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
YES
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The follow-up period is 52 weeks.From the start date to 4 weeks, the walnut group begins with 10mg of walnut-containing foods. However, if the pre-existing symptom-eliciting threshold is 10mg or less of walnut, the intake amount begins at half the threshold value and continues. From 4 weeks onward, if asymptomatic for 7 days, the intake amount is increased by one step based on the dosing step table. The dose is increased up to the target amount of 0.4g of walnut (or placebo). After reaching the target amount, intake continues at the same dose. Once the target amount is consumed and the patient remains asymptomatic for 1 month, loratadine administration is discontinued.
Interventions/Control_2
The follow-up period is 52 weeks.The placebo group begins with 10mg of placebo. However, if the pre-existing symptom-eliciting threshold is 10mg or less of walnut, the intake amount begins at half the threshold value. From 4 weeks onward, if asymptomatic for 7 days, the intake amount is increased by one step based on the dosing step table. The dose is increased up to the target amount of 0.4g of placebo. After reaching the target amount, intake continues at the same dose. Once the target amount is consumed and the patient remains asymptomatic for 1 month, loratadine administration is discontinued.
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
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients aged 2 years or older and under 18 years at the time of trial treatment initiation (Day 1)
Patients who tested positive for walnut at 0.8g or less (walnut protein amount 116.8mg) by oral food challenge test
Patients from whom informed consent for participation in this study has been obtained from their legal guardian or from both the legal guardian and the patient
Key exclusion criteria
Patients with poorly controlled bronchial asthma (C-ACT or ACT score of 19 points or less)
Patients with severe atopic dermatitis (Eczema Area and Severity Index: EASI score of 16 points or more)
Patients undergoing other immunotherapy at the time of trial treatment initiation. However, patients who have been on sublingual immunotherapy (SLIT) or subcutaneous immunotherapy (SCIT) for cedar or dust mites for more than 1 year after initiation and are stable without adverse reactions may be permitted at the discretion of the attending physician.
Patients using anti-human IgE antibody preparations, anti-human IL-5 monoclonal antibody preparations, anti-human IL-13 monoclonal antibody preparations, anti-human IL-5 receptor preparations, anti-human IL-4/IL-13 receptor preparations, anti-human IL-31 receptor preparations, anti-human TSLP monoclonal antibody preparations, or JAK inhibitors (oral) at the time of trial treatment initiation
Patients using systemic steroids or immunosuppressive agents at the time of trial treatment initiation
Patients with comorbid diseases that affect the immune system (autoimmune diseases, immune complex diseases, immunodeficiency disorders, etc.)
Cases where the physician judges that trial execution would be difficult
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Sakura |
| Middle name | |
| Last name | Sato |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL
042-742-8311
ssakura8010@foodallergy.jp
Public contact
Name of contact person
| 1st name | Ken-ichi |
| Middle name | |
| Last name | Nagakura |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of pediatrics
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan,
TEL
042-742-8311
Homepage URL
k.nagakura@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
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
国立病院機構相模原病院 (神奈川県)
国立病院機構三重病院 (三重県)
昭和医科大学 (東京都)
宮城県立こども病院 (宮城県)
千葉大学
京都大学
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 30 | 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
| 2025 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 24 | Day |
Last modified on
| 2025 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067364
