UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061465 |
|---|---|
| Receipt number | R000070339 |
| Scientific Title | An exploratory clinical study on the usefulness of sublingual immunotherapy using micro-dose nut allergens measured with an EpiPen trainer as a mold |
| Date of disclosure of the study information | 2026/05/07 |
| Last modified on | 2026/05/07 10:47:04 |
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Basic information
Public title
A study of sublingual immunotherapy using small amounts of nut powder for children with nut allergy
Acronym
Nut Allergy SLIT Study
Scientific Title
An exploratory clinical study on the usefulness of sublingual immunotherapy using micro-dose nut allergens measured with an EpiPen trainer as a mold
Scientific Title:Acronym
Nut SLIT Study
Region
| Japan |
Condition
Condition
Nut allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and feasibility of sublingual immunotherapy using micro-dose nut powder measured with the hollow of an EpiPen trainer cap in children with nut allergy, and to explore changes in nut tolerance over 24 months of intervention.
Basic objectives2
Others
Basic objectives -Others
Evaluation of safety and feasibility, with exploratory assessment of changes in tolerance
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Maximum tolerated dose (g) in oral food challenge at 24 months
Key secondary outcomes
1) Maximum tolerated dose (g) in oral food challenge at 12 months
2) Changes in blood count, total IgE, nut-specific IgE, and TARC at baseline, 6, 12, 18, and 24 months
3) Incidence of systemic allergic reactions, anaphylaxis, adrenaline auto-injector use, and hospitalization-requiring adverse events during treatment
4) Frequency of local symptoms during treatment (oral discomfort, pharyngeal itching, lip swelling, local rash, mild rhinorrhea, sneezing, conjunctival injection)
5) Continuation rate of sublingual immunotherapy at 24 months
6) Achievement status of dose escalation
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Sublingual immunotherapy using nut powder purchased, ground, and packaged by the investigators. The initial dose is 0.01 g administered in the hospital. The powder is measured using the hollow of an EpiPen trainer cap as a mold, placed under the tongue for 2 minutes, and then swallowed. After safety confirmation, participants continue once-daily administration at home. Dose escalation is considered at approximately 2-month outpatient visits according to the following steps: 0.01 g, 0.02 g, 0.05 g, 0.10 g, 0.15 g, and 0.20 g. For doses of 0.02 g or higher, powder measured multiple times is combined into a single dose and administered at once. The intervention period is up to 24 months.
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 | years-old | <= |
Age-upper limit
| 13 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Children aged 5 years to under 13 years
2) Suspected immediate-type allergy to nuts and positive serum specific IgE (ImmunoCAP, >=0.35 UA/mL)
3) Written informed consent from parents/guardians and assent from the child when applicable
4) Judged medically appropriate for participation by the treating physician
Key exclusion criteria
1) Poorly controlled asthma (visit for asthma or steroid use within the past 3 months)
2) Other severe chronic diseases such as heart disease, immunodeficiency, or collagen disease
3) Severe developmental delay or behavioral problems making continuation difficult
4) Participation in another clinical study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Chihaya |
| Middle name | |
| Last name | Imai |
Organization
University of Toyama Hospital
Division name
Department of Pediatrics
Zip code
930-0194
Address
2630 Sugitani, Toyama, Toyama, Japan
TEL
076-434-2315
chihaya@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Shokei |
| Middle name | |
| Last name | Murakami |
Organization
University of Toyama Hospital
Division name
Department of Pediatrics
Zip code
930-0194
Address
2630 Sugitani, Toyama, Toyama, Japan
TEL
076-434-2315
Homepage URL
shok0207@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Departmental research funds, Department of Pediatrics, University of Toyama Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee for Clinical and Epidemiological Research, University of Toyama
Address
2630 Sugitani, Toyama, Toyama, Japan
Tel
076-415-8857
kenrinri@adm.u-toyama.ac.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 | 07 | 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 | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2029 | Year | 05 | Month | 06 | 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 | 05 | Month | 07 | Day |
Last modified on
| 2026 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070339
