UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057335 |
|---|---|
| Receipt number | R000065461 |
| Scientific Title | Fixed low-dose antigen intake for tree nut allergies; an open-label, randomized trial |
| Date of disclosure of the study information | 2025/03/19 |
| Last modified on | 2025/03/19 11:30:25 |
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Basic information
Public title
Fixed low-dose antigen intake for tree nut allergies; an open-label, randomized trial
Acronym
Fixed low-dose antigen intake for tree nut allergies
Scientific Title
Fixed low-dose antigen intake for tree nut allergies; an open-label, randomized trial
Scientific Title:Acronym
Fixed low-dose antigen intake for tree nut allergies
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of fixed low-dose antigen intake for tree nut allergies
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients with a negative oral food challenge results six months after starting intake (or elimination)
Key secondary outcomes
Safety and continuity of antigen intake
The threshold dose of antigen and severity of allergic reaction provoked in OFCs.
The shift of laboratory data (e.g. specific IgE titer)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Fixed low-dose antigen intake.
Ingest antigen every day according to the protocol.
Interventions/Control_2
Elimination diet
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
| 2 | years-old | < |
Age-upper limit
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Children with severe food allergies, such as tree nut or peanut allergies, who are capable of possessing and managing an epinephrine auto-injector.
Key exclusion criteria
Patients with severe comorbidity
Patients with uncontrollable asthma or atopic dermatitis
Patients whose parents can not manage adrenalin autoinjector
Patients who required epinephrine (excluding inhalation) during the entry oral food challenge or who ended with only mild subjective symptoms.
Patients deemed unsuitable by the physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Katsumasa |
| Middle name | |
| Last name | Kitamura |
Organization
Aichi Children's Health and Medical Center
Division name
Allergy and Immunology Center, Department of Allergy
Zip code
474-8710
Address
7-426, Morioka-cho, Obu, Aichi, Japan
TEL
0562-43-0500
katsumasa_kitamura@sk00106.achmc.pref.aichi.jp
Public contact
Name of contact person
| 1st name | Katsumasa |
| Middle name | |
| Last name | Kitamura |
Organization
Aichi Children's Health and Medical Center
Division name
Allergy and Immunology Center, Department of Allergy
Zip code
474-8710
Address
7-426, Morioka-cho, Obu, Aichi, Japan
TEL
0562-43-0500
Homepage URL
katsumasa_kitamura@sk00106.achmc.pref.aichi.jp
Sponsor or person
Institute
Aichi Children's Health and Medical Center
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Aichi Children's Health and Medical Center
Address
7-426, Morioka-cho, Obu, Aichi, Japan
Tel
0562-43-0500
katsumasa_kitamura@sk00106.achmc.pref.aichi.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
| 2025 | Year | 03 | Month | 19 | 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 | 01 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 03 | Month | 19 | Day |
Last modified on
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065461
