UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063328 |
|---|---|
| Receipt number | R000072484 |
| Scientific Title | Comparison of 12-Week and 36-Week Maintenance Therapy in Oral Immunotherapy for Wheat Allergy: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/11/01 |
| Last modified on | 2026/10/18 13:18:13 |
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Basic information
Public title
Comparison of 12-Week and 36-Week Maintenance Therapy in Oral Immunotherapy for Wheat Allergy: A Randomized Controlled Trial
Acronym
A Study Comparing Maintenance Durations of Oral Immunotherapy for Wheat Allergy
Scientific Title
Comparison of 12-Week and 36-Week Maintenance Therapy in Oral Immunotherapy for Wheat Allergy: A Randomized Controlled Trial
Scientific Title:Acronym
12-week vs 36-week maintenance OIT for wheat allergy
Region
| Japan |
Condition
Condition
Wheat allergy
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of 12-week and 36-week maintenance therapy in oral immunotherapy for wheat allergy. The primary outcomes are the rates of negative results on the first OFC2 and OFC3 in each group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the rate of a negative result on the first OFC3 between the 12-week and 36-week maintenance groups.
Key secondary outcomes
Comparison of the rate of a negative result on the first OFC2 between the 12-week and 36-week maintenance groups.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Participants undergo wheat oral immunotherapy and receive boiled udon noodles (25 g once daily) for either 12 weeks during the maintenance phase following dose escalation. OFC2 is performed at the end of the maintenance period. Participants with a negative OFC2 undergo OFC3 after the protocol-specified elimination period.
Interventions/Control_2
Participants undergo wheat oral immunotherapy and receive boiled udon noodles (25 g once daily) for 36 weeks during the maintenance phase following dose escalation. OFC2 is performed at the end of the maintenance period. Participants with a negative OFC2 undergo OFC3 after the protocol-specified elimination period.
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
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 2 years or older with wheat allergy.
2. Patients who had a positive oral food challenge (OFC) to less than 25 g of boiled udon noodles.
Key exclusion criteria
Patients who experienced severe anaphylactic symptoms during an OFC. Severe anaphylactic symptoms are defined as requiring multiple doses of epinephrine for anaphylaxis or experiencing anaphylactic shock.
Patients who developed clear allergic symptoms following administration of the initial dose of 0.1 g.
Patients with poorly controlled atopic dermatitis or bronchial asthma.
Patients with severe diseases, or diseases that may affect the study, involving the cardiovascular, neurological, renal or urinary, hepatobiliary, or gastrointestinal systems.
Patients deemed unsuitable for participation in the study by the principal investigator or a sub-investigator for any other reason.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Okada |
Organization
Showa medical university
Division name
pediatrics
Zip code
142--0064
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL
0337848000
y.okada@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Okada |
Organization
Showa medical university
Division name
Pediatrics
Zip code
142--0064
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL
09072222404
Homepage URL
y.okada@med.showa-u.ac.jp
Sponsor or person
Institute
Showa medical university
Institute
Department
Personal name
Funding Source
Organization
none
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
Showa Medical University Ethics Committee
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
Tel
0337848019
zaimu-n@ofc.showa-u.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 | 11 | Month | 01 | 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
44
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | 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 | 10 | Month | 18 | Day |
Last modified on
| 2026 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072484
