UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049790 |
|---|---|
| Receipt number | R000056709 |
| Scientific Title | Effect of Omalizumab therapy for food allergy in children with severe pollen allergy |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2022/12/15 12:00:32 |
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Basic information
Public title
Effect of Omalizumab therapy for food allergy in children with severe pollen allergy
Acronym
Effect of Omalizumab therapy for food allergy in children with severe pollen allergy
Scientific Title
Effect of Omalizumab therapy for food allergy in children with severe pollen allergy
Scientific Title:Acronym
Effect of Omalizumab therapy for food allergy in children with severe pollen allergy
Region
| Japan |
Condition
Condition
food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the effect of Omalizumab therapy on food allergy in children with severe pollen allergy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of thresfold dose of oral food challenge by 12 week's omalizumab therapy for children with severe pollen allergy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 12 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children met inclusion criteria of Omalizumab therapy for severe pollen allergy
Children with no improvement by standard food allergy therapy
Key exclusion criteria
Children with severe atopic dermatitis and severe bronchial asthma
Children those are given by beta-blocker
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Shoihciro |
| Middle name | |
| Last name | Taniuchi |
Organization
Takatsuki General Hospital
Division name
Pediatrics
Zip code
569-1192
Address
1-3-13, Kosobe-cho, Takatsuki city
TEL
072-681-3801
taniuchishoichiro@gmail.com
Public contact
Name of contact person
| 1st name | Shoihciro |
| Middle name | |
| Last name | Taniuchi |
Organization
Takatsuki General Hospital
Division name
Pediatrics
Zip code
569-1192
Address
1-3-13, Kosobe-cho, Takatsuki city
TEL
072-681-3801
Homepage URL
taniuchishoichiro@gmail.com
Sponsor or person
Institute
Takatsuki General Hospital
Institute
Department
Personal name
Funding Source
Organization
Takatsuki General Hosipital
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
Takatsuki General Hospital
Address
1-3-13, Kosobe-cho, Takatsuki-city
Tel
072-681-3801
taniuchishoichiro@gmail.com
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 | 04 | 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
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
Evaluation of Omalizumab therapy before and after the treatment (12 weeks) using measurement of total IgE, specific food and pollen allergen related s-IgE, DCP specific IgE , 1/IC50 and food allergen specific IgG4
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation of the 12 week's Omalizumab therapy using measurement of threshold dose of oral food challenge, total IgE, food and pollen specific immunocap IgE, DCP IgE, DCP IgG4, skin prick test and 1/IC50
Management information
Registered date
| 2022 | Year | 12 | Month | 15 | Day |
Last modified on
| 2022 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056709
