UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046617 |
|---|---|
| Receipt number | R000053180 |
| Scientific Title | Study on Oral Food challenge with Heated hen's Egg Powder for Food Protein-Induced Enterocolitis Caused by egg yolk |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2022/01/14 10:38:04 |
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Basic information
Public title
Study on Oral Food challenge with Heated hen's Egg Powder for Food Protein-Induced Enterocolitis Caused by egg yolk
Acronym
TAMAKONA for sFPIES
Scientific Title
Study on Oral Food challenge with Heated hen's Egg Powder for Food Protein-Induced Enterocolitis Caused by egg yolk
Scientific Title:Acronym
TAMAKONA for sFPIES
Region
| Japan |
Condition
Condition
Food Protein Induced Enterocolitis Syndrome
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The most common type of food allergy is immediate allergy, in which skin and respiratory symptoms are observed within an hour of ingestion of the causative food.
On the other hand, there is a type of food protein-induced enterocolitis (FPIES) in which gastrointestinal symptoms are mainly observed within a few hours after ingestion of the causative food, and it is known that the number of patients has been increasing in recent years.
At present, the standard treatment is to teach the elimination of the causative food, and to confirm the acquisition of tolerance by conducting an oral food challenge (OFC) test.
As with immediate food allergy, it is known that tolerance is acquired during the growth process, but there are also cases of prolonged tolerance. The clinical features of FPIES are much less clear than those of immediate food allergy. It is still unclear what components of the food react with the protein and what mechanisms are used to develop tolerance.
In the OFC for immediate type food allergy to hen's eggs, the use of dried cooked whole egg powder, which is commercially available as a standardized antigen, is recommended in the guidelines. There is no standard guideline for OFC for FPIES, and it varies from institution to institution.
In this study, we will evaluate the efficacy of OFC using dried and heated whole egg powder.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In patients with solid FPIES induced by egg yolk, whether dry cooked whole egg powder also induces symptoms
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Food |
Interventions/Control_1
Patients will take one piece of heat-dried whole egg powder (Tamakona(R)) in the oral food challenge test.
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 | months-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have been diagnosed with solid FPIES due to egg yolk at our hospital and do not have an immediate food allergy to heated hen's egg white
Key exclusion criteria
Patients with unconfirmed egg white intake
Patients with complications of immediate food allergy to egg white
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Baba |
Organization
Juntendo University Shizuoka Hospital
Division name
Department of Pediatrics
Zip code
4102295
Address
1129 Nagaoka, Izunokuni, Shizuoka
TEL
0559483111
youbaba@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Baba |
Organization
Juntendo University Shizuoka Hospital
Division name
Department of Pediatrics
Zip code
4102295
Address
1129 Nagaoka, Izunokuni, Shizuoka
TEL
0559483111
Homepage URL
youbaba@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Juntendo University Faculty of Medicine
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
Tel
0338133111
youbaba@juntendo.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
| 2022 | Year | 02 | 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
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2022 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 01 | Month | 12 | Day |
Last modified on
| 2022 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053180
