UMIN-CTR Clinical Trial

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
Email	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
Email	youbaba@juntendo.ac.jp

Sponsor
Institute	Juntendo University Faculty of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053180