UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060693 |
|---|---|
| Receipt number | R000069423 |
| Scientific Title | Frequency and Intake Study after Post-Egg Oral Food Challenge |
| Date of disclosure of the study information | 2026/02/17 |
| Last modified on | 2026/02/17 12:01:51 |
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Basic information
Public title
Frequency and Intake Study after Post-Egg Oral Food Challenge
Acronym
FINE-OFC
Scientific Title
Frequency and Intake Study after Post-Egg Oral Food Challenge
Scientific Title:Acronym
FINE-OFC
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of frequent low-dose versus standard-dose home intake of heated egg by evaluating symptom occurrence at 1/2 egg OFC after 6 months in children who tested negative for 1/8 egg OFC.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Symptom occurrence rate at oral food challenge with 1/2 heated hen's egg at 6 months
Key secondary outcomes
1. Anaphylaxis incidence rate at the 6-month challenge test
2. Symptom occurrence rate during the home-consumption period
3. Change in egg white-specific IgE levels (baseline, 6 months)
4. Change in ovomucoid-specific IgE levels (baseline, 6 months)
5. Egg white/ovomucoid-specific IgG4 levels (6 months)
6. Compliance rate with home consumption (evaluated via patient diary)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Tamakona(R) 250 three times per week for 6 months.
Interventions/Control_2
Tamakona(R) 750 once per week for 6 months.
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
| Not applicable |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with a history of immediate-type allergic reactions to hen's egg
Patients who had a negative oral food challenge (OFC) to 1/8 of a heated hen's egg at our hospital OR Patients who had a positive OFC to 1/2 of a heated whole egg at our hospital
Patients (or their guardians) who provided written informed consent for participation in the study
Key exclusion criteria
Patients with severe comorbidities (e.g., severe asthma, cardiac disease)
Patients scheduled to receive other allergy treatments (e.g., oral immunotherapy) during the study period
Patients deemed inappropriate for study participation by the principal investigator
Target sample size
104
Research contact person
Name of lead principal investigator
| 1st name | Kyohei |
| Middle name | |
| Last name | Takahashi |
Organization
NHO Sagamihara National Hospital
Division name
Division of Epidemiological Statistics
Zip code
2520392
Address
Sakura-dai 18-1, Minami-ward, Sagamihara city, Kanagawa pref.
TEL
042-742-8311
fineofc@kcrt.net
Public contact
Name of contact person
| 1st name | Kyohei |
| Middle name | |
| Last name | Takahashi |
Organization
NHO Sagamihara National Hospital
Division name
Pediatrics
Zip code
2520392
Address
Sakura-dai 18-1, Minami-ward, Sagamihara city, Kanagawa pref.
TEL
042-742-8311
Homepage URL
fineofc@kcrt.net
Sponsor or person
Institute
NHO Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
The Nipponham Foundation for the Future of Food
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Sagamihara Hospital Ethics Committee
Address
Sakura-dai 18-1, Minami-ward, Sagamihara city, Kanagawa pref.
Tel
042-742-8311
222-rinri@mail.hosp.go.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 | 02 | Month | 17 | 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
| 2025 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2030 | 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 | 02 | Month | 17 | Day |
Last modified on
| 2026 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069423
