UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047990 |
|---|---|
| Receipt number | R000054695 |
| Scientific Title | Multicenter prospective cohort study on the prognosis of children with Acute Food protein-induced enterocolitis syndrome (FPIES) provoked by egg yolk |
| Date of disclosure of the study information | 2022/06/08 |
| Last modified on | 2024/06/10 08:35:51 |
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Basic information
Public title
Multicenter prospective cohort study on the prognosis of children with Acute Food protein-induced enterocolitis syndrome (FPIES) provoked by egg yolk
Acronym
Multicenter prospective cohort study on the prognosis of children with Acute Food protein-induced enterocolitis syndrome (FPIES) provoked by egg yolk
Scientific Title
Multicenter prospective cohort study on the prognosis of children with Acute Food protein-induced enterocolitis syndrome (FPIES) provoked by egg yolk
Scientific Title:Acronym
Multicenter prospective cohort study on the prognosis of children with Acute Food protein-induced enterocolitis syndrome (FPIES) provoked by egg yolk
Region
| Japan |
Condition
Condition
Acute Food protein-induced enterocolitis syndrome (FPIES) provoked by egg yolk
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This is to prospectively observe the Acute Food protein-induced enterocolitis syndrome (FPIES) provoked by egg yolk and investigate the related factors from the resistance acquisition rate after 3 years and the newly acquired samples and information.
Basic objectives2
Others
Basic objectives -Others
Investigate the natural history of egg yolk Acute FPIES
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Acquired resistance to egg yolk Acute FPIES for 3 years from the time of study registration
Key secondary outcomes
1. Comparison of background factors with and without resistance acquisition of egg yolk Acute FPIES
2. Percentage of cases of transition from egg yolk Acute FPIES to immediate food allergy
3. IgE-dependent food allergy other than egg yolk , FPIES other than egg yolk, atopic dermatitis, and bronchial asthma in Egg yolk Acute FPIES cases
4. Changes in blood tests before and after Oral food challenge test (OFC) in OFC-positive cases of egg yolk Acute FPIES (neutrophil count, eosinophil count, TARC)
5. Percentage of cases in which any of egg white, yolk, and ovomucoid-specific IgE antibody titers has increased to 0.35 or higher
6. Comparison of resistance acquisition rate between Atypical FPIES (egg white, yolk, ovomucoid-specific IgE antibody titer 0.35 or higher) and non-IgE-dependent FPIES
7. Positive rate of STEP1 OFC (STEP0 OFC) and STEP2 OFC
8. Correlation between biomarkers (TARC, total IgE value, specific IgE antibody titer, eosinophils, neutrophil count, SPT) and resistance acquisition, severity of induced symptoms
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
| 1 | months-old | <= |
Age-upper limit
| 3 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Children aged 0-2 years at the time of study enrollment
2) Those who have a history of the final induced symptoms of vomiting due to egg yolk ingestion within 3 months from the time of study enrollment
3) Diagnosed as FPIES with egg yolk as an allergen
Key exclusion criteria
1) At the time of research registration,
it was decided to move within one year
2) Those that the caregiver cannot read
Japanese
3) Those with serious gastrointestinal complications or history of surgery
4) Those who cannot take solid foods orally even after 6 months of age
5) Those with congenital immunodeficiency
6) Those using oral immunosuppressive
drugs
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Masumi |
Organization
Kindai University Faculty of Medicine
Division name
Pediatrics
Zip code
589-811
Address
377-2, Osakasayama, Osaka, Japan
TEL
072-366-0221
hirokimasumi@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Masumi |
Organization
Kindai University Faculty of Medicine
Division name
Pediatrics
Zip code
589-8511
Address
377-2, Osakasayama, Osaka, Japan
TEL
072-366-0221
Homepage URL
hirokimasumi@med.kindai.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Kindai University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kindai University Faculty of Medicine
Address
377-2, Osakasayama, Osaka, Japan
Tel
072-366-0221
hirokimasumi@med.kindai.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
市立貝塚病院（大阪府)、大阪警察病院(大阪府)、大阪赤十字病院(大阪府)、大阪はびきの医療センター(大阪府)、関西医科大学病院(大阪府)、神戸市立医療センター中央市民病院(兵庫県)、神戸市立医療センター西市民病院(兵庫県)、国保中央病院(奈良県)、市立奈良病院(奈良県)、市立東大阪医療センター(大阪府)、住友病院(大阪府)、星ヶ丘医療センター(大阪府)、八尾市立病院(大阪府)、大和高田市立病院(奈良県)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 08 | 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
41
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
| 2022 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research design:Multi-institutional joint prospective cohort study
Subjects: 0-2 year old children who visited the research representative facility and the research sharing facility and met the inclusion criteria.
Perform a food oral challenge test of boiled egg yolk every few months after study registration
Survey items: age, gender, nutrition method, allergic family history, results of oral food challenge test, white blood cell count, peripheral blood eosinophil count, total IgE value, hen's egg-specific IgE antibody titer, average wheal diameter of skin prick test, etc.
Management information
Registered date
| 2022 | Year | 06 | Month | 08 | Day |
Last modified on
| 2024 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054695
