Multicenter prospective cohort study on the prognosis of children with Acute Food protein-induced enterocolitis syndrome (FPIES) provoked by egg yolk

Multicenter prospective cohort study on the prognosis of children with Acute Food protein-induced enterocolitis syndrome (FPIES) provoked by egg yolk - Multicenter prospective cohort study on the prognosis of children with Acute Food protein-induced enterocolitis syndrome (FPIES) provoked by egg yolk

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000047990

Enrollment

Registered

2022-06-08

Start date

2022-06-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Food protein-induced enterocolitis syndrome (FPIES) provoked by egg yolk

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Acquired resistance to egg yolk Acute FPIES for 3 years from the time of study registration	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactHiroki Masumi

Kindai University Faculty of Medicine Pediatrics

hirokimasumi@med.kindai.ac.jp072-366-0221

Outcome results