Non-IgE-mediated gastrointestinal food allergy
Conditions
Interventions
None listed
Sponsors
National Center for Child Health and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children who have visited one of the participating research medical institutions and, at the time of registration, were either diagnosed with or suspected of having a gastrointestinal food allergy by a physician. 2. The onset of the condition must have occurred before the child's second birthday (i.e., under 2 years of age). 3. At the time of registration, the child must be younger than 3 years of age (i.e., before their third birthday). 4. Informed consent has been obtained from the child's guardians.
Exclusion criteria
Exclusion criteria: 1. Participants whose legal guardians are unable to understand Japanese. 2. Patients for whom the collaborating research physician has determined that it would be best not to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Data Collection Schedule: Participants will be assessed at baseline (registration), at 6 months post-registration, at 1 year post-registration, and then annually until they reach 5 years of age (with the possibility of extension). Primary Outcome Measures: Parental Questionnaire: Assessment of symptoms, disease control status, treatment details, dietary intake, and the presence of any new allergic disorders. Physician Case Report Form: Collection of clinical diagnosis (e.g., acute FPIES, chronic FPIES, FPE, FPIAP, or others), suspected trigger foods, anthropometric measurements, comorbid allergic disorders, blood test results, oral food challenge outcomes, and findings from endoscopic and pathological examinations. | — |
Countries
Japan
Contacts
Public ContactIchiro Nomura
National Center for Child Health and Development Division of Eosinophilic Gastrointestinal Disorders
Outcome results
None listed