food allergy
Conditions
Interventions
The target amount of ingestion, regarding tolerance acquisition, is defined one thirty-seconds hen'
s egg, 3ml of cow'
s milk, 2g of Japanese Udon noodles, and 0.5g of peanut. The subjects are asked to take a small amount of their causative food at inpatient department, and it is built up to target amount gradually d
Sponsors
National Hospital Organization Sagamihara National Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Because description of key inclusion criteria was insufficient, we have revised it as follows. The patients who visit to our hospital and exert objective symptoms based on the oral food challenge with one of the following food products are included to this study; 1/32 of a heated whole egg (194mg of egg protein), 3ml of cow's milk (102mg of milk protein), 2g of Udon (53mg of wheat protein) or 0.5g of whole peanut (133mg of peanut protein). Objective symptoms is based as on the anaphylaxis guideline by Japanese Society of Allergology (Yanagida N. et al Allergol Int 2016, Ebisawa M. et al Allergol Int 2017.)
Exclusion criteria
Exclusion criteria: The subject who has not-well treated atopic dermatitis, bronchial asthma, or any underlying disease. The subject who is not appropriate for oral immunotherapy, judged by medical doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Because description of primary outcome was insufficient, we have revised it as follows. The rate of sustained unresponsiveness* to middle-dose** after 1 year *Sustained unresponsiveness is defined as "when patients passed the OFC of middle-dose after the complete avoidance for 2 weeks". **Middle-dose is defined as "half of a whole egg, 25 ml of cow's milk, 15g of Udon, 3g of peanut". | — |
Secondary
| Measure | Time frame |
|---|---|
| Because description of key secondary outcomes was insufficient, we have revised it as follows. 1. Frequency of adverse reactions 2. The rate of sustained unresponsiveness* to middle-dose** or full-dose*** after 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, and 10 years from start of OIT. 3. Changes of specific IgE, IgG and IgG4 4. Comparison with rush oral immunotherapy (adverse reactions, the rate of sustained unresponsiveness to middle-dose and full-dose, and changes of specific IgE) after 1 year, 2 years, 3 years, 4 years 5 years, 6 years, 7 years, 8 years, 9 years, and 10 years from start of OIT. *Sustained unresponsiveness is defined as "when patients passed the OFC of middle-dose or full-dose after the complete avoidance for 2 weeks". **Middle dose is defined as "half of a whole egg, 25 ml of cow's milk, 15g of Udon, 3g of peanut". ***Full dose is defined as "whole egg, 50-200 ml of cow's milk, 50-200g of Udon and 5-10g of peanuts". | — |
Countries
Japan
Contacts
Public ContactNoriyuki Yanagida
National Hospital Organization Sagamihara National Hospital Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Outcome results
None listed