Efficacy of inducing tolerance by extremely very low dose OFC in patients with severe hen's egg, cow's milk, and wheat allergy patients

Efficacy of inducing tolerance by extremely very low dose OFC in patients with severe hen's egg, cow's milk, and wheat allergy patients - Efficacy of inducing tolerance by extremely very low dose oral food challenge in patients with severe hen's egg, cow's milk, and wheat allergy patients

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1030250461

Enrollment

300

Registered

2025-10-28

Start date

2025-10-28

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

Food allergy patients with hen's egg, cow's milk, and wheat. food allergy, oral food challenge, hen's egg, cow's milk, wheat

Interventions

Subjects are randomly divided into two groups. a Extremely very low dose group and a very low dose group. Extremely very low dose group Extremely very low doses (hen's egg 1/250 of whole egg, milk 0.

Eligibility

Inclusion criteria

Inclusion criteria: Patients who had obvious allergic symptoms induced in very low dose oral food challenge test (1/100 of heated hen's egg, 0.3 mL of cow's milk, 1 g of wheat (udon)).

Exclusion criteria

Exclusion criteria: 1) Patients who have not completely elimination the causative food 2) Patients suffering from severe liver/kidney disorders or heart disease 3) Patients judged to be ineligible by the judgment of the research Doctor

Design outcomes

Primary

Measure	Time frame
Full dose oral food challenge test negative (acquired tolerance) rate between the two groups 10, 25, and 40 months after the start of the study	—

Secondary

Measure	Time frame
Comparison of hen's egg, milk, and wheat intake thresholds between the two groups 10, 25, and 40 months after the start of the study Comparison of blood test result trends (serum total IgE level, egg/milk/wheat-related specific IgE level, and IgG4, IgE affinity, serum SCCA2 level) Comparison of skin prick test result trends Comparison of each oral food challenge positive risk factor in 2 groups Comparison of thresholds for each starting age in the two groups	—

Measure

Time frame

Comparison of hen's egg, milk, and wheat intake thresholds between the two groups 10, 25, and 40 months after the start of the study Comparison of blood test result trends (serum total IgE level, egg/milk/wheat-related specific IgE level, and IgG4, IgE affinity, serum SCCA2 level) Comparison of skin prick test result trends Comparison of each oral food challenge positive risk factor in 2 groups Comparison of thresholds for each starting age in the two groups

—

Contacts

Public ContactKosei Yamashita

Showa University Hospital

meko11115@med.showa-u.ac.jp+81-3-3784-8565

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026