Efficacy and safety of low-dose oral immunotherapy with heated milk powder in patients with severe milk allergy

Efficacy and safety of low-dose oral immunotherapy with heated milk powder in patients with severe milk allergy - Low dose oral immunotherapy with heated milk powder

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000046749

Enrollment

Registered

2022-01-27

Start date

2022-01-17

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

Interventions

The intervention group will be treated with oral immunotherapy using heated milk powder. During hospitalization, the ingestion of very low dose of heated milk will be started, and the dose which patie

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who have objective symptoms with consumption of 0.2 ml of milk or less before oral immunotherapy

Exclusion criteria

Exclusion criteria: Patients deemed inappropriate to perform oral immunotherapy by the attending physician

Design outcomes

Primary

Measure	Time frame
The frequency of adverse reactions	—

Secondary

Measure	Time frame
(1)Rate of 25ml short-term unresponsiveness (STU) at 1, 2 and 3 years. 25ml STU is defined as a negative result of an oral food challenge (OFC) with 25ml of heated milk and no symptom with consumption of 25ml of heated milk at home thereafter. (2)Changes in blood test values including total IgE, specific IgG and specific IgG4 for milk, casein, alpha-lactalbumin and beta-lactoglobulin (3)Rate of patients with difficulty in increasing dose (4)Adverse reactions by organ, severity of adverse reactions, treatment of adverse reactions and frequency of emergency room visits	—

Measure

Time frame

(1)Rate of 25ml short-term unresponsiveness (STU) at 1, 2 and 3 years. 25ml STU is defined as a negative result of an oral food challenge (OFC) with 25ml of heated milk and no symptom with consumption of 25ml of heated milk at home thereafter. (2)Changes in blood test values including total IgE, specific IgG and specific IgG4 for milk, casein, alpha-lactalbumin and beta-lactoglobulin (3)Rate of patients with difficulty in increasing dose (4)Adverse reactions by organ, severity of adverse reactions, treatment of adverse reactions and frequency of emergency room visits

—

Countries

Japan

Contacts

Public ContactKiyoka Yshimoto

National Hospital Organization Sagamihara National Hospital Department of pediatrics

kiyo.dis55@gmail.com042-742-8311

Outcome results

None listed

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