Effect of oral immunotherapy in preschool children with milk allergy; Trial for the detection of prospective markers for the effectiveness

Effect of oral immunotherapy in preschool children with milk allergy; Trial for the detection of prospective markers for the effectiveness - ORIMA study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005784

Enrollment

Registered

2011-07-05

Start date

2011-07-01

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

Milk Allergy

Interventions

Oral immunotherapy (cow milk) obserbation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Those who show positive reaction (over Grade 1) for the double blinded placebo controlled milk challenge test. 2. Those who show positive milk-specific IgE (> 0.69 UA/mL). 3. Those who can visit our hosputal within 30 minutes at emergency.

Exclusion criteria

Exclusion criteria: 1. Those who have a past history with life threatning milk allergy (anaphylaxy). 2. Uncontrolled asthma. 3. Uncontrolled atopic dermatitis. 4. soy allergy

Design outcomes

Primary

Measure	Time frame
The ratio of subjects showing negative reaction for milk provocation test (100 mL) after 1-year intervention.	—

Secondary

Measure	Time frame
1. Changes in threshold at milk provocation test 2. Changes in skin reactions for prick test 3. Peripheral eosinophil cell count 4. Changes in milk specific IgE, IgG, IgG4 levels	—

Countries

Japan

Outcome results

None listed

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