Randomized trial of preventing complete avoidance in challenge-proven severe egg-allergic infants

Randomized trial of preventing complete avoidance in challenge-proven severe egg-allergic infants - Randomized trial of preventing complete avoidance in challenge-proven severe egg-allergic infants

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027332

Enrollment

Registered

2017-05-16

Start date

2017-05-16

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

Hen&#39

Interventions

Daily intake of heated hen&#39

s egg powder for 6 months. The dose of intake for the initial 1 month is 0.2g of heated hen&#39

egg powder (50mg of egg protein). After 1 month, the intake amount is gradually increased towards the target dose of 1g of heated hen&#39

s egg powder (250mg of egg protein). Daily intake of placebo powder for 6 months. The dose of intake for the initial 1 month is 0.2g of placebo powder. After 1 month, the intake amount is gradually

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Positive oral food challenge to 1/32 of heated hen's egg (250mg of egg protein) within 3 months of initiation of the trial. Capable of consuming 1/160 of heated hen's egg (50mg of egg protein) without allergic symptoms.

Exclusion criteria

Exclusion criteria: Severe allergic symptoms or symptoms requiring the use of adrenaline during the oral food challenge to 1/32 of heated hen's egg (250mg of egg protein). Regular intake of hen's egg before initiation of trial. Severe (uncontrolled) atopic dermatitis before intiation of trial. Two or more hospitalizations due to wheezing episodes in the previous 6 months before initiation of trial

Design outcomes

Primary

Measure	Time frame
Proportion of patients desensitized to 1/8 of heated hen's egg after 6 months, confirmed with a double-blind, placebo-controlled food challenge (DBPCFC)	—

Secondary

Measure	Time frame
Frequency and severity of adverse events at home during the trial. Changes in egg white and ovomucoid specific IgE, IgG, IgG4 measured before trial and after 6 and 12 months of the trial. Changes in skin prick test results tested before trial and after 6 and 12 months of the trial. Sustained unresponsiveness to 1/2 of heated hen's egg within 1.5 years of initiation of the trial.	—

Countries

Japan

Contacts

Public ContactMakoto Nishino

National Hospital Organization Sagamihara National Hospital Department of Pediatrics

precastudy@gmail.com042-742-8311

Outcome results

None listed

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