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A randomized controlled trial of low-dose oral immunotherapy for preschool-aged children with food allergy

A randomized controlled trial of low-dose oral immunotherapy for preschool-aged children with food allergy - Low-dose oral immunotherapy for preschool-aged children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000041637
Enrollment
216
Registered
2020-09-02
Start date
2020-09-03
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 target amount of ingestion is defined as 1/25 of a heated whole hen&#39
s egg (250mg of hen&#39
s egg protein), 3ml of cow&#39
s milk, 2g of udon, 0.5g of peanut, walnut, cashew, hazelnut, almond, and macadamia nut. The subjects are asked to take a small amount of their causative food at the inpatient department. The amount

Sponsors

National Hospital Organization Sagamihara National Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who visited our hospital and exhibited objective symptoms based on the oral food challenge with one of the following food products are included in this study; 1/25 of a heated whole hen's egg (250mg of hen's egg protein), 3ml of milk, and 2g of udon, 0.5g of peanut, walnut, cashew, hazelnut, almond, and macadamia nut. Objective symptoms were based on the Japanese Society of Allergology anaphylaxis guidelines (Yanagida N. et al. Allergol Int 2016, Ebisawa M. et al. Allergol Int 2017.). *Walnut, cashew, hazelnut, almond, and macadamia nut were added on November 6, 2020, before enrollment of first patient.

Exclusion criteria

Exclusion criteria: The subject who has poorly treated atopic dermatitis and bronchial asthma. The subject suspected with Food-protein induced enterocolitis syndrome. The subject whose body weight is less than 10 kg. The subject who seems inappropriate candidate for oral immunotherapy as judged by a medical doctor.

Design outcomes

Primary

MeasureTime frame
The rate of negative oral food challenge to the low-dose* after 1 year *The low-dose is defined as"1/25 of a heated whole hen's egg (250mg of hen's egg protein), 3ml of cow's milk, 2g of udon, 0.5g of peanut, walnut, cashew, hazelnut, almond, and macadamia nut". Walnut, cashew, hazelnut, almond, and macadamia nut were added on November 6, 2020, before enrollment of first patient.

Countries

Japan

Contacts

Public ContactKen-ichi Nagakura

National Hospital Organization Sagamihara National Hospital Clinical Research Center for Allergy and Rheumatology

k.nagakura@foodallergy.jp042-742-8311

Outcome results

None listed

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