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A randomized trial of ingestion methods after acquiring tolerance to medium doses with oral immunotherapy for patients with severe food allergy

A randomized trial of ingestion methods after acquiring tolerance to medium doses with oral immunotherapy for patients with severe food allergy - A randomized trial of oral immunotherapy for children with severe food allergy after acquiring tolerance to medium doses

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000044897
Enrollment
40
Registered
2021-07-19
Start date
2021-07-20
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

Gradual increase of ingestion dose Continuing ingestion of middle doses.

Sponsors

National Hospital Organization Sagamihara National Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who acquired tolerance to a middle dose (25 ml of milk or 25 g of udon noodles) more than 1 year after low-dose OIT had been performed.

Exclusion criteria

Exclusion criteria: Decision of ineligibility by a physician

Design outcomes

Primary

MeasureTime frame
The rate of patients who were negative to oral food challenges with with 50 ml milk or 50 g udon after 1 year

Secondary

MeasureTime frame
Changes of specific IgE, IgG, IgG4 Frequency of adverse reactions Rate of drop-out patients

Countries

Japan

Contacts

Public ContactKen-ichi Nagakura

National Hospital Organization Sagamihara National Hospital Department of pediatrics

k.nagakura@foodallergy.jp042-742-8311

Outcome results

None listed

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