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Randomized trial of ingestion method of oral immunotherapy for severe food allergic patients

Randomized trial of ingestion method of oral immunotherapy for severe food allergic patients - Randomized trial of ingestion method of oral immunotherapy for severe food allergic patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000033345
Enrollment
48
Registered
2018-07-10
Start date
2018-07-17
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

Oral immunotherapy with a target dose of middle-dose Oral immunotherapy with ingestion of low-dose

Sponsors

National Hospital Organization Sagamihara National Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who performed low-dose oral immunotherapy (target dose of one eight of whole egg, 3 ml of cow's milk, 2g of Udon (Japanese wheat noodles), 0.5g of whole peanut or 0.5g of nut) for 12 months or more. Patients who achieved desensitization to low-dose and have been asymptomatic for 3 months or more. Patients who failed middle-dose oral food challenge after 2 weeks of complete avoidance.

Exclusion criteria

Exclusion criteria: Decision of ineligibility by a physician

Design outcomes

Primary

MeasureTime frame
Sustained unresponsiveness to middle-dose after 12 months. Middle dose was defined as "half of a whole egg, 25 ml of cow's milk, 25g of Udon, 3g of peanut or 3g of nut".

Secondary

MeasureTime frame
Changes of specific IgE, IgG, IgG4 Frequency of adverse reactions The rate of sustained unresponsiveness to middle-dose after 5 years from start of OIT.

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