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Safety and Efficacy of slow low-dose oral immunotherapy Shimane version for patients with positive low-dose oral food challenge

Safety and Efficacy of slow low-dose oral immunotherapy Shimane version for patients with positive low-dose oral food challenge - Shimane-SLOIT 2022

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049359
Enrollment
200
Registered
2022-10-28
Start date
2022-11-01
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

food allergy

Interventions

Slow low dose oral immunotherapy (ingesting hen&#39
s egg, cow milk and wheat protein everyday with increasing the dose at home whenever they could for every 30 consecutive intakes without obviouslious allergic symptoms) complete avoidance of antigen

Sponsors

Department of Pediatrics, Shimane University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Diagnosed with FA of either egg, milk, or wheat. 2) Less than 16 years of age at the time of consent. 3) Weighs 15 kg or more and is able to possess epinephrine autoinjector. 4) Positive oral food challenge with less than 3.5 g of boiled egg white or udon noodles or less than 3.5 mL of cow's milk. 5) Written consent to participate in the study has been obtained from the parents.

Exclusion criteria

Exclusion criteria: 1) severe anaphylaxis induced by oral food challenge 2) uncontrolled bronchial asthma or atopic dermatitis 3) Has malignancy, autoimmune disease, immunodeficiency, severe cardiac disease, or chronic infectious disease 4) Consecutive use of systemic corticosteroids or anticancer agents 5) Undergoing other immunotherapy

Design outcomes

Primary

MeasureTime frame
The result of oral food challenges after one-year of Shimane-SLOIT

Secondary

MeasureTime frame
safety of Shimane-SLOIT

Countries

Japan

Contacts

Public ContactSeiya Masukane

Shimane University School of Medicine Department of Pediatrics

masukane@med.shimane-u.ac.jp0853-20-2220

Outcome results

None listed

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