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Sublingual immunotherapy using imported birch pollen extract for injection

Sublingual immunotherapy using imported birch pollen extract for injection - Sublingual immunotherapy using imported birch pollen extract for injection

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024376
Enrollment
10
Registered
2016-12-01
Start date
2016-12-01
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

oral allergy syndrome (OAS)

Interventions

Because there is no allergen extract of birch pollen approved for use in therapy at the moment in Japan, we use Birch Mix for injection made by ALK-Abello (USA). We have obtained certification from th

Sponsors

Kanagawa Children's Medical Center Department of Allergy
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Persons who have been sensitized with birch pollen (specific IgE>0.7 UA/mL, ImmunoCAP) and suffer from OAS symptoms by ingestion of fruits or vegetables.

Exclusion criteria

Exclusion criteria: Severe immune abnormality or immunodeficiency, malignancy, severe mental disorder, use of beta blocker, poor compliance, uncontrolled asthma, use of cardiovascular drugs increasing a side effect of the adrenaline, pregnancy, etc..

Design outcomes

Primary

MeasureTime frame
The primary outcome is the change in OAS symptoms after the treatment, which is evaluated by oral food challenge test with numerical rating scale (NRS) before and at some time points after the treatment.

Secondary

MeasureTime frame
We also measure nonspecific IgE, specific IgE and specific IgG4 to birch pollen and causative foods before and after the treatment.

Countries

Japan

Contacts

Public ContactShuntaro Tsumagari

Kanagawa Children's Medical Center Department of Allergy

stsumagari@kcmc.jp045-711-2351

Outcome results

None listed

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