Anisakis allergy
Conditions
Interventions
Test powder: Each sachet contains a total weight of 500 mg, comprising 25 mg of heat-treated Anisakis powder and 475 mg of dextrin. Placebo powder: Each sachet contains 500 mg of dextrin. Both powde
Sponsors
NHO Sagamihara National Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed at the Department of Allergy, Sagamihara National Hospital with immediate-type allergy to Anisakis, or suspected immediate-type Anisakis allergy. 2. Serum Anisakis-specific IgE level of 0.35 Ua/mL or higher (ImmunoCAP assay) on a blood test performed within 2 years prior to obtaining informed consent. 3. Willing to undergo an oral challenge test with heat-treated Anisakis powder at the patient's own request. 4. Aged 20 years or older. 5. Able to provide written informed consent after receiving a full explanation of the study, including its risks and benefits. 6. Judged by the attending physician to be in good general condition on the day of the challenge test.
Exclusion criteria
Exclusion criteria: 1. Severe or poorly controlled asthma (e.g., a moderate or more severe exacerbation within the past month, low FEV1, etc.). 2. Serious underlying cardiovascular disease (e.g., severe arrhythmia, heart failure, recent myocardial infarction, etc.). 3. A history of extremely severe anaphylaxis such that the attending physician judges the oral challenge to be high risk. 4. Pregnant or breastfeeding women. 5. Patients who cannot discontinue medications that may interfere with anaphylaxis management, such as beta-blockers or ACE inhibitors. 6. Patients judged to have difficulty maintaining understanding of and ongoing consent for study participation due to psychiatric illness or other conditions. 7. Any other individuals deemed inappropriate for participation in this study by the treating physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence or absence of elicited symptoms in each individual case | — |
Countries
Japan
Contacts
Public ContactYuma Fukutomi
NHO Sagamihara National Hospital Clinical Research Center for Allergy and Rheumatology
Outcome results
None listed