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Observational study on the safety of consuming heat-processed seafood among patients with Anisakis allergy.

Observational study on the safety of consuming heat-processed seafood among patients with Anisakis allergy. - Consumption of heat-processed seafood in patients with Anisakis allergy.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000056542
Enrollment
40
Registered
2024-12-25
Start date
2025-02-01
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

Anisakis allergy

Interventions

None listed

Sponsors

NHO Sagamihara National Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Within the two years prior to registration, the person has a history of systemic immediate allergic symptoms after consuming fish or squid (if two or more of the following symptoms occur - skin/mucous membrane symptoms, digestive symptoms, respiratory symptoms, cardiovascular symptoms - then it is considered systemic. In the case of heat-processed food, symptoms begin within two hours of eating, and in the case of raw food, symptoms begin within 24 hours of consumption) (2) Specific IgE antibody titer for anisakis of 0.70 UA/mL or higher in a blood test taken within the year prior to registration (3) As the cause of the symptoms described in criterion (1), allergy to food itself, including seafood, can be ruled out by IgE testing, etc. (4) All systemic allergic symptoms that have occurred in relation to the consumption of fish or squid have occurred after eating raw fish or squid (including food that has been pickled in vinegar or salted). (5) 20 years of age or older (6) Mentally responsible and able to communicate verbally

Exclusion criteria

Exclusion criteria: (1) Those who cannot agree to a one-year diary survey and regular outpatient visits (2) Those with active chronic spontaneous urticaria, systemic food allergy due to causes other than the target condition, or active multiple chemical sensitivity (3) Patients with active chronic respiratory diseases other than asthma, active cardiac disease and/or renal disease, autoimmune diseases requiring pharmacologic treatment, inflammatory bowel disease, malignant neoplasms, or severe allergic skin diseases (4) Patients who are expected to take regular doses of a histamine H1 receptor antagonist for almost the entire observation period, or who are expected to use omalizumab or dupilumab at least once during the observation period (5) Other cases judged to be ineligible

Design outcomes

Primary

MeasureTime frame
The incidence of anaphylaxis (number of occurrences/number of meals) after eating heat-processed fish or squid in a food diary is less than 1% or 1% or more.

Secondary

MeasureTime frame
Disease-related quality of life score at the time of registration Change in disease-related quality of life score between the time of registration and one year later Incidence of immediate allergic symptoms associated with food intake of the three seafood intake categories (no intake, intake of cooked/processed seafood, intake of raw seafood) in the food diary. Incidence of immediate allergic symptoms in the food diary Incidence of immediate allergic symptoms in the food diary in the survival analysis model Cluster analysis based on dietary intake patterns in the diary Cumulative incidence of anaphylaxis in the food diary Improvement in disease-related quality of life

Countries

Japan

Contacts

Public ContactYuma Fukutomi

NHO Sagamihara National Hospital Division of Clinical Research Promotion, Clinical Research Center for Allergy and Rheumatology

fukutomi.yuma.da@mail.hosp.go.jp042-742-8311

Outcome results

None listed

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