UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056542 |
|---|---|
| Receipt number | R000064611 |
| Scientific Title | Observational study on the safety of consuming heat-processed seafood among patients with Anisakis allergy. |
| Date of disclosure of the study information | 2024/12/25 |
| Last modified on | 2026/03/27 15:28:38 |
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Basic information
Public title
Observational study on the safety of consuming heat-processed seafood among patients with Anisakis allergy.
Acronym
Consumption of heat-processed seafood in patients with Anisakis allergy.
Scientific Title
Observational study on the safety of consuming heat-processed seafood among patients with Anisakis allergy.
Scientific Title:Acronym
Consumption of heat-processed seafood in patients with Anisakis allergy.
Region
| Japan |
Condition
Condition
Anisakis allergy
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to confirm that the risk of anaphylaxis being induced by the consumption of heat-processed seafood is extremely low by asking patients with anisakis allergy to keep a diary of the contents of the food they consume in a prospective manner.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
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.
Key secondary outcomes
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | > |
Gender
Male and Female
Key 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
Key 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
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuma |
| Middle name | |
| Last name | Fukutomi |
Organization
NHO Sagamihara National Hospital
Division name
Division of Clinical Research Promotion, Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1 Sakuradai Minami-ku Sagamihara Kanagawa Japan
TEL
042-742-8311
fukutomi.yuma.da@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Yuma |
| Middle name | |
| Last name | Fukutomi |
Organization
NHO Sagamihara National Hospital
Division name
Division of Clinical Research Promotion, Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1 Sakuradai Minami-ku Sagamihara Kanagawa Japan
TEL
042-742-8311
Homepage URL
fukutomi.yuma.da@mail.hosp.go.jp
Sponsor or person
Institute
NHO Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Review Board for Clinical Trials (Headquarters)
Address
2-5-21 Higashigaoka, Meguro-ku, Tokyo
Tel
03-5712-5050
700-kenkyu@mail.hosp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
During the registration period (from 8 November 2024 to 7 November 2026), we will invite patients with Anisakis allergy who have visited the outpatient department of the medical institution where the research will be conducted and who meet the selection criteria to participate in this study. The study is an observational study that will last for one year and will not involve any intervention. During the observation period, patients will be asked to record in a diary the types of seafood they consume in their daily lives, and also to record in the diary any immediate allergic symptoms they experience. In addition, patients will be asked to visit the outpatient clinic regularly, and the doctor in charge will check and evaluate the contents of the diary at the time of the outpatient visit.
Management information
Registered date
| 2024 | Year | 12 | Month | 23 | Day |
Last modified on
| 2026 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064611
