UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060563 |
|---|---|
| Receipt number | R000069259 |
| Scientific Title | Oral Food Challenge with Heat-Treated Anisakis Powder in Anisakis Allergy: A Pilot Study |
| Date of disclosure of the study information | 2026/02/10 |
| Last modified on | 2026/02/03 13:24:20 |
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Basic information
Public title
Oral Food Challenge with Heat-Treated Anisakis Powder in Anisakis Allergy: A Pilot Study
Acronym
Oral Food Challenge with Heat-Treated Anisakis Powder in Anisakis Allergy: A Pilot Study
Scientific Title
Oral Food Challenge with Heat-Treated Anisakis Powder in Anisakis Allergy: A Pilot Study
Scientific Title:Acronym
Oral Food Challenge with Heat-Treated Anisakis Powder in Anisakis Allergy: A Pilot Study
Region
| Japan |
Condition
Condition
Anisakis allergy
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To perform an oral challenge test using heat-treated Anisakis powder and evaluate the clinical symptoms elicited by heat-treated Anisakis antigens in patients with confirmed or suspected Anisakis allergy.
Basic objectives2
Others
Basic objectives -Others
Feasibility (pilot) / assessment of elicited symptoms to heat-treated Anisakis antigen
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of elicited symptoms in each individual case
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
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 powders will be suspended or mixed in a vehicle that is easy for the participant to ingest (e.g., a milk-based beverage, yogurt, or an aqueous solution) prior to administration.
Dosing schedule: In a single-blind manner, both the test and placebo powders will be administered orally in two steps in the following order: 1/4 sachet followed by 3/4 sachet. The interval between doses will be at least 60 minutes. Considering individual hypersensitivity, it is permissible to start with a smaller dose before proceeding to the scheduled doses. If symptoms occur, dose escalation will be discontinued. Depending on the circumstances, administration of the placebo powder may be omitted. After each dose, participants will be observed for and the following will be assessed and recorded: cutaneous, respiratory, gastrointestinal, and cardiovascular symptoms. Participants will be observed for at least 2 hours after the final dose. All dosing and observation will be completed within a single day.
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
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Yuma |
| Middle name | |
| Last name | Fukutomi |
Organization
NHO Sagamihara National Hospital
Division name
Clinical Research Center for Allergy and Rheumatology
Zip code
2520392
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
Clinical Research Center for Allergy and Rheumatology
Zip code
2520392
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
JSA WAO 2020 Memorial Research Grant Program
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
The Ethics Committee of Sagamihara National Hospital
Address
18-1, Sakuradai, Minami-ku, Sagamihara, kanagawa, Japan
Tel
042-842-8311
222-rinri@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
Kanagawa
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 10 | 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
| 2025 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 03 | Day |
Last modified on
| 2026 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069259
