Tokyo, Feb. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060563) titled 'Oral Food Challenge with Heat-Treated Anisakis Powder in Anisakis Allergy: A Pilot Study' on Feb. 10.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - NHO Sagamihara National Hospital

Condition: Condition - Anisakis allergy Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 5

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069259

Disclaimer: Curated by HT Syndication.