Tokyo, Oct. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059537) titled 'A Multicenter Trial to Evaluate the Efficacy and Safety of Low-Dose Oral Immunotherapy for Walnut Allergy in Children' on Oct. 30.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - National Hospital Organization Sagamihara National Hospital

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

Objective: Narrative objectives1 - Evaluation of the efficacy of oral immunotherapy for patients with walnut allergy Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The follow-up period is 52 weeks.From the start date to 4 weeks, the walnut group begins with 10mg of walnut-containing foods. However, if the pre-existing symptom-eliciting threshold is 10mg or less of walnut, the intake amount begins at half the threshold value and continues. From 4 weeks onward, if asymptomatic for 7 days, the intake amount is increased by one step based on the dosing step table. The dose is increased up to the target amount of 0.4g of walnut (or placebo). After reaching the target amount, intake continues at the same dose. Once the target amount is consumed and the patient remains asymptomatic for 1 month, loratadine administration is discontinued. Interventions/Control_2 - The follow-up period is 52 weeks.The placebo group begins with 10mg of placebo. However, if the pre-existing symptom-eliciting threshold is 10mg or less of walnut, the intake amount begins at half the threshold value. From 4 weeks onward, if asymptomatic for 7 days, the intake amount is increased by one step based on the dosing step table. The dose is increased up to the target amount of 0.4g of placebo. After reaching the target amount, intake continues at the same dose. Once the target amount is consumed and the patient remains asymptomatic for 1 month, loratadine administration is discontinued.

Eligibility: Age-lower limit - 3 years-old

Gender - Male and Female Key inclusion criteria - Patients aged 2 years or older and under 18 years at the time of trial treatment initiation (Day 1) Patients who tested positive for walnut at 0.8g or less (walnut protein amount 116.8mg) by oral food challenge test Patients from whom informed consent for participation in this study has been obtained from their legal guardian or from both the legal guardian and the patient Key exclusion criteria - Patients with poorly controlled bronchial asthma (C-ACT or ACT score of 19 points or less) Patients with severe atopic dermatitis (Eczema Area and Severity Index: EASI score of 16 points or more) Patients undergoing other immunotherapy at the time of trial treatment initiation. However, patients who have been on sublingual immunotherapy (SLIT) or subcutaneous immunotherapy (SCIT) for cedar or dust mites for more than 1 year after initiation and are stable without adverse reactions may be permitted at the discretion of the attending physician. Patients using anti-human IgE antibody preparations, anti-human IL-5 monoclonal antibody preparations, anti-human IL-13 monoclonal antibody preparations, anti-human IL-5 receptor preparations, anti-human IL-4/IL-13 receptor preparations, anti-human IL-31 receptor preparations, anti-human TSLP monoclonal antibody preparations, or JAK inhibitors (oral) at the time of trial treatment initiation Patients using systemic steroids or immunosuppressive agents at the time of trial treatment initiation Patients with comorbid diseases that affect the immune system (autoimmune diseases, immune complex diseases, immunodeficiency disorders, etc.) Cases where the physician judges that trial execution would be difficult Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 28 Day Anticipated trial start date - 2025 Year 11 Month 01 Day Last follow-up date - 2030 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067364

Disclaimer: Curated by HT Syndication.