Tokyo, May 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061465) titled 'A study of sublingual immunotherapy using small amounts of nut powder for children with nut allergy' on May 7.

Study Type: Interventional

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

Primary Sponsor: Institute - University of Toyama

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

Objective: Narrative objectives1 - To evaluate the safety and feasibility of sublingual immunotherapy using micro-dose nut powder measured with the hollow of an EpiPen trainer cap in children with nut allergy, and to explore changes in nut tolerance over 24 months of intervention. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Sublingual immunotherapy using nut powder purchased, ground, and packaged by the investigators. The initial dose is 0.01 g administered in the hospital. The powder is measured using the hollow of an EpiPen trainer cap as a mold, placed under the tongue for 2 minutes, and then swallowed. After safety confirmation, participants continue once-daily administration at home. Dose escalation is considered at approximately 2-month outpatient visits according to the following steps: 0.01 g, 0.02 g, 0.05 g, 0.10 g, 0.15 g, and 0.20 g. For doses of 0.02 g or higher, powder measured multiple times is combined into a single dose and administered at once. The intervention period is up to 24 months.

Eligibility: Age-lower limit - 5 years-old

Gender - Male and Female Key inclusion criteria - 1) Children aged 5 years to under 13 years 2) Suspected immediate-type allergy to nuts and positive serum specific IgE (ImmunoCAP, >=0.35 UA/mL) 3) Written informed consent from parents/guardians and assent from the child when applicable 4) Judged medically appropriate for participation by the treating physician Key exclusion criteria - 1) Poorly controlled asthma (visit for asthma or steroid use within the past 3 months) 2) Other severe chronic diseases such as heart disease, immunodeficiency, or collagen disease 3) Severe developmental delay or behavioral problems making continuation difficult 4) Participation in another clinical study Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 28 Day Anticipated trial start date - 2026 Year 05 Month 07 Day Last follow-up date - 2029 Year 05 Month 06 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070339

Disclaimer: Curated by HT Syndication.