Tokyo, May 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061425) titled 'Single-Group Intervention Study on the Early Introduction of Multiple Nuts Using a Mixed Powder Formula for Infants' on May 10.

Study Type: Interventional

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

Primary Sponsor: Institute - National Center for Child Health and Development

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

Objective: Narrative objectives1 - The purpose of this study is to investigate the safety and feasibility of long term consumption of a mixed peanut and nut powder developed to be easily and safely consumed by infants and young children without food allergies in their homes. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Participants will visit the National Center for Child Health and Development, where consent will be obtained from the subjects' parent or legal guardian before the case is registered. After registration, the subject will be given the mixed powder mixed into baby food, and a physician will assess for the occurrence of immediate type allergic reactions. For those confirmed to be able to consume the mixture without adverse events, the mixed powder will be provided for continued consumption at home for two months. If safety and tolerability are confirmed every two months, the dose will be increased as in the initial phase.

Eligibility: Age-lower limit - 5 months-old

Gender - Male and Female Key inclusion criteria - Children aged 5 months to 1 year and 6 months at the start of the study, along with their guardians. Participants for whom consent has been obtained from a legal guardian acting as a proxy. Key exclusion criteria - 1. Children with active eczema at the time of enrollment 2. Children with a history of or concurrent food allergies 3. Children who, due to swallowing difficulties or other reasons, are unable to consume weaning foods of a consistency appropriate for their age 4. Children whose caregivers are unable to communicate effectively in Japanese 5. Children suffering from a medical condition that would interfere with this study 6. Children deemed unsuitable by a physician Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 01 Day Anticipated trial start date - 2026 Year 06 Month 01 Day Last follow-up date - 2028 Year 02 Month 28 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070286

Disclaimer: Curated by HT Syndication.