Clinical Trial: Randomized trial of weaning food for prevention of peanut and nut allergy (Japan)

Tokyo, Feb. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060581) titled 'Randomized trial of weaning food for prevention of peanut and nut allergy' on Feb. 4.

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 - To clarify whether early consumption of peanut, walnut, and cashew with weaning food can prevent development of these allergies. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Consume weaning food with peanuts, walnuts, and cashews at least twice a week from 1 year to 1 year and 6 months Interventions/Control_2 - Consume placebo weaning food at least twice a week from 1 year to 1 year and 6 months

Eligibility: Age-lower limit - 6 months-old

Gender - Male and Female Key inclusion criteria - Infants under 1 year of age at the time of study enrollment who have sensitization to one or more food allergens by blood test between 6 to 11 months of age. Key exclusion criteria - Severe atopic dermatitis Infants with a history of immediate symptoms to peanuts, walnuts, or cashews Infants with sensitization to peanuts, walnuts, cashews, Ara h 2, Jug r 1, or Ana o 3 by blood test Infants with concomitant immune disorders Infants with a history or complications of cardiac, liver, kidney, or blood disease Infants using systemic steroids regularly Infants using systemic biologics Decision of ineligibility by a physician Target Size - 136

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2024 Year 12 Month 01 Day Date of IRB - 2024 Year 11 Month 08 Day Anticipated trial start date - 2024 Year 12 Month 01 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065121

Disclaimer: Curated by HT Syndication.