A Phase 1b/2 randomized double-blind placebo-controlled multi-center study of STMC-103H in neonates and infants at high-risk for developing allergic disease
Brief description of study
The purpose of this research study is to evaluate the safety and effectiveness of STMC-103H. STMC- 103H is an investigational product and is a mixture of bacteria, which are found in the gut of healthy newborns from the very first days of life. This study is testing whether administration of STMC- 103H to babies may help prevent and treat allergic diseases, including atopic dermatitis (eczema), food allergy, asthma, and allergic rhinitis (hay fever). This study will last about 2 years. The participant will receive either STMC-103H or placebo (an inactive substance) to mix with their breastmilk, formula, or milk product daily for approximately one (1) year (336 days). After the last dose of STMC-103H or placebo is taken, the participant will remain in the study for an additional one (1) year (approximate, 336 days) to collect additional samples and to monitor for safety purposes.
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