Effects of New Infant Formula on Growth, Gut Health, Immunity, and Sleep in Healthy Children Aged 12 to 18 Months

What this Trial Is About

Researchers are evaluating the effects of a new infant formula on growth, gut health, immune function, and sleep status in healthy infants aged 12 to 18 months. This randomized, controlled study includes three parallel groups to compare two investigational formulas with a control group using commercial infant formula or dairy products. The study aims to understand how these formulas influence various health and development outcomes during early childhood. Participants will receive one of two investigational powdered infant formulas designed to provide suitable amounts of protein, carbohydrates, fats, vitamins, and minerals, or they will be assigned to a control group continuing with commercial formula or dairy products. The study lasts 90 days, during which infants receive their assigned feeding regimen. This design allows researchers to compare the nutritional and health impacts of the novel formulas against standard feeding practices. Throughout the study, infants will have regular visits and undergo assessments including measurements of height, weight, and comprehensive nutritional development. Researchers will also measure immune markers like salivary and fecal secretory IgA, lysozyme, and other gut health indicators such as microbiome composition and stool consistency. Guardians must consent and comply with study procedures, including laboratory tests. The total participation period is about three months, with the main outcomes evaluated from baseline to day 90.

Growth and Health Efficacy of Novel Infant Formula : A Randomized Trial