Enhancing Innate Immunity through Gummies Enriched with a Prebiotic Fiber (β-Glucan) and Micronutrients: IMMUNO SHIELD TRIAL, Proof of Concept, Single Arm, Open Label Trial in Children Aged 3 - 6 Years

Background: Undernourishment occurs when the body is deficient in essential nutrients, which impacts growth and overall bodily functions. It can be caused by an inadequate diet, poor nutrient absorption, economic challenges, and illnesses. The function of the innate immune system is weaker in young children compared to later stages of life, and building strong immunity is crucial for safeguarding them against various diseases. Children with robust immune systems are better equipped to fight infections and recover more quickly from illnesses. Improving the nutritional intake of young children with a daily supplement that contains a prebiotic fiber-β-glucan and iron, along with other micronutrients, can significantly enhance the immunity, nutritional status as well as iron status in children. Objective: This single-arm, open-label study investigates the impact of gummies containing prebiotic fiber-β-glucan and micronutrients on the innate immunity and iron status of children aged 3 to 6 years with haemoglobin concentration between 9 and 11 g/dL and a history of at least two infections in the past three months. Method: Following informed consent from parents or legally acceptable representatives, 44 subjects were enrolled, with 38 completing the study. The intervention involved daily consumption of three gummies over three months. Clinical evaluations were conducted at baseline, one month, and three months. Primary outcomes included innate immunity markers such as Natural Killer (NK) cell activity, including CD3, CD3/CD (16 + 56), Absolute Neutrophil Count, Immunoglobulins IgA and IgE levels, and C-Reactive Protein. Secondary outcomes included type and number of episodes of infection and the adapted KIDSCREEN QOL-27 quality of life questionnaire. Iron status was also assessed through various indicators. Results: The study found significant improvements in innate immunity markers, including increased NK cell activity, increased CD3 (Total Cells) (%) (p value = 0.0213) and CD3/CD (16 + 56) (%) (p value = 0.0013) counts at 3 months from baseline, increased IgA levels (p value = 0.0009), and decreased CRP levels, indicating enhanced innate immunity. Additionally, a significant reduction in episodes of cold, occurrences of runny nose, and composite respiratory illness parameters such as all flu like respiratory symptoms cold, cough, runny nose and fever were observed at month 1 and month 3 when compared against baseline using McNemar test p < 0.0001 for cold episodes, p value = 0.0020 for runny nose, and p