Study to Evaluate the Safety and Effects of Bacillus coagulans SNZ 1969 on Immune Health in Healthy Children Aged 6 to 12 Years Attending School

What this Trial Is About

Researchers are studying the effects of Bacillus coagulans SNZ 1969 on immune health in healthy children aged 6 to 12 years who attend school. The study aims to compare the probiotic to a placebo in reducing symptoms of upper respiratory tract infections URTI and gastrointestinal tract infections GITI during the 2025-2026 cold and flu season. The main focus is on measuring the incidence, duration, and severity of these infections using specific symptom questionnaires and immune biomarkers. Participants will be randomly assigned to receive either the Bacillus coagulans SNZ 1969 probiotic sachet containing 1 billion CFUg or a placebo sachet daily for 84 days. The sachets are dissolved in water and taken before breakfast. The study includes a screening period, a 14-day run-in with symptom diaries, followed by baseline assessments and randomization. Remote visits occur on days 28 and 56, with the final clinic visit at day 84 involving sample collection and safety evaluations. Throughout the study, children and their caregivers will complete symptom diaries and questionnaires related to respiratory and gastrointestinal symptoms. Clinical assessments include measurements of vital signs, weight, height, and collection of blood, saliva, and stool samples to analyze immune responses and microbiome changes. Compliance with the study product is monitored by counting returned sachets. Safety and adverse events are closely tracked, and the study maintains strict confidentiality and data security. Participants are involved for approximately 84 days from baseline to the end of the study.

Effects of Bacillus Coagulans SNZ 1969 on Immune Health in Healthy School-aged Children