Study design
bloating, bowel movements, flatulence, abdominal pain
At the baseline visit (Day 0), height and weight were measured, and BMI was calculated. Participants were given a study diary and instructed on how to complete it daily. The study diary recorded information about the number of bowel movements per day, stool consistency, and experiences of abdominal pain, bloating, and flatulence.Additional samples collected at baseline included hydrogen and methane breath testing, which was performed after a fasting period of 12 hours, during which only water was permitted. A baseline stool sample was collected for fecal microbiome analysis. At the end of the study, hydrogen and methane breath testing were performed in the fasted state, and an additional stool sample was collected for fecal microbiome analysis. All baseline samples were compared to those collected at the end of study visit (Day 56 [ ± 2 days]). A schema of the overall study design is detailed in Study design schematic.