Participant baseline demographics, compliance and adverse events reporting
bloating, nausea, flatulence, abdominal pain, infection, Abdominal pain, headache
ADVERSE EVENTS, INFECTION
A total of 41 healthy young adults were enrolled in this open-label study. The participants were all given the interventional product 14-strain probiotic blend. Two participants withdrew from the study; one contracted an infection that required treatment with antibiotics and ‘no reason’ for withdrawal was given by the other participant.A summary of participants characteristics at baseline is shown in At baseline, 65% of participants reported no experiences of abdominal pain, 73% reported having never or only occasionally experienced bloating and 54% of participants reported never or only occasional discomfort from gas. Abdominal pain was the least prominent of the reported GI discomforts and gas was comparatively more frequently experienced There were no serious adverse events reported. There were a total of 11 adverse events (AE) reported during the 8 week probiotic consumption period. Of those four were likely related to product intake (flatulence, bloating, headache and nausea). The AE were mild and transient as resolved within 2 days.Participants’ compliance with product consumption was modest with an average product intake of 83%. Only 73% of the participants took more than 80% of the given product.The trial started in November 2019 in the UK. It should be noted that during the trial period, the UK experienced variable restrictions and lockdowns due to the COVID-19 pandemic. Compliance and missing data are partly explained by the challenges faced during that period.