Randomized clinical trial to test the safety and tolerability of SBD111, an optimized synbiotic medical food combination designed for the dietary management of the metabolic processes underlying osteopenia and osteoporosis.

To determine the effect of a twice daily administration of SBD111 on safety and tolerability in healthy adults in a randomized, placebo-controlled trial over 28-days. Participants were randomized to either SBD111 (n=15) or placebo (n=17). The outcomes were the number, frequency, and severity of Gastrointestinal (GI) symptoms and the number and severity of adverse events (AEs) over 28-days. Stool samples were collected and analyzed at baseline, after 28- and 56-days. Groups were compared (P< 0.05) using an intention-to-treat approach. The two groups were similar at baseline. After 28-days, the presence of GI symptoms tended to be higher with SBD111 use vs placebo (P=0.08) but the total number, frequency/severity of GI symptoms did not significantly differ. The number of AEs possibly related to the study were higher with SBD111 use vs placebo (P=0.05), there were no significant differences in the mean number/severity of AEs. The majority of reported AEs were mild, some were moderate, but none were severe. There were no significant differences in alpha diversity indices between the two groups at baseline or follow-up. SBD111 strains were identified in stool, enriched metabolic pathways for menaquinone (vitamin K2) production at 28-days, and were not detected at 56-days. The relatively low frequency and mild severity of GI symptoms and AEs suggests that SBD111 at the level tested is safe for human consumption.