A synbiotic medical food improves gut barrier function, reduces immune responses, and inhibits osteoclast activity in models of postmenopausal bone loss aligned with clinical outcomes.

UNLABELLED: Over half of women above age 50 are affected by osteopenia or osteoporosis, boneloss conditions influenced by estrogen decline, inflammation, and the intestinal microbiota. Probiotic-based interventions have shown promise in preclinical osteoporosis models. In a recent randomized, double-blind, placebo-controlled clinical trial of postmenopausal women, dietary intervention with SBD111, a synbiotic medical food combining plant-derived probiotics and prebiotic fibers, reduced bone loss in women with osteopenia, elevated body mass index (BMI), and/or elevated body fat. To investigate potential mechanisms underlying these outcomes, we examined intestinal epithelial, immune, and osteoclast responses to SBD111 in vitro. SBD111 administration improved intestinal barrier integrity, reduced immune cell cytokine secretion, and inhibited osteoclast activity. These effects align with clinically observed reductions in severe gastrointestinal symptoms and bone resorption markers. Together, these findings suggest that SBD111 modulates the gut-bone axis via barrier, immune, and antiresorptive pathways, supporting its role in maintaining skeletal health in postmenopausal women.

IRB STATEMENTS: The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Institutional Review Board of MaineHealth under protocol 1689738-1 (approved 12/29/2020) and 958914 (approved 05/31/2005). Human peripheral blood mononuclear cells (PBMCs) were purchased from Charles River Laboratories and collected under their IRB-approved protocol with informed consent for commercial research use.Informed Consent StatementsInformed consent was obtained from all participants involved in the study.

HIGHLIGHTS: SBD111 synbiotic medical food improves intestinal barrier functionSBD111 reduces cytokine release from inflamed immune cellsThis synbiotic medical food inhibits osteoclast activity in vitroIn vitro SBD111 effects align with clinical reductions in bone loss and CTX-1.