A randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy of the synbiotic medical food, SBD111, for the clinical dietary management of bone loss in menopausal women
Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Summary: This 12-month study in 286 early postmenopausal women evaluated the efficacy and safety of SBD111, a synbiotic medical food, in reducing bone loss. SBD111 did not significantly reduce bone loss for the full cohort, but did produce evidence of reduced bone loss in women with osteopenia and BMI ≥ 30. Purpose: To determine the efficacy of SBD111, a synbiotic medical food comprising probiotics and prebiotics, in reducing bone loss in women post-menopause, including prespecified subpopulations of women with osteopenia or elevated BMI. Methods: colony forming units) or placebo (maltodextrin) capsules twice daily for 12-months. The primary endpoint was change in areal BMD at the lumbar spine (LS). Secondary endpoints included change in areal BMD at the femoral neck (FN) and total hip (TH), trabecular volumetric BMD at the LS, markers of bone turnover and inflammation, and safety. Changes in gut microbiome composition were exploratory. The hypotheses being tested were formulated before data collection. Results: 286 Women [age 55 ± 3 years (mean ± standard deviation)] were enrolled, with 221 (77%) completing the study. For the primary outcome, SBD111 administration was not associated with significantly less bone loss in the LS after 12-months [0.15% (-0.52%, 0.82%), mean effect size (95% CI) by linear mixed effects regression]. However, SBD111 was associated with reduced BMD loss in the TH for women with BMI ≥ 30 [0.97% (0.015%, 1.925%)] and modestly reduced BMD loss in the FN for women with osteopenia [0.89% (-0.277%, 2.051%)]. Conclusions: These findings indicate SBD111 did not significantly reduce BMD loss for the full cohort. However, the trial produced evidence that SBD111 reduced bone loss in women with osteopenia and BMI ≥ 30.
Source: Osteoporosis International
Authors: Eric M. Schott, Mark R. Charbonneau, Douglas P. Kiel, Susan Bukata, Michael J. Zuscik, Clifford Rosen, Alicia Ballok, Gerardo V. Toledo, Elizabeth Steels, Harry Huntress, Amanda Rao, Phillippa Ebelt, Thomas G. Travison, Maria J. Soto-Giron, Ian Wolff, D. Davidson Easson, Klaus Engelke, Luis Vitetta
Institutions: Solarea Bio (United States), Beth Israel Deaconess Medical Center, Harvard University, Hebrew SeniorLife, University of California San Diego, University of Colorado Anschutz, MaineHealth, The University of Queensland, Queensland University of Technology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitätsklinikum Erlangen, The University of Sydney
Language: English
Subfield: Orthopedics and Sports Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,090
OpenAlex ID: W4413139133