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 In this prospective, multicenter, double-blind, randomized, placebo-controlled clinical food trial (NCT05009875), 286 healthy, non-osteoporotic women between 1-6 years post-menopause were enrolled and consumed SBD111 (4.75×1010 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.

E.M.S., M.R.C., A.B., GVT, M.J.S.G., I.W., and D.D.E. are employees of Solarea Bio. D.K., S.B., M.Z., and C.R. are advisors of Solarea Bio. D.K. received grant funding from Solarea Bio to conduct a human safety and tolerability clinical trial and has received an NIH RO1 (R01AG079952) to conduct a clinical trial of SBD111 in women over 60-years of age. K.E. is a part time employee of Clario. The authors declare no additional conflicts of interest.

NCT05009875

This research was funded by Solarea Bio, Inc

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The study was conducted in accordance with the Declaration of Helsinki, and approved by the National Institute of Integrative Medicine Human Research Ethics Committee (EC00436) in Brisbane, QLD, Australia (Reference Number: 0089E_2021, August 26, 2021).

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