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
Primary result · Change in LS areal BMDResult — go to the resultMean effect size 0.15 % 95% CI - 0.52%, 0.82%Authors' conclusion
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.
Study context
- Population
- Healthy, non-osteoporotic women 1–6 years post-menopause; age 55 ± 3 years (mean ± SD)221 completed
- Participants
- 286 participants
- Comparison
- SBD111 vs placebo
- Primary endpoint
- Change in areal BMD at the lumbar spine (LS)
- Follow-up
- 12 months
Methodological detailsprospective, multicentre, double-blind, placebo-controlled
- Prospective
- Multicentre
- Double-blind
- Placebo-controlled
Primary result
Change in LS areal BMD
Mean effect size
0.15 %
95% CI - 0.52%, 0.82%
As reported in the abstract
Secondary outcomes
| Outcome | Mean effect size (%) (95% CI) |
|---|---|
| Change in TH areal BMD, women with BMI ≥ 30 · 12 monthsReduced BMD loss with SBD111 | 0.97 (0.015%–1.925%) |
| Change in FN areal BMD, women with osteopenia · 12 monthsModestly reduced BMD loss with SBD111 | 0.89 (- 0.277%, 2.051%) |
Original publication
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. Osteoporos Int. Published 15 August 2025. doi:10.
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