A clinical study to evaluate the efficacy of the medical food, SBD111, versus placebo for the clinical dietary management of postmenopausal bone loss and menopause symptoms in otherwise healthy menopausal women: a randomized, double blind placebo-controlled trial.

Abstract

Background Adverse shifts in the diversity and abundance of the intestinal microbiome contribute to the progression of musculoskeletal diseases. Hormonal changes that occur during menopause with reduction in estrogen levels, affect bone density, vasomotor, and other physical, psychosocial, and sexual related symptoms. Reductions in endogenous estrogen production have been linked to an increase in cytokines in the skeleton that potentiate bone resorption. Prompting the intestinal microbiome with a dietary intervention that can support an anti-inflammatory environment presents a plausible approach to maintenance of skeletal homeostasis in menopausal women. Methods Three-hundred healthy women within 6 years of menopause will be targeted for enrollment in a prospective, multicentre double-blind 1:1 randomised, placebo-controlled medical food study. Participants will receive an oral medical food or placebo as capsules, two times a day for 12 months. The medical food is a constructed Defined Microbial Assemblage™ (DMA™) product (designated SBD111) composed of four strains of microorganisms isolated from various foods, namely Lactobacillus brevis, Lactobacillus plantarum, Leuconostoc mesenteroides, and Pichia kudriavzevii. The primary endpoint is percent change in bone mineral density (BMD) as measured by dual energy X-ray absorptiometry (DXA) at the lumbar spine (L1-L4) from baseline to 12-months. Secondary endpoint changes include percent change in BMD as measured by DXA at the lumbar spine (L1-L4) from baseline to 6-months), the percent change in trabecular volumetric BMD (vBMD) measured by quantitative computed tomography (qCT) at the lumbar spine (L1 & L2) from baseline to 12-months, and change in bone turnover markers and C-reactive protein (CRP) at 6- and 12-months. Tertiary endpoints include change in BMD from baseline to 6- and 12-months at the femoral neck and hip, menopausal symptoms, body composition, inflammatory markers, gut microbiome composition and function, and safety and tolerability. Discussion The administration of a synbiotic medical food formulation for the dietary management of bone mineral density in healthy postmenopausal women, if successful, represents a large unmet need to develop effective strategies to maintain bone mass after menopause in women.