Breast Cancer Clinical Trial
Official title:
The Efficacy of the Probiotic Supplement Vivomixx on Prevention of Bone Loss in Early Menopausal Women With Breast Cancer Treated With an Aromatase Inhibitor
This study evaluates the efficacy of the probiotic food supplement Vivomixx in the prevention of bone loss occurring in post menopausal women with breast cancer treated with an aromatase inhibitor. Half of the participants will receive Vivomixx while the other half will receive a placebo. The primary endpoint is to assess changes of bone turnover markers during the period of 6 months.
Aromatase inhibitors function to reduce estrogen levels. They are considered first-line
treatment for postmenopausal women with estrogen receptor-positive breast cancer. Estrogen
depletion leads to significant loss of bone mineral density and an increased fracture risk.
One contributing mechanism to "estrogen deficiency associated bone loss" is the increase in
systemic and local gut inflammatory responses upon estrogen deficiency. Probiotics have been
shown to decrease inflammatory cytokine formation in both the systemic circulation and gut.
Vivomixx is a high potency probiotic medical food designated for the dietary management of
inflammatory gut conditions in adults and children and is currently being studied in clinical
trials in a wide variety of inflammatory conditions such as asthma and diabetes. In
preclinical studies Vivomixx has been shown to protect from estrogen deficient bone loss.
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