A Phase 1/2 interventional study of Vivomixx and Placebo in Breast Cancer and Osteoporosis, Osteopenia, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown. Open to female participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2019-01-17.
Sponsored by Tel-Aviv Sourasky Medical Center · Phase 1/2, Interventional, and Prevention
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 40 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Tel-Aviv Sourasky Medical Center is the lead sponsor of 541 studies on the registry; 49 are open to participants now.
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Exclusion criteria
Vivomixx sachets contains a mixture of 450 billion viable lyophilized bacteria from 8 strains: Lactobacillus paracasei DSM 24733, Lactobacillus plantarum DSM 24730, Lactobacillus acidophilus DSM 24735, Lactobacillus delbrueckii subspecies bulgaricus DSM 24734, Bifidobacterium longum DSM 3 24736, Bifidobacterium infantis DSM 24737, Bifidobacterium breve DSM 24732, and Streptococcus thermophilus DSM 24731
Drug: Vivomixx
The placebo sachets contain the inactive ingredients maltose and silicon dioxides
Drug: Placebo
The intervention consists of 2 sachets a day containing the probiotic Vivomixx, for 6 months
The intervention consists of 2 sachets a day of placebo, for 6 months
Collagen type 1 cross-linked C-telopeptide (CTX)
Change in percent in CTX in serum compared to placebo
Time frame: 3-6 months
Serum type 1 procollagen (N-terminal) P1NP
Change in percent in serum in P1NP compared to placebo
Time frame: 3-6 months
Alkaline phosphatase/ bone specific alkaline phosphatase
Change in percent in alkaline phosphatase/ bone specific alkaline phosphatase in serum compared to placebo
Time frame: 3-6 months
Osteocalcin
Change in percent in osteocalcin in serum compared to placebo
Time frame: 3-6 months
Sclerostin
Change in percent in sclerostin in serum compared to placebo
Time frame: 3-6 months
Tumor-necrosis factor-alpha
Change in percent in tumor-necrosis factor-alpha in serum compared to placebo
Time frame: 3-6 months
Interleukin-17
Change in percent in interleukin-17 in serum compared to placebo
Time frame: 3-6 months
Receptor activator of nuclear factor kappa B ligand (RANK-ligand)
Change in percent in RANK-ligand in serum compared to placebo
Time frame: 3-6 months
No study locations are listed for this record.
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Tel-Aviv Sourasky Medical Center