Vivomixx for Prevention of Bone Loss in Women With Breast Cancer Treated With an Aromatase Inhibitor

Phase 1

• Conditions: Breast Cancer; Osteoporosis, Osteopenia
• Interventions: Drug: Vivomixx; Drug: Placebo

• Registration Number: NCT03518268
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-04-25
• Study First Submitted QC: 2018-04-25
• Study First Posted: 2018-05-08
• Status Verified: 2019-01
• Study Start: 2019-01
• Last Update Submitted: 2019-01-16
• Last Update Posted: 2019-01-17
• Primary Completion: 2021-04
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary supplement Vivomixx	Vivomixx	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
Placebo	Placebo	The placebo sachets contain the inactive ingredients maltose and silicon dioxides

Primary Outcome Measures

Name	Time	Method
Collagen type 1 cross-linked C-telopeptide (CTX)	3-6 months	Change in percent in CTX in serum compared to placebo
Serum type 1 procollagen (N-terminal) P1NP	3-6 months	Change in percent in serum in P1NP compared to placebo

Secondary Outcome Measures

Name	Time	Method
Alkaline phosphatase/ bone specific alkaline phosphatase	3-6 months	Change in percent in alkaline phosphatase/ bone specific alkaline phosphatase in serum compared to placebo
Osteocalcin	3-6 months	Change in percent in osteocalcin in serum compared to placebo
Sclerostin	3-6 months	Change in percent in sclerostin in serum compared to placebo
Tumor-necrosis factor-alpha	3-6 months	Change in percent in tumor-necrosis factor-alpha in serum compared to placebo
Interleukin-17	3-6 months	Change in percent in interleukin-17 in serum compared to placebo
Receptor activator of nuclear factor kappa B ligand (RANK-ligand)	3-6 months	Change in percent in RANK-ligand in serum compared to placebo