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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-31

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer Osteoporosis, Osteopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dietary supplement 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

Group Type ACTIVE_COMPARATOR

Vivomixx

Intervention Type DRUG

The intervention consists of 2 sachets a day containing the probiotic Vivomixx, for 6 months

Placebo

The placebo sachets contain the inactive ingredients maltose and silicon dioxides

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The intervention consists of 2 sachets a day of placebo, for 6 months

Interventions

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Vivomixx

The intervention consists of 2 sachets a day containing the probiotic Vivomixx, for 6 months

Intervention Type DRUG

Placebo

The intervention consists of 2 sachets a day of placebo, for 6 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age≥ 35 years
2. Breast cancer stages 1-3 (non metastatic)
3. Under treatment with aromatase inhibitors
4. In menopausal status for ≤10y
5. Estrogen receptor positive tumor
6. CTX ≥300 pg/ml

Exclusion Criteria

1. Distant metastases
2. Additional active primary malignancy
3. Metabolic bone disease (primary hyperparathyroidism, hyperthyroidism, paget, osteomalacia etc)
4. Glucocorticoid treatment (chronic or high dose \>7.5 mg in the last three months)
5. Bisphosphonate treatment for more than 3 months in the last 2 years
6. Bone densitometry (DXA) T-Score \<-2 unless not a candidate for antiresorptive therapy (unwilling/unable to take treatment)
7. Lactose intolerant subjects

Minimum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No