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临床试验/NCT03518268
NCT03518268Unknown1 期

The Efficacy of the Probiotic Supplement Vivomixx on Prevention of Bone Loss in Early Menopausal Women With Breast Cancer Treated With an Aromatase Inhibitor

Tel-Aviv Sourasky Medical Center0 个研究点目标入组 40 人开始时间: 2019年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
40
主要终点
Collagen type 1 cross-linked C-telopeptide (CTX)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Placebo

Placebo Comparator

The placebo sachets contain the inactive ingredients maltose and silicon dioxides

干预措施: Placebo (Drug)

Dietary supplement Vivomixx

Active Comparator

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

干预措施: Vivomixx (Drug)

结局指标

主要结局

Collagen type 1 cross-linked C-telopeptide (CTX)

时间窗: 3-6 months

Change in percent in CTX in serum compared to placebo

Serum type 1 procollagen (N-terminal) P1NP

时间窗: 3-6 months

Change in percent in serum in P1NP compared to placebo

次要结局

  • Alkaline phosphatase/ bone specific alkaline phosphatase(3-6 months)
  • Osteocalcin(3-6 months)
  • Sclerostin(3-6 months)
  • Tumor-necrosis factor-alpha(3-6 months)
  • Interleukin-17(3-6 months)
  • Receptor activator of nuclear factor kappa B ligand (RANK-ligand)(3-6 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

michal roll

Deputy Director General for R&D

Tel-Aviv Sourasky Medical Center

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