NCT03518268

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1 breast-cancer

Timeline
Completed

Started Jan 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 8, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

January 17, 2019

Status Verified

January 1, 2019

Enrollment Period

2.2 years

First QC Date

April 25, 2018

Last Update Submit

January 16, 2019

Conditions

Breast CancerOsteoporosis, Osteopenia

Keywords

probioticsaromatase inhibitorsbone masspostmenopausal

Outcome Measures

Primary Outcomes (2)

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

    Change in percent in CTX in serum compared to placebo

    3-6 months

  • Serum type 1 procollagen (N-terminal) P1NP

    Change in percent in serum in P1NP compared to placebo

    3-6 months

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

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

Drug: Vivomixx

Placebo

PLACEBO COMPARATOR

The placebo sachets contain the inactive ingredients maltose and silicon dioxides

Drug: Placebo

Interventions

VivomixxDRUG

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

Dietary supplement Vivomixx
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age35 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast NeoplasmsOsteoporosisBone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Naftali Stern, M.D

    Tel-Aviv Sourasky Medical Center

    STUDY DIRECTOR

Central Study Contacts

Sigal Shaklai, M.D, Ph.D

CONTACT

+972-3-6973732Sigal.shaklai@gmail.com

Vanessa Rouach, M.D

CONTACT

+972-3-6973732vanessar@tlvmc.gov.il

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director General for R&D

Study Record Dates

First Submitted

April 25, 2018

First Posted

May 8, 2018

Study Start

January 1, 2019

Primary Completion

April 1, 2021

Study Completion

June 1, 2021

Last Updated

January 17, 2019

Record last verified: 2019-01