Clinical trial · Interventional
Vivomixx for Prevention of Bone Loss in Women With Breast Cancer Treated With an Aromatase Inhibitor
The Efficacy of the Probiotic Supplement Vivomixx on Prevention of Bone Loss in Early Menopausal Women With Breast Cancer Treated With an Aromatase Inhibitor
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Osteoporosis, Osteopenia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Vivomixx | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Dietary supplement Vivomixx
- description
- 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
- interventionNames
- Drug: Vivomixx
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- The placebo sachets contain the inactive ingredients maltose and silicon dioxides
- interventionNames
- Drug: Placebo
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available