Clinical trial · Interventional
Orall Administered Probiotics to Improve the Quality of the Vaginal Flora of Women With Breast Cancer and Chemotherapy.
The Ability of an Orally Administered Preparation of Four Lactobacillus Species to Improve the Quality of the Vaginal Flora of Women With Breast Cancer and Chemotherapy. A Prospective Randomized Placebo-controlled, Double-blind Trial
NCT01723592CI-TRIAL-00027998completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of this study is the improvement of the vaginal flora by at least two grades of the Nugent scale after application of oral probiotics.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral lactose placebo | Dietary Supplement | — | UNRESOLVED |
| Probiotics | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 30 participants in this group receive a oral lactose placebo
- interventionNames
- Dietary Supplement: Oral lactose placebo
- type
- ACTIVE_COMPARATOR
- label
- Probiotics
- description
- 30 participants in this group receiving oral probiotic capsules for 7 days twice daily containing four lyophilised Lactobacillus strains belonging to the species: L.rhamnosus/ LbV96 (DSM 22560) L.jensenii /LbV 116 (DSM 22567) L.crispatus/ Lbv88 (DSM 22566) L.gasseri /LbV 150N (DSM 22583)
- interventionNames
- Dietary Supplement: Probiotics
Primary outcomes (1)
- measure
- change in Nugent score between baseline and end of treatment (improvement or no improvement)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: Only women with breast cancer and neoadjuvant / adjuvant chemotherapy, at least 4 weeks postoperative, without vaginal bleeding without abnormal vaginal discharge, Only women with Nugent scores between 4 and 6 Exclusion Criteria: Patients with diarrhoea, constipation, vaginal or urinary tract infection requiring antibacterial treatment and women receiving antibiotic therapy in the previous 4 weeks.
References
Publications (0)
Data not yet available
No reference posted for this study.