Orall Administered Probiotics to Improve the Quality of the Vaginal Flora of Women With Breast Cancer and Chemotherapy.

Study Overview
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Brief Summary
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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.

Detailed Description
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The aim of this study is the improvement of the vaginal flora by at least two grades of the Nugent scale. Improvement of Nugent scores should be considered the primary end point of the study. The outcome of the study would be considered positive if significantly more women in the verum cohort achieve such improvement than in the placebo cohort.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Dietary Supplement: Probiotics
* Dietary Supplement: Oral lactose placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>30 participants in this group receive a oral lactose placebo | Dietary Supplement: Oral lactose placebo<br>* Placebo<br>|
| Active Comparator: Probiotics<br>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) | Dietary Supplement: Probiotics<br>* Probiotics oral probiotic capsules for 7 days twice daily containing four lyophilised Lactobacillus strains,L.rhamnosus/ LbV96 (DSM 22560),L.jensenii /LbV 116 (DSM 22567),L.crispatus/ Lbv88 (DSM 22566),L.gasseri /LbV 150N (DSM 22583)<br>* Other names: L.gasseri /LbV 150N (DSM 22583);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Nugent score between baseline and end of treatment (improvement or no improvement) | Using Nugent scoring system, from each participant first swab from the vagina will be taken before start of oral probiotic use.(baseline information) Second swab will be taken on the day following the last administration.(information about change in Nugent) | day 0, 7 and day 14 of oral probiotic application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isolation of specific Lactobacilli from vaginal microbiologic cultures after oral administration of probiotic | From each participant, a vaginal swab for microbiologic cultures will be taken on the first day and that following the last administration for Isolation of oral applied probiotic strains as well as non-lactobacilli-flora. | day 0, 7 and day 14 after oral probiotic application | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy, vaginal flora