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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Dietary supplement: Oral lactose placebo; Dietary supplement: Probiotics

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna - Department of Obstetrics and Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 30 participants in this group receive a oral lactose placebo	Dietary supplement: Oral lactose placebo; Placebo
Active Comparator: Probiotics; 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; 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); Other Names: L.rhamnosus/ LbV96 (DSM 22560); L.jensenii /LbV 116 (DSM 22567); L.crispatus/ Lbv88 (DSM 22566); L.gasseri /LbV 150N (DSM 22583)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: University of Natural Resources and Life Sciences, Vienna, Austria
• Investigators: Study Director: Herbert Kiss, MD, Medical University of Vienna, Dept. of Obstetrics and Gynecology

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: November 6, 2012
• First Submitted That Met QC Criteria: November 7, 2012
• First Posted (Estimate): November 8, 2012

Study Record Updates

• Last Update Posted (Actual): June 6, 2017
• Last Update Submitted That Met QC Criteria: June 4, 2017
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: chemotherapy; vaginal flora
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: MUW EK 1417/2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No