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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Probiotics
Oral lactose placebo
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring chemotherapy, vaginal flora

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of Vienna - Department of Obstetrics and Gynecology

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Probiotics

Arm Description

30 participants in this group receive a oral lactose placebo

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)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

Full Information

First Posted
November 6, 2012
Last Updated
June 4, 2017
Sponsor
Medical University of Vienna
Collaborators
University of Natural Resources and Life Sciences, Vienna, Austria
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1. Study Identification

Unique Protocol Identification Number
NCT01723592
Brief Title
Orall Administered Probiotics to Improve the Quality of the Vaginal Flora of Women With Breast Cancer and Chemotherapy.
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
Collaborators
University of Natural Resources and Life Sciences, Vienna, Austria

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
chemotherapy, vaginal flora

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
30 participants in this group receive a oral lactose placebo
Arm Title
Probiotics
Arm Type
Active Comparator
Arm 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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics
Other Intervention Name(s)
L.rhamnosus/ LbV96 (DSM 22560), L.jensenii /LbV 116 (DSM 22567), L.crispatus/ Lbv88 (DSM 22566), L.gasseri /LbV 150N (DSM 22583)
Intervention Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral lactose placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
change in Nugent score between baseline and end of treatment (improvement or no improvement)
Description
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)
Time Frame
day 0, 7 and day 14 of oral probiotic application
Secondary Outcome Measure Information:
Title
Isolation of specific Lactobacilli from vaginal microbiologic cultures after oral administration of probiotic
Description
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.
Time Frame
day 0, 7 and day 14 after oral probiotic application

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert Kiss, MD
Organizational Affiliation
Medical University of Vienna, Dept. of Obstetrics and Gynecology
Official's Role
Study Director
Facility Information:
Facility Name
Medical University of Vienna - Department of Obstetrics and Gynecology
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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