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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Dietary Supplement: Oral lactose placebo; Dietary Supplement: Probiotics

• Registration Number: NCT01723592
• Lead Sponsor: Medical University of Vienna

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-06
• Study First Submitted QC: 2012-11-07
• Study First Posted: 2012-11-08
• Primary Completion: 2016-08
• Study Completion: 2016-10
• Status Verified: 2016-11
• Last Update Submitted: 2017-06-04
• Last Update Posted: 2017-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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

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Exclusion Criteria

Patients with diarrhoea, constipation, vaginal or urinary tract infection requiring antibacterial treatment and women receiving antibiotic therapy in the previous 4 weeks.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Oral lactose placebo	30 participants in this group receive a oral lactose placebo
Probiotics	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)

Primary Outcome Measures

Name	Time	Method
change in Nugent score between baseline and end of treatment (improvement or no improvement)	day 0, 7 and day 14 of oral probiotic application	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

Name	Time	Method
Isolation of specific Lactobacilli from vaginal microbiologic cultures after oral administration of probiotic	day 0, 7 and day 14 after oral probiotic application	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.

Trial Locations

Locations (1)

Medical University of Vienna - Department of Obstetrics and Gynecology; 🇦🇹 Vienna, Austria