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Completed

NCT Number: NCT01723592

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna - Department of Obstetrics and Gynecology

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotics

Dietary Supplement

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)

Oral lactose placebo

Dietary Supplement

Placebo

Primary outcomes

  1. change in Nugent score between baseline and end of treatment (improvement or no improvement)

    Time frame: 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 outcomes

  1. Isolation of specific Lactobacilli from vaginal microbiologic cultures after oral administration of probiotic

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • University of Natural Resources and Life Sciences, Vienna, Austria

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 8, 2012
Registry last updated
Jun 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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