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

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ClinicalTrials.gov Identifier: NCT01723592
Recruitment Status : Completed
First Posted : November 8, 2012
Last Update Posted : June 6, 2017
Sponsor:
Collaborator:
University of Natural Resources and Life Sciences, Vienna, Austria
Information provided by (Responsible Party):
Associate Prof. Ljubomir Petricevic MD, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Dietary Supplement: Probiotics Dietary Supplement: Oral lactose placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
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 Start Date : October 2012
Actual Primary Completion Date : August 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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)




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723592


Locations
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Austria
Medical University of Vienna - Department of Obstetrics and Gynecology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
University of Natural Resources and Life Sciences, Vienna, Austria
Investigators
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Study Director: Herbert Kiss, MD Medical University of Vienna, Dept. of Obstetrics and Gynecology

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Responsible Party: Associate Prof. Ljubomir Petricevic MD, Assistant Professor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01723592     History of Changes
Other Study ID Numbers: MUW EK 1417/2012
First Posted: November 8, 2012    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Associate Prof. Ljubomir Petricevic MD, Medical University of Vienna:
chemotherapy
vaginal flora

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases