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

Medical University of Vienna

Status: Completed

Conditions: Breast Cancer

Treatments: Dietary Supplement: Probiotics; Dietary Supplement: Oral lactose placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01723592

MUW EK 1417/2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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27 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

30 participants in this group receive a oral lactose placebo

Treatment:

Dietary Supplement: Oral lactose placebo

Probiotics

Active Comparator group

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)

Treatment:

Dietary Supplement: Probiotics