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
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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)
day 0, 7 and day 14 of oral probiotic application
No
Herbert Kiss, MD
Study Director
Medical University of Vienna, Dept. of Obstetrics and Gynecology
Austria: Ethikkommission
MUW EK 1417/2012
NCT01723592
October 2012
May 2013
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