New evidence on oral L. plantarum P17630 product in women with history of recurrent vulvovaginal candidiasis (RVVC): a randomized double-blind placebo-controlled study

R. Vladareanu, D. Mihu, M. Mitran, C. Mehedintu, A. Boiangiu, M. Manolache, S. Vladareanu

University of Medicine and Pharmacy Carol Davila Bucharest, Elias University Hospital, Bucharest, Romania. michael_digital@yahoo.com

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• Pharmacology

OBJECTIVE: To evaluate activity and tolerability of an oral product containing the specific probiotic strain Lactobacillus plantarum P17630 on vaginal colonization of lactic acid bacteria.

PATIENTS AND METHODS: L. plantarum P17630 (5×109 CFU/capsule) or placebo were formulated in capsules and administrated orally to a total of 93 women with a history of recurrent vulvovaginal candidiasis over a period of 3 treatment cycles (15 days/cycle) separated by 15-day wash-out intervals. Vulvovaginal examinations and vaginal mycological culture, including Nugent score and Lactobacillary grade (LBG), were assessed at baseline, at day 45 and at day 90 (end of the study).

RESULTS: Probiotic intake significantly improved lactobacilli colonization on vaginal epithelial cells. The results demonstrated a significant difference in LBG score when comparing day 0 to day 45 (p=0.000016) and to day 90 (p=0.001415) in women treated with L. plantarum P17630. No evidence of improvement in LBG score was recorded in women who received placebo (p<0.005). The increased lactobacilli adhesion was associated with the improvement of clinical signs such as redness, swelling, and discharge.

CONCLUSIONS: This study demonstrates that the administration of oral probiotic Lactobacillus plantarum P17630 improves vagina colonization of acid lactic bacteria (an increase of vaginal LBG score) and suggests the use of this oral product to successfully prevent episodes of vulvovaginal candidiasis. The clinical study described in this article is registered in the ISRCTN registry with trial registration ID ISRCTN12669692.

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