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Eur J Clin Microbiol Infect Dis. 2016 Oct;35(10):1701-8. doi: 10.1007/s10096-016-2715-8. Epub 2016 Jul 9.

Is it possible to prevent recurrent vulvovaginitis? The role of Lactobacillus plantarum I1001 (CECT7504).

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Instituto Palacios de Salud y Medicina de la Mujer, Antonio Acuña 9CP, 28009, Madrid, Spain.
Autonomous University of Barcelona, AB-Biotics S.A. Eureka building, 08193, Bellaterra, Barcelona, Spain.
Instituto de Medicina EGR, Camino de la Zarzuela, 19, 28023, Aravaca, Madrid, Spain.
Gynea Laboratorios by Kern Pharma, Pol. Ind. Colom II, C/Venus, 72, 08228, Terrasa, Barcelona, Spain.


The purpose of this study was to prospectively evaluate the impact of the use of L. plantarum I1001 applied vaginally on Vulvovaginal Candidiasis (VVC) time-until-recurrence after treatment with single-dose vaginal clotrimazole. This was a clinical open-label, prospective study of two non-randomized parallel cohorts with symptomatic acute VVC: (1) 33 sexually active women 18-50 years old, prescribed a standard single-dose 500 mg vaginal tablet of clotrimazole followed by vaginal tablets with L. plantarum I1001 as adjuvant therapy, and (2) 22 women of similar characteristics but prescribed single-dose clotrimazole only. Use of the probiotic and factors that might influence recurrence risk (age, recurrent VVC within previous year, antibiotic prior to study enrolment, diaphragm or IUD contraception, among others) were included in a multivariate Cox regression model to adjust for potential between-cohort differences. Probiotic use was associated with a three-fold reduction in the adjusted risk of recurrence (HR [95 %CI]: 0.30 [0.10-0.91]; P = 0.033). Adjusted free-survival recurrence was 72.83 % and 34.88 % for the probiotic and control groups, respectively. A higher cumulative recurrence was also observed in cases with use of antibiotics prior to enrolment (HR [95 %CI]: 10.46 [2.18-50.12]; P = 0.003). Similar findings were found at six months after azole treatment in women with RVVC. Overall, good compliance with the probiotic was reported for 91.3 % of women. The study suggests that follow-up therapy with vaginal tablets with L. plantarum I1001 could increase the effectiveness of single-dose 500 mg clotrimazole at preventing recurrence of VVC, an effect that was also observed in women with recurrent vulvovaginal candidiasis (RVVC) after six months of azole treatment.

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Conflict of interest statement

Compliance with ethical standards Funding Gynea by Kern Pharma funded the study. Conflict of interest J. Espadaler is a full-time employee of AB-Biotics S.A; C. Prieto is a full-time employee of Gynea by Kern Pharma. Ethical approval All the study materials were reviewed and approved by the Ethical Committee of the Hospital Universitario de la Princesa (Madrid, Spain). Informed consent Informed written consent was obtained from all participants prior to enrolment.

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