Evaluation of the efficacy of Lactobacillus-containing feminine hygiene products on vaginal microbiome and genitourinary symptoms in pre- and postmenopausal women: A pilot randomized controlled trial

PLOS ONE RESEARCH ARTICLE Evaluation of the efficacy of Lactobacilluscontaining feminine hygiene products on vaginal microbiome and genitourinary symptoms in pre- and postmenopausal women: A pilot randomized controlled trial a1111111111 a1111111111 a1111111111 a1111111111 a1111111111 Remi Yoshikata1,2, Michiko Yamaguchi1☯, Yuri Mase1,2☯, Ayano Tatsuyuki1,2☯, Khin Zay Yar Myint ID2*, Hiroaki Ohta3,4 1 Hamasite Clinic, Minato-ku, Tokyo, Japan, 2 Tokyo Midtown Medical Center, Minato-ku, Tokyo, Japan, 3 Kawasaki Medical School Hospital, Okayama, Japan, 4 Fujita Health University Hospital, Inter National Medical Center, Aichi, Japan ☯ These authors contributed equally to this work. * OPEN ACCESS Citation: Yoshikata R, Yamaguchi M, Mase Y, Tatsuyuki A, Myint KZY, Ohta H (2022) Evaluation of the efficacy of Lactobacillus-containing feminine hygiene products on vaginal microbiome and genitourinary symptoms in pre- and postmenopausal women: A pilot randomized controlled trial. PLoS ONE 17(12): e0270242. https://doi.org/10.1371/journal.pone.0270242 Editor: Walid Kamal Abdelbasset, Prince Sattam Bin Abdulaziz University, College of Applied Medical Sciences, SAUDI ARABIA Received: June 6, 2022 Accepted: September 23, 2022 Published: December 30, 2022 Copyright: © 2022 Yoshikata et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability Statement: All relevant data are within the paper and its Supporting Information files. Funding: The Hamasite Clinic and Tokyo Midtown Medical Center receive administrative support from Advanced Medical Care Inc. Advanced Medical Care Inc. provided financial support for this research. The funder provided support in the form Abstract As estrogen level decreases with aging, the vaginal mucosa gets thinner, and collagen amount decreases. In addition, the population of Lactobacillus in the vagina declines, increasing the risk of atrophic vaginitis, bacterial vaginosis, and genitourinary symptoms in the postmenopausal women. In this study, we evaluated the effects of Lactobacillus-containing feminine hygiene products on vaginal microbiome and genitourinary symptoms in pre- and postmenopausal women. This was a pilot randomized controlled trial in 35 premenopausal and 35 postmenopausal healthy women. For 4 weeks, treatment 1 group (14 premenopausal and 16 postmenopausal women) used the Lactobacillus-containing feminine soap and cream, and treatment 2 group (15 premenopausal and 14 postmenopausal women) used Lactobacillus-containing feminine gel in addition to soap and cream. The remaining 6 premenopausal and 5 postmenopausal women served as controls without using any products. We then compared the changes in the vaginal microbiota, genitourinary symptoms, and other related biomarkers after completion of treatment. Vaginal pH and pathogenic flora were reduced in both treatment groups compared to control group, which was more significant in the treatment 2 group of postmenopausal women. Genitourinary symptoms significantly improved in 60% of premenopausal women in treatment 1 group and 81.3% of postmenopausal women in treatment 2 group, compared to control group (0%, p = 0.043 and p<0.01 respectively). Overactive bladder symptom scores were significantly improved after using the products in eleven out of twelve postmenopausal women suspected of having overactive bladder. The use of Lactobacillus-containing feminine products was associated with improved vaginal ecosystem and urogenital health compared to control group, especially in those women using feminine gel. PLOS ONE | https://doi.org/10.1371/journal.pone.0270242 December 30, 2022 1 / 18 PLOS ONE of salaries for authors [RY, MY, YM, AT, KZYM], but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. Competing interests: The authors have declared that no competing interests exist. Effects of Lactobacillus containing feminine hygiene products on the wellbeing of women Introduction Lactobacillus species, belonging to the group of lactic acid bacteria (LAB), are widely found in fermented food as well as in humans and animals. They produce lactic acids, thus lower pH and inhibit the growth of bacteria. Therefore, Lactobacillus species, through their natural protective actions, maintain the ideal vaginal environment and vaginal health [1]. In female vagina, there are five community types or community state types (CSTs) of bacteria [2]. Among them four are Lactobacillus dominant types with low microbial diversity: Lactobacillus crispatus (CST I), Lactobacillus gasseri (CST II), Lactobacillus iners (CST III) and Lactobacillus jensenii (CST V). The ranking of Lactobacillus was in the order of CST I, II, V, and III. The better the rank was, the lower the risk of sexually transmitted infections [3]. The last community state type is the CST IV or diversity type, which has a greater diversity of bacterial taxa with low proportions of typical Lactobacillus species. CST IV can be further clustered into CST IV-A and CST IV-B, with respect to different compositions of bacterial species [4]. Diversity type is associated with an increased risk for various gynecological problems [5–7]. The prevalence of CSTs varies across different ethnic groups or geographical locations [2]. In addition to this spatial heterogeneity, it possesses temporary heterogeneity as it can change in the same individual across time, in response to the level of circulating estrogen [8]. As blood estrogen declines with age, Lactobacillus population is dramatically reduced. In addition, estrogen decline is associated with the loss of collagen and elastin, thinning of the vaginal epithelium and reduced elasticity [9]. These changes also occur in the urinary tract because it has the same embryonic origin as the genital tract. As a result, there are increased risks of bacterial vaginosis and genitourinary symptoms of menopause (GSM) [10]. GSM results from anatomical, histological and functional changes of the female genitourinary system due to reduced estrogen levels and ageing. GSM includes genital symptoms (dryness, burning, itching, irritation, bleeding), sexual symptoms (dyspareunia and other sexual dysfunctions) and urinary symptoms (dysuria, frequency, urgency, recurrent urinary infections) [11]. Treatments for GSM are usually effective if started as early as possible at the onset of the signs and symptoms. Treatment options include both hormonal and non-hormonal therapies, as well as physical therapies. However, most of the women with GSM remained unrecognized and untreated [12,13]. Moderate to severe genitourinary symptoms might need hormonal therapies such as local estrogen treatment. However, probiotics therapies have emerged in recent days as an alt (...truncated)