Assessment of Live Lactobacilli Recovery from Probiotic Products for Vaginal Application

The interest in the use of probiotics to treat and prevent vaginal infections is known. The new regulation of medical devices by the European Medical Agency (EMA) introduced big changes in Europe regarding probiotic products for vaginal application, as they are no longer considered as medical device...

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Main Authors: Diana Neves Sousa, Carlos Gaspar, Joana Rolo, Gilbert G. G. Donders, José Martinez-de-Oliveira, Rita Palmeira-de-Oliveira, Ana Palmeira-de-Oliveira
Format: Article
Language:English
Published: MDPI AG 2023-10-01
Series:Applied Microbiology
Subjects:
Online Access:https://www.mdpi.com/2673-8007/3/4/82
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author Diana Neves Sousa
Carlos Gaspar
Joana Rolo
Gilbert G. G. Donders
José Martinez-de-Oliveira
Rita Palmeira-de-Oliveira
Ana Palmeira-de-Oliveira
author_facet Diana Neves Sousa
Carlos Gaspar
Joana Rolo
Gilbert G. G. Donders
José Martinez-de-Oliveira
Rita Palmeira-de-Oliveira
Ana Palmeira-de-Oliveira
author_sort Diana Neves Sousa
collection DOAJ
description The interest in the use of probiotics to treat and prevent vaginal infections is known. The new regulation of medical devices by the European Medical Agency (EMA) introduced big changes in Europe regarding probiotic products for vaginal application, as they are no longer considered as medical devices. As the future classification will be as drugs, it will stress the need to define robust and reliable pre-clinical in vitro testing in order to assess the quality, safety and efficacy of probiotics for human use. Before discussing the efficacy in human pathology, it is mandatory to evaluate the survival and multiplication potential of probiotic strains when brought into contact with vaginal fluid. In this work, our objective was to assess the recovery and stability profile of lactobacilli from six vaginal probiotic formulations brought in contact with specific culture media or vaginal fluid simulants (VFS). Overall, the recovery of viable lactobacilli cells from a modified vaginal fluid simulant (MVFS) solution was comparable to the recovery pattern obtained in standard culture medium. Therefore, we conclude that the MVFS seems to better simulate the conditions of the human vaginal fluid, in contrast with other simulants, and may be used to predict the viability of probiotics over time in the normal vaginal milieu. We discovered that each probiotic product has a unique profile that requires stand-alone studies in conditions that mimic the in vivo status in order to assess their preclinical effectiveness and promote their differential use by the medical community.
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spelling doaj.art-34f7745f3c424f5eb08a7c894ccae4e02023-12-29T15:46:05ZengMDPI AGApplied Microbiology2673-80072023-10-01341195120310.3390/applmicrobiol3040082Assessment of Live Lactobacilli Recovery from Probiotic Products for Vaginal ApplicationDiana Neves Sousa0Carlos Gaspar1Joana Rolo2Gilbert G. G. Donders3José Martinez-de-Oliveira4Rita Palmeira-de-Oliveira5Ana Palmeira-de-Oliveira6CICS-UBI—Health Sciences Research Center, University of Beira Interior, 6200-506 Covilhã, PortugalCICS-UBI—Health Sciences Research Center, University of Beira Interior, 6200-506 Covilhã, PortugalCICS-UBI—Health Sciences Research Center, University of Beira Interior, 6200-506 Covilhã, PortugalFemicare Clinical Research for Women, 3300 Tienen, BelgiumCICS-UBI—Health Sciences Research Center, University of Beira Interior, 6200-506 Covilhã, PortugalCICS-UBI—Health Sciences Research Center, University of Beira Interior, 6200-506 Covilhã, PortugalCICS-UBI—Health Sciences Research Center, University of Beira Interior, 6200-506 Covilhã, PortugalThe interest in the use of probiotics to treat and prevent vaginal infections is known. The new regulation of medical devices by the European Medical Agency (EMA) introduced big changes in Europe regarding probiotic products for vaginal application, as they are no longer considered as medical devices. As the future classification will be as drugs, it will stress the need to define robust and reliable pre-clinical in vitro testing in order to assess the quality, safety and efficacy of probiotics for human use. Before discussing the efficacy in human pathology, it is mandatory to evaluate the survival and multiplication potential of probiotic strains when brought into contact with vaginal fluid. In this work, our objective was to assess the recovery and stability profile of lactobacilli from six vaginal probiotic formulations brought in contact with specific culture media or vaginal fluid simulants (VFS). Overall, the recovery of viable lactobacilli cells from a modified vaginal fluid simulant (MVFS) solution was comparable to the recovery pattern obtained in standard culture medium. Therefore, we conclude that the MVFS seems to better simulate the conditions of the human vaginal fluid, in contrast with other simulants, and may be used to predict the viability of probiotics over time in the normal vaginal milieu. We discovered that each probiotic product has a unique profile that requires stand-alone studies in conditions that mimic the in vivo status in order to assess their preclinical effectiveness and promote their differential use by the medical community.https://www.mdpi.com/2673-8007/3/4/82lactobacilliprobioticvaginal fluid simulantmicrobiomerecovery
spellingShingle Diana Neves Sousa
Carlos Gaspar
Joana Rolo
Gilbert G. G. Donders
José Martinez-de-Oliveira
Rita Palmeira-de-Oliveira
Ana Palmeira-de-Oliveira
Assessment of Live Lactobacilli Recovery from Probiotic Products for Vaginal Application
Applied Microbiology
lactobacilli
probiotic
vaginal fluid simulant
microbiome
recovery
title Assessment of Live Lactobacilli Recovery from Probiotic Products for Vaginal Application
title_full Assessment of Live Lactobacilli Recovery from Probiotic Products for Vaginal Application
title_fullStr Assessment of Live Lactobacilli Recovery from Probiotic Products for Vaginal Application
title_full_unstemmed Assessment of Live Lactobacilli Recovery from Probiotic Products for Vaginal Application
title_short Assessment of Live Lactobacilli Recovery from Probiotic Products for Vaginal Application
title_sort assessment of live lactobacilli recovery from probiotic products for vaginal application
topic lactobacilli
probiotic
vaginal fluid simulant
microbiome
recovery
url https://www.mdpi.com/2673-8007/3/4/82
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