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dc.contributor.authorDausset, C.
dc.contributor.authorPatrier, S.
dc.contributor.authorGajer, P.
dc.date.accessioned2019-06-05T18:28:14Z
dc.date.available2019-06-05T18:28:14Z
dc.date.issued2018
dc.identifier.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-85050245206&doi=10.1007%2fs10096-018-3321-8&partnerID=40&md5=e5b8b98d6607ecc31a9ace2a3884c9a7
dc.identifier.urihttp://hdl.handle.net/10713/9407
dc.description.abstractGynophilus® (Lcr regenerans®) is a live biotherapeutic product (LBP) that contains the live biotherapeutic microorganism Lactobacillus rhamnosus Lcr35®, which is indicated to restore vaginal health. The aim of the study was to compare the safety, ease of use, and compliance of two formulations (immediate release: IR capsule and slow release: SR muco-adhesive tablets) as well as the colonization of Lcr35® in healthy women. This phase I study (Comprigel) is a parallel, randomized, 4-arm, and open-label clinical trial evaluating an IR daily capsule formulation vs. a SR tablet administered every 3, 4, or 5 days for 21 days. Self-collected vaginal swabs were used to quantify Lcr35® and characterize the composition and structure of the vaginal microbiota. Both LBPs were well-tolerated, and no severe adverse effects were reported. All groups had Lcr35® vaginal concentrations over 107 colony forming unit per milliliter of vaginal secretion on each day in the study. The new Gynophilus® slow release tablets administered either every 3, 4, or 5 days provided vaginal concentrations that were not significantly different from those of classic Gynophilus® (capsule) once-a-day regimen. The LBPs and the different regimens did not adversely influence the abundance of native Lactobacillus spp. and indeed tended to favor their growth and reduce colonization by non-Lactobacillus spp. This study illustrates that the SR muco-adhesive LBP tablet (Gynophilus® SR) administered every 3 or 4 days as a safe, well-tolerated, and efficacious alternative to a more demanding IR daily capsule and could protect women’s healthy vaginal microbiome by promoting endogenous Lactobacillus spp. Copyright 2018, The Author(s).en_US
dc.description.sponsorshipThis pilot CompriGel study was supported by BIOSE.en_US
dc.description.urihttps://dx.doi.org/10.1007/s10096-018-3321-8en_US
dc.language.isoen-USen_US
dc.publisherSpringer Verlagen_US
dc.relation.ispartofEuropean Journal of Clinical Microbiology and Infectious Diseases
dc.subjectLcr35en_US
dc.subjectLive biotherapeutic producten_US
dc.subjectMuco-adhesive tableten_US
dc.subjectSafetyen_US
dc.subjectSlow releaseen_US
dc.subjectVaginal infectionsen_US
dc.subjectVaginal microbiotaen_US
dc.titleComparative phase I randomized open-label pilot clinical trial of Gynophilus® (Lcr regenerans®) immediate release capsules versus slow release muco-adhesive tabletsen_US
dc.typeArticleen_US
dc.identifier.doi10.1007/s10096-018-3321-8
dc.identifier.pmid30032443


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