Vaginal microbiota compositions for treating recurrent pregnancy loss
OwnerElleke Fenna BOSMA, Brynjulf MORTENSEN +4inventors
InventorsElleke Fenna BOSMA, Brynjulf MORTENSEN, Johan E.T. VAN HYLCKAMA VLIEG, Kevin DELONG, Henriette Svarre NIELSEN, Tine WRONDING
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Abstract
The invention relates to vaginal compositions for treating recurrent pregnancy loss (RPL) and therapeutic methods to do so.
Claims36
A method of treating recurrent pregnancy loss (RPL), comprising administering a therapeutically effective amount of a vaginal composition to a genitourinary tract of a subject in need thereof, wherein the subject exhibits a dysbiotic microbiota in the genitourinary tract, further wherein the vaginal composition comprises:
- (i) one, two, three or four bacterial species from the genus Lactobacillus which comprise about 80% to about 99.9% of all detectable bacterial species of the vaginal composition, optionally, wherein the bacterial species are selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri;
- (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.;
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- (iii) vaginal transudate or mucus.
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A method of producing a vaginal composition, wherein the method comprises the steps of:
- (a) processing a microbiota sample from a donor female genitourinary tract, wherein the microbiota sample comprises a vaginal mucosal sample or cervicovaginal secretion, further comprising urogenital microbes and vaginal mucosal fluid from the vaginal cavity of a healthy donor subject;
- (b) assessing the absence of one or more pathogens;
- (c) assessing viability or quantity of the urogenital microbes, and
- (d) releasing the vaginal composition comprising the microbiota sample from quarantine for use in an assisted reproductive procedure, if a predetermined level is obtained in step (b) and (c).
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Dependencies are inferred from the claim text.