Antibiotic-free vaginal microbiota transplantation (VMT) changes vaginal microbiota and immune profile in women with asymptomatic dysbiosis: reporting of a randomized, placebo-controlled trial
Bosma, E. F.; Mortensen, B.; DeLong, K.; Roepke, M.; Juel, H. B.; Rich, R.; Axelsen, A.; Scheeper, M.; Marvig, R.; Rasmussen, T. G.; Acosta, C.; Binne, U.; Thomsen, A. B.; Ingerslev, H.-C.; Zulfiqar, F.; Wroending, T.; Cotter, P.; O'Brien, M.; Patel, S.; Dam, S.; Nicholson, J. A.; Nielsen, H. S.; Dinan, T.; McCarthy, F.; van Hylckama Vlieg, J. E. T.; Ensign, L. M.
Show abstract
Here, we describe the first placebo-controlled trial of vaginal microbiota transplantation (VMT) in women with asymptomatic dysbiosis without the use of antibiotic pretreatment. Importantly, we also describe the implementation of a donor program and banking of donor cervicovaginal secretions (CVS) while retaining sample viability, which is crucial to allow for scale-up and confirmatory quality testing. By metagenome sequencing, we demonstrate that VMT provided a significant increase in combined Lactobacillus species in the active arm and strain-level genetic analysis confirmed Lactobacillus engraftment. Moreover, VMT was well tolerated and showed a good safety profile. Furthermore, a shift toward increased Lactobacillus was associated with a change in the expression profile of genes in the complement pathway to a more anti-inflammatory profile. Vaginal microbial and immune profile restoration using VMT may have a positive impact on a wide range of conditions in womens health.
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