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Antibiotic-free vaginal microbiota transplantation (VMT) changes vaginal microbiota and immune profile in women with asymptomatic dysbiosis – reporting of a randomized, placebo-controlled trial

medRxiv
2024
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Article Description

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 women’s health.

Bibliographic Details

Elleke F. Bosma; Brynjulf Mortensen; Kevin DeLong; Mads A. Røpke; Helene Baek Juel; Randi Rich; Amalie M. Axelsen; Marouschka J. Scheeper; Rasmus L. Marvig; Thomas Gundelund Rasmussen; Colleen Acosta; Ulrich K. Binné; Anne Bloch Thomsen; Johan E.T. van Hylckama Vlieg; Laura M. Ensign; Hans Christian Ingerslev; Fareeha Zulfiqar; Tine Wrønding; Henriette Svarre Nielsen; Paul D. Cotter; Marcus O'Brien; Shriram Patel; Sarita A. Dam; Timothy G. Dinan; Julia Albert Nicholson; Fergus P. McCarthy

Cold Spring Harbor Laboratory

Medicine

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