Effects of Uro-Vaxom vs. placebo on the urinary tract microbiome in individuals with spinal cord injury in a randomized controlled pilot trial (Uro-Vaxom pilot)
Abstract Individuals with spinal cord injury/disease (SCI/D) have a high incidence of urinary tract infections (UTI). This randomized controlled pilot trial investigated the effect of an immunomodulator (Uro-Vaxom) versus a placebo on the urinary tract microbiome of individuals with SCI/D to inform...
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Nature Portfolio
2025-04-01
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| Series: | Scientific Reports |
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| Online Access: | https://doi.org/10.1038/s41598-025-96939-y |
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| author | Ezra Valido Alessandro Bertolo Jens Wöllner Jürgen Pannek Jörg Krebs Jivko Stoyanov |
| author_facet | Ezra Valido Alessandro Bertolo Jens Wöllner Jürgen Pannek Jörg Krebs Jivko Stoyanov |
| author_sort | Ezra Valido |
| collection | DOAJ |
| description | Abstract Individuals with spinal cord injury/disease (SCI/D) have a high incidence of urinary tract infections (UTI). This randomized controlled pilot trial investigated the effect of an immunomodulator (Uro-Vaxom) versus a placebo on the urinary tract microbiome of individuals with SCI/D to inform the design of a larger trial. Twenty participants with SCI/D undergoing primary rehabilitation were randomized to receive either Uro-Vaxom or a placebo for three months (ClinicalTrials.gov NCT04049994 08/08/2019). Urine was collected at baseline, immediately post-treatment, and three months post-treatment. DNA was extracted and sequenced using full-length 16 S rRNA using Oxford Nanopore technology. Internal controls were added for absolute abundance estimation. There were 10 participants in Uro-Vaxom and 10 in placebo analyzed. The prevalence of Escherichia coli was lower in the Uro-Vaxom group (2/10) compared to the placebo group (5/10) post-treatment, although this difference was not statistically significant. Significant alpha and beta diversity differences were associated with the microbial load, sex, and voiding method. Uro-Vaxom showed potential in reducing E. coli prevalence during the treatment period, but this result requires validation in a larger trial. Future trials should consider the baseline microbial load and optimal timing of intervention to ensure that the observed effects are attributable to immunomodulation. |
| format | Article |
| id | doaj-art-d43cf4242d304f5186aaee7057cefca2 |
| institution | OA Journals |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Nature Portfolio |
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| series | Scientific Reports |
| spelling | doaj-art-d43cf4242d304f5186aaee7057cefca22025-08-20T02:24:29ZengNature PortfolioScientific Reports2045-23222025-04-0115111010.1038/s41598-025-96939-yEffects of Uro-Vaxom vs. placebo on the urinary tract microbiome in individuals with spinal cord injury in a randomized controlled pilot trial (Uro-Vaxom pilot)Ezra Valido0Alessandro Bertolo1Jens Wöllner2Jürgen Pannek3Jörg Krebs4Jivko Stoyanov5SCI Population Biobanking and Translational Research, Swiss Paraplegic ResearchSCI Population Biobanking and Translational Research, Swiss Paraplegic ResearchDepartment of Neuro-Urology, Swiss Paraplegic CenterDepartment of Neuro-Urology, Swiss Paraplegic CenterNeuro-Urology, Swiss Paraplegic ResearchSCI Population Biobanking and Translational Research, Swiss Paraplegic ResearchAbstract Individuals with spinal cord injury/disease (SCI/D) have a high incidence of urinary tract infections (UTI). This randomized controlled pilot trial investigated the effect of an immunomodulator (Uro-Vaxom) versus a placebo on the urinary tract microbiome of individuals with SCI/D to inform the design of a larger trial. Twenty participants with SCI/D undergoing primary rehabilitation were randomized to receive either Uro-Vaxom or a placebo for three months (ClinicalTrials.gov NCT04049994 08/08/2019). Urine was collected at baseline, immediately post-treatment, and three months post-treatment. DNA was extracted and sequenced using full-length 16 S rRNA using Oxford Nanopore technology. Internal controls were added for absolute abundance estimation. There were 10 participants in Uro-Vaxom and 10 in placebo analyzed. The prevalence of Escherichia coli was lower in the Uro-Vaxom group (2/10) compared to the placebo group (5/10) post-treatment, although this difference was not statistically significant. Significant alpha and beta diversity differences were associated with the microbial load, sex, and voiding method. Uro-Vaxom showed potential in reducing E. coli prevalence during the treatment period, but this result requires validation in a larger trial. Future trials should consider the baseline microbial load and optimal timing of intervention to ensure that the observed effects are attributable to immunomodulation.https://doi.org/10.1038/s41598-025-96939-ySpinal cord injuryUro-VaxomFull length 16S rRNAImmunomodulationUrinary tract infections |
| spellingShingle | Ezra Valido Alessandro Bertolo Jens Wöllner Jürgen Pannek Jörg Krebs Jivko Stoyanov Effects of Uro-Vaxom vs. placebo on the urinary tract microbiome in individuals with spinal cord injury in a randomized controlled pilot trial (Uro-Vaxom pilot) Scientific Reports Spinal cord injury Uro-Vaxom Full length 16S rRNA Immunomodulation Urinary tract infections |
| title | Effects of Uro-Vaxom vs. placebo on the urinary tract microbiome in individuals with spinal cord injury in a randomized controlled pilot trial (Uro-Vaxom pilot) |
| title_full | Effects of Uro-Vaxom vs. placebo on the urinary tract microbiome in individuals with spinal cord injury in a randomized controlled pilot trial (Uro-Vaxom pilot) |
| title_fullStr | Effects of Uro-Vaxom vs. placebo on the urinary tract microbiome in individuals with spinal cord injury in a randomized controlled pilot trial (Uro-Vaxom pilot) |
| title_full_unstemmed | Effects of Uro-Vaxom vs. placebo on the urinary tract microbiome in individuals with spinal cord injury in a randomized controlled pilot trial (Uro-Vaxom pilot) |
| title_short | Effects of Uro-Vaxom vs. placebo on the urinary tract microbiome in individuals with spinal cord injury in a randomized controlled pilot trial (Uro-Vaxom pilot) |
| title_sort | effects of uro vaxom vs placebo on the urinary tract microbiome in individuals with spinal cord injury in a randomized controlled pilot trial uro vaxom pilot |
| topic | Spinal cord injury Uro-Vaxom Full length 16S rRNA Immunomodulation Urinary tract infections |
| url | https://doi.org/10.1038/s41598-025-96939-y |
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