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 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.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 10 participants or records.
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