Evidence map›Paper›PMID 40229352›Full record

Trial reportScientific reports2025

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).

Ezra Valido, Alessandro Bertolo, Jens Wöllner, Jürgen Pannek, Jörg Krebs, Jivko Stoyanov

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04049994 (Immunomodulation Therapy for Primary Prevention of Urinary Tract Infections in Patients With Spinal Cord Injury During First Rehabilitation), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04049994 phase4completednot on this map

Immunomodulation Therapy for Primary Prevention of Urinary Tract Infections in Patients With Spinal Cord Injury During First Rehabilitation: a Randomized Controlled Pilot Study

TypeinterventionalSponsorSwiss Paraplegic Research, NottwilRan2020 to 2023Enrolled24ConditionsSpinal Cord Injuries, Urinary Tract InfectionsArmsUro-Vaxom, Placebo oral tablet
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Ezra ValidoSCI Population Biobanking and Translational Research, Swiss Paraplegic Research, Guido A. Zäch Str., Nottwil, Switzerland. ezra.valido@paraplegie.ch.
Alessandro BertoloSCI Population Biobanking and Translational Research, Swiss Paraplegic Research, Guido A. Zäch Str., Nottwil, Switzerland.
Jens WöllnerDepartment of Neuro-Urology, Swiss Paraplegic Center, Guido A. Zäch Str., Nottwil, Switzerland.
Jürgen PannekDepartment of Neuro-Urology, Swiss Paraplegic Center, Guido A. Zäch Str., Nottwil, Switzerland.
Jörg Krebs *Neuro-Urology, Swiss Paraplegic Research, Nottwil, Luzern, Switzerland.
Jivko Stoyanov *SCI Population Biobanking and Translational Research, Swiss Paraplegic Research, Guido A. Zäch Str., Nottwil, Switzerland.

Funding

European Union's Horizon 2020 research and innovation program under the Marie Skłodowska-Curie grant agreement 801076
6 · The paper itself

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.

Indexed as

MicrobiotaSpinal Cord InjuriesUrinary TractUrinary Tract InfectionsAdultEscherichia coliFemaleHumansMaleMiddle AgedPilot ProjectsRNA, Ribosomal, 16SRNA, Ribosomal, 16SFull length 16S rRNAImmunomodulationSpinal cord injuryUrinary tract infectionsUro-Vaxom

Identifiers

PMID40229352
PMCPMC11997090

What Socratic holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.