Immunomodulation for primary prevention of urinary tract infections in patients with spinal cord injury during primary rehabilitation: protocol for a randomized placebo-controlled pilot trial (UROVAXOM-pilot)
Abstract Background Urinary tract infections (UTIs) are common in individuals with neurogenic lower urinary tract dysfunction (NLUTD) following spinal cord injury (SCI). They are not only a great burden for affected individuals, but also cause considerable health costs. Furthermore, recurrent antibi...
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| Format: | Article |
| Language: | English |
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BMC
2021-10-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-021-05630-w |
| _version_ | 1818691532957417472 |
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| author | Jörg Krebs Jivko Stoyanov Jens Wöllner Ezra Valido Jürgen Pannek |
| author_facet | Jörg Krebs Jivko Stoyanov Jens Wöllner Ezra Valido Jürgen Pannek |
| author_sort | Jörg Krebs |
| collection | DOAJ |
| description | Abstract Background Urinary tract infections (UTIs) are common in individuals with neurogenic lower urinary tract dysfunction (NLUTD) following spinal cord injury (SCI). They are not only a great burden for affected individuals, but also cause considerable health costs. Furthermore, recurrent antibiotic treatments of UTIs contribute to the growing problem of bacterial resistance to antimicrobial compounds. Even though there is a multitude of different measures to prevent UTIs in individuals with NLUTD, no clear evidence exists for any of these. Oral immunomodulation with UTI-relevant Escherichia coli lysate may be a promising preventative measure with a good safety profile in individuals with NLUTD. However, currently available data are sparse. Methods This is a randomized, quasi-blinded, placebo-controlled, mono-centric pilot trial investigating the feasibility of a main trial regarding the effects of a lyophilized lysate of E. coli strains for oral application (Uro-Vaxom®, OM Pharma SA, Meyrin, Switzerland). There will be two parallel groups of 12 participants each. Individuals with acute SCI (duration SCI ≤ 56 days) from 18 to 70 years of age admitted for primary rehabilitation will be eligible. Blood and urine samples will be taken prior to intervention start, at the end of the intervention, and 3 months after intervention termination. The trial intervention will last 90 days. The participants will not be informed regarding the treatment allocation (quasi-blinded). The nursing staff will prepare the daily dose of the allocated treatment from the original packaging. The trial personnel and the biostatistician will be blinded. Feasibility (e.g., recruitment rate, patient attrition), clinical (e.g., number of symptomatic UTIs), and laboratory parameters (e.g., urinary culture, urinary proteo- and microbiome, blood cell counts) as well as adverse events will be collected. Discussion Effective and efficient measures for the prevention of UTIs in individuals with NLUTD are urgently needed. If the conclusion of this pilot is positive regarding feasibility, the effects of oral immunomodulation with a E. coli lysate will be investigated in a larger, sufficiently powered, multi-center trial. Trial registration ClinicalTrials.gov NCT04049994 . Registered on 8 August 2019 |
| first_indexed | 2024-12-17T12:43:24Z |
| format | Article |
| id | doaj.art-0cef8e722c854405a51fc99e50888166 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-17T12:43:24Z |
| publishDate | 2021-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-0cef8e722c854405a51fc99e508881662022-12-21T21:47:51ZengBMCTrials1745-62152021-10-0122111110.1186/s13063-021-05630-wImmunomodulation for primary prevention of urinary tract infections in patients with spinal cord injury during primary rehabilitation: protocol for a randomized placebo-controlled pilot trial (UROVAXOM-pilot)Jörg Krebs0Jivko Stoyanov1Jens Wöllner2Ezra Valido3Jürgen Pannek4Clinical Trial Unit, Swiss Paraplegic CentreSCI Population Biobanking & Translational Medicine Group, Swiss Paraplegic ResearchNeuro-Urology, Swiss Paraplegic CentreSCI Population Biobanking & Translational Medicine Group, Swiss Paraplegic ResearchNeuro-Urology, Swiss Paraplegic CentreAbstract Background Urinary tract infections (UTIs) are common in individuals with neurogenic lower urinary tract dysfunction (NLUTD) following spinal cord injury (SCI). They are not only a great burden for affected individuals, but also cause considerable health costs. Furthermore, recurrent antibiotic treatments of UTIs contribute to the growing problem of bacterial resistance to antimicrobial compounds. Even though there is a multitude of different measures to prevent UTIs in individuals with NLUTD, no clear evidence exists for any of these. Oral immunomodulation with UTI-relevant Escherichia coli lysate may be a promising preventative measure with a good safety profile in individuals with NLUTD. However, currently available data are sparse. Methods This is a randomized, quasi-blinded, placebo-controlled, mono-centric pilot trial investigating the feasibility of a main trial regarding the effects of a lyophilized lysate of E. coli strains for oral application (Uro-Vaxom®, OM Pharma SA, Meyrin, Switzerland). There will be two parallel groups of 12 participants each. Individuals with acute SCI (duration SCI ≤ 56 days) from 18 to 70 years of age admitted for primary rehabilitation will be eligible. Blood and urine samples will be taken prior to intervention start, at the end of the intervention, and 3 months after intervention termination. The trial intervention will last 90 days. The participants will not be informed regarding the treatment allocation (quasi-blinded). The nursing staff will prepare the daily dose of the allocated treatment from the original packaging. The trial personnel and the biostatistician will be blinded. Feasibility (e.g., recruitment rate, patient attrition), clinical (e.g., number of symptomatic UTIs), and laboratory parameters (e.g., urinary culture, urinary proteo- and microbiome, blood cell counts) as well as adverse events will be collected. Discussion Effective and efficient measures for the prevention of UTIs in individuals with NLUTD are urgently needed. If the conclusion of this pilot is positive regarding feasibility, the effects of oral immunomodulation with a E. coli lysate will be investigated in a larger, sufficiently powered, multi-center trial. Trial registration ClinicalTrials.gov NCT04049994 . Registered on 8 August 2019https://doi.org/10.1186/s13063-021-05630-wSpinal cord injuryNeurogenic lower urinary tract dysfunctionUrinary tract infectionEscherichia coliUro-Vaxom®Immunotherapy |
| spellingShingle | Jörg Krebs Jivko Stoyanov Jens Wöllner Ezra Valido Jürgen Pannek Immunomodulation for primary prevention of urinary tract infections in patients with spinal cord injury during primary rehabilitation: protocol for a randomized placebo-controlled pilot trial (UROVAXOM-pilot) Trials Spinal cord injury Neurogenic lower urinary tract dysfunction Urinary tract infection Escherichia coli Uro-Vaxom® Immunotherapy |
| title | Immunomodulation for primary prevention of urinary tract infections in patients with spinal cord injury during primary rehabilitation: protocol for a randomized placebo-controlled pilot trial (UROVAXOM-pilot) |
| title_full | Immunomodulation for primary prevention of urinary tract infections in patients with spinal cord injury during primary rehabilitation: protocol for a randomized placebo-controlled pilot trial (UROVAXOM-pilot) |
| title_fullStr | Immunomodulation for primary prevention of urinary tract infections in patients with spinal cord injury during primary rehabilitation: protocol for a randomized placebo-controlled pilot trial (UROVAXOM-pilot) |
| title_full_unstemmed | Immunomodulation for primary prevention of urinary tract infections in patients with spinal cord injury during primary rehabilitation: protocol for a randomized placebo-controlled pilot trial (UROVAXOM-pilot) |
| title_short | Immunomodulation for primary prevention of urinary tract infections in patients with spinal cord injury during primary rehabilitation: protocol for a randomized placebo-controlled pilot trial (UROVAXOM-pilot) |
| title_sort | immunomodulation for primary prevention of urinary tract infections in patients with spinal cord injury during primary rehabilitation protocol for a randomized placebo controlled pilot trial urovaxom pilot |
| topic | Spinal cord injury Neurogenic lower urinary tract dysfunction Urinary tract infection Escherichia coli Uro-Vaxom® Immunotherapy |
| url | https://doi.org/10.1186/s13063-021-05630-w |
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