Protocol for an Analytical Study With Microbiological, Phenotypic, Genotypic and Multiomics Techniques
NCT ID: NCT05090553
Last Updated: 2022-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2021-08-01
2022-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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surgical treatment
Lumbar Spinal Fusion Surgery
Lumbar Spinal Fusion Surgery
During surgery will be collected five disc fragments and five fragments of muscle-ligament tissue adjacent to the collected disc.
Bacterial culture
Cutibacterium acnes culture in two different atmosphere:
* Carbon dioxide (CO2) from 5% up to 10%
* CO2 10%, H2 10% and N2 80%
Bacterial culture
Samples will be seeded on blood agar and anaerobic blood agar plates. After sowing in solid media, the swab will be inoculated in thioglycolate medium, where it will remain for 14 days
Phenotypic and genotypic characterization
Mass spectrometry and (Polimerase Chain Reaction) PCR
Phenotypic and genotypic characterization
The phenotypic identification of the species will be carried out through mass spectrometry, with the MALDI-TOF equipment.
PCR analyzes performed in two phases, the first to confirm the presence of bacteria (target and non-target) using primers capable of amplifying eubacteria ribosomal deoxyribonucleic acid (rDNA) 16s and the second directed to confirm C. acnes through specific rDNA 16s primers.
Multiomics analysis
* Genome sequencing
* Proteomics
* Metabolomics
Multiomics analysis
Whole Genome Sequencing, proteomics and metabolomics analysis
Interventions
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Lumbar Spinal Fusion Surgery
During surgery will be collected five disc fragments and five fragments of muscle-ligament tissue adjacent to the collected disc.
Bacterial culture
Samples will be seeded on blood agar and anaerobic blood agar plates. After sowing in solid media, the swab will be inoculated in thioglycolate medium, where it will remain for 14 days
Phenotypic and genotypic characterization
The phenotypic identification of the species will be carried out through mass spectrometry, with the MALDI-TOF equipment.
PCR analyzes performed in two phases, the first to confirm the presence of bacteria (target and non-target) using primers capable of amplifying eubacteria ribosomal deoxyribonucleic acid (rDNA) 16s and the second directed to confirm C. acnes through specific rDNA 16s primers.
Multiomics analysis
Whole Genome Sequencing, proteomics and metabolomics analysis
Eligibility Criteria
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Inclusion Criteria
* MRI findings of degenerative lumbar discopathy (DDL) performed less than 6 months after inclusion in the study;
* indication for open surgical treatment, with isolated microdiscectomy or associated with lumbar arthrodesis;
* failure of conservative treatment for at least 6 weeks and/or progressive neurological deficit
Exclusion Criteria
* presence of chemotherapy or pulse therapy with corticoids;
* patients with immune deficiency;
* patients undergoing previous intradiscal therapies (nucleotomy or discography);
* patients undergoing previous endoscopic surgery;
* patients with a history of previous spinal infection treated with antibiotics in the 6 months prior to inclusion in the study;
* use of antibiotics in the 2 months prior to the surgical procedure
18 Years
65 Years
ALL
No
Sponsors
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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
OTHER_GOV
Conselho Nacional de Desenvolvimento Científico e Tecnológico
OTHER_GOV
Gaffree & Guinle Universitary Hospital
OTHER
Responsible Party
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Vinicius Magno da Rocha
Clinical Professor
Locations
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Hospital Universitário Gaffrée e Guinle
Rio de Janeiro, , Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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Magno da Rocha V, Lima COGX, Ferreira EO, de Farias GC, Nogueira FCS, Martha Antunes LC, Cassiano KM, Fiorelli RKA. Colonization of intervertebral discs by Cutibacterium acnes in patients with low back pain: Protocol for an analytical study with microbiological, phenotypic, genotypic, and multiomic techniques. PLoS One. 2023 Feb 27;18(2):e0271773. doi: 10.1371/journal.pone.0271773. eCollection 2023.
Other Identifiers
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VMRDocProtocol_2021
Identifier Type: -
Identifier Source: org_study_id
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