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| Name | Class |
|---|---|
| Coordenação de Aperfeiçoamento de Pessoal de NÃvel Superior. | OTHER_GOV |
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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The study aims to identify metabolites present in intervertebral discs colonized by C. acnes from patients with low back pain and degenerative disc disease, correlating them with their clinical, radiological and demographic profiles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| surgical treatment | Active Comparator | Lumbar Spinal Fusion Surgery |
|
| Bacterial culture | Experimental | Cutibacterium acnes culture in two different atmosphere:
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| Phenotypic and genotypic characterization | Experimental | Mass spectrometry and (Polimerase Chain Reaction) PCR |
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| Multiomics analysis | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumbar Spinal Fusion Surgery | Procedure | During surgery will be collected five disc fragments and five fragments of muscle-ligament tissue adjacent to the collected disc. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of C. acnes on intervertebral disc | Incidence of C. acnes on intervertebral disc in patients with chronic low back pain and DDL. | Up to 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vinicius M da Rocha, MD | Contact | 55 21 99700-7240 | viniciusmagnodarocha@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitário Gaffrée e Guinle | Recruiting | Rio de Janeiro | 20270-004 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36848344 | Derived | 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. |
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Neither the patient nor the surgeons will have access to the results of microbiological cultures or molecular analysis. The radiologist who will review the exams will also be blinded to patient data and laboratory results. The researcher who will analyze the pain and function scores will also be blinded.
| Bacterial culture | Biological | 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 | Genetic | 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. |
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| Multiomics analysis | Genetic | Whole Genome Sequencing, proteomics and metabolomics analysis |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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