NCT05090553

Protocol for an Analytical Study With Microbiological, Phenotypic, Genotypic and Multiomics Techniques

Cutibacterium Acnes Colonization on Intervertebral Discs of Patients With Low Back Pain: Protocol for an Analytical Study With Microbiological, Phenotypic, Genotypic and Multiomics Techniques

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Gaffree & Guinle Universitary Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Back Pain, Low
• Degenerative Disc Disease

Interventions

Type	Name	Description
PROCEDURE	Lumbar Spinal Fusion Surgery	During surgery will be collected five disc fragments and five fragments of muscle-ligament tissue adjacent to the collected disc.
BIOLOGICAL	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
GENETIC	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.
GENETIC	Multiomics analysis	Whole Genome Sequencing, proteomics and metabolomics analysis

Timeline

• Start date: 2021-08-01
• Primary completion: 2022-08-01
• Completion: 2022-10-01
• First posted: 2021-10-22
• Last updated: 2022-08-10

Locations

1 site across 1 country: Brazil