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

NCT05090553 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-08-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

    collaborator OTHER_GOV

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Gaffree & Guinle Universitary Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2022-08-01
Completion
2022-10-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05090553 on ClinicalTrials.gov