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

Gaffree & Guinle Universitary Hospital120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

120

Conditions

Back Pain, Low Degenerative Disc Disease

Interventions

Lumbar Spinal Fusion SurgeryPROCEDURE

During surgery will be collected five disc fragments and five fragments of muscle-ligament tissue adjacent to the collected disc.

Bacterial cultureBIOLOGICAL

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 characterizationGENETIC

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * low back pain lasting longer than 3 months; * 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: * History of open lumbar spine surgery at any stage of life; * 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

Locations (1)

Hospital Universitário Gaffrée e Guinle

Rio de Janeiro, Brazil

RECRUITING

Outcomes

Primary Outcomes

Incidence of C. acnes on intervertebral disc

Incidence of C. acnes on intervertebral disc in patients with chronic low back pain and DDL.

Time frame: Up to 5 months

Central Contacts

Vinicius M da Rocha, MD

CONTACT

55 21 99700-7240 viniciusmagnodarocha@gmail.com

Data from ClinicalTrials.gov

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