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

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 Overview

• Status: Recruiting
• Conditions: Degenerative Disc Disease; Back Pain, Low
• Intervention / Treatment: Procedure: Lumbar Spinal Fusion Surgery; Biological: Bacterial culture; Genetic: Phenotypic and genotypic characterization; Genetic: Multiomics analysis

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vinicius M da Rocha, MD; Phone Number: 55 21 99700-7240; Email: viniciusmagnodarocha@gmail.com

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 20270-004
    • Recruiting
    • Hospital Universitario Gaffree e Guinle
    • Contact: Vinicius M da Rocha, MD; Phone Number: 55 21 99700-7240; Email: viniciusmagnodarocha@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: surgical treatment; Lumbar Spinal Fusion Surgery	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.
Experimental: Bacterial culture; Cutibacterium acnes culture in two different atmosphere: Carbon dioxide (CO2) from 5% up to 10%; CO2 10%, H2 10% and N2 80%	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
Experimental: Phenotypic and genotypic characterization; Mass spectrometry and (Polimerase Chain Reaction) PCR	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.
Experimental: Multiomics analysis; Genome sequencing; Proteomics; Metabolomics	Genetic: Multiomics analysis; Whole Genome Sequencing, proteomics and metabolomics analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Gaffree & Guinle Universitary Hospital
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Conselho Nacional de Desenvolvimento Científico e Tecnológico

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): August 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Back Pain; Low Back Pain; Intervertebral Disc Degeneration
• Other Study ID Numbers: VMRDocProtocol_2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No