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

NCT05090553 | Unknown

• 1 other identifier: VMRDocProtocol_2021
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

surgical treatment

ACTIVE COMPARATOR

Lumbar Spinal Fusion Surgery

Procedure: Lumbar Spinal Fusion Surgery

Bacterial culture

EXPERIMENTAL

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

Phenotypic and genotypic characterization

EXPERIMENTAL

Mass spectrometry and (Polimerase Chain Reaction) PCR

Genetic: Phenotypic and genotypic characterization

Multiomics analysis

EXPERIMENTAL

* Genome sequencing * Proteomics * Metabolomics

Genetic: Multiomics analysis

Interventions

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.

surgical treatment

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

Bacterial culture

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.

Phenotypic and genotypic characterization

Multiomics analysis GENETIC

Whole Genome Sequencing, proteomics and metabolomics analysis

Multiomics analysis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• low back pain lasting longer than 3 months;
• 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

You may not qualify if:

• 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;
• use of antibiotics in the 2 months prior to the surgical procedure

Sponsors & Collaborators

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

Study Sites (1)

Hospital Universitário Gaffrée e Guinle

Rio de Janeiro, 20270-004, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 36848344 DERIVED

MeSH Terms

Conditions

Low Back Pain; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Vinicius M da Rocha, MD

CONTACT

55 21 99700-7240; viniciusmagnodarocha@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 22, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: October 1, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

BR (1)