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

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05090553
• Other study ID #: VMRDocProtocol_2021
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: August 2022
• Source: Gaffree & Guinle Universitary Hospital
• Contact: Vinicius M da Rocha, MD
• Phone: 55 21 99700-7240
• Email: viniciusmagnodarocha[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Back Pain, Low
• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Low Back Pain

Intervention

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.
• Multiomics analysis
Whole Genome Sequencing, proteomics and metabolomics analysis

Locations

Country	Name	City	State
Brazil	Hospital Universitário Gaffrée e Guinle	Rio de Janeiro

Sponsors (3)

Lead Sponsor	Collaborator
Gaffree & Guinle Universitary Hospital	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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