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

Gaffree & Guinle Universitary Hospital

Status: Enrolling

Conditions: Degenerative Disc Disease; Back Pain, Low

Treatments: Genetic: Multiomics analysis; Biological: Bacterial culture; Procedure: Lumbar Spinal Fusion Surgery; Genetic: Phenotypic and genotypic characterization

Study type: Interventional

Funder types: Other

Identifiers

NCT05090553

VMRDocProtocol_2021

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups

surgical treatment

Active Comparator group

Description:

Lumbar Spinal Fusion Surgery

Treatment:

Procedure: Lumbar Spinal Fusion Surgery

Bacterial culture

Experimental group

Description:

Cutibacterium acnes culture in two different atmosphere: * Carbon dioxide (CO2) from 5% up to 10% * CO2 10%, H2 10% and N2 80%

Treatment:

Biological: Bacterial culture

Phenotypic and genotypic characterization

Experimental group

Description:

Mass spectrometry and (Polimerase Chain Reaction) PCR

Treatment:

Genetic: Phenotypic and genotypic characterization

Multiomics analysis

Experimental group

Description:

* Genome sequencing * Proteomics * Metabolomics

Treatment:

Genetic: Multiomics analysis