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

Not Applicable

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

• Registration Number: NCT05090553
• Lead Sponsor: Gaffree & Guinle Universitary Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2021-09-28
• Study First Submitted QC: 2021-10-11
• Study First Posted: 2021-10-22
• Status Verified: 2022-08
• Primary Completion: 2022-08-01
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-10
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Bacterial culture	Bacterial culture	Cutibacterium acnes culture in two different atmosphere: * Carbon dioxide (CO2) from 5% up to 10% * CO2 10%, H2 10% and N2 80%
Multiomics analysis	Multiomics analysis	* Genome sequencing * Proteomics * Metabolomics
surgical treatment	Lumbar Spinal Fusion Surgery	Lumbar Spinal Fusion Surgery
Phenotypic and genotypic characterization	Phenotypic and genotypic characterization	Mass spectrometry and (Polimerase Chain Reaction) PCR

Primary Outcome Measures

Name	Time	Method
Incidence of C. acnes on intervertebral disc	Up to 5 months	Incidence of C. acnes on intervertebral disc in patients with chronic low back pain and DDL.

Trial Locations

Locations (1)

Hospital Universitário Gaffrée e Guinle; 🇧🇷 Rio de Janeiro, Brazil