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

Primary Purpose

Back Pain, Low, Degenerative Disc Disease

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Lumbar Spinal Fusion Surgery
Bacterial culture
Phenotypic and genotypic characterization
Multiomics analysis
Sponsored by
Gaffree & Guinle Universitary Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Back Pain, Low

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Universitário Gaffrée e GuinleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

surgical treatment

Bacterial culture

Phenotypic and genotypic characterization

Multiomics analysis

Arm Description

Lumbar Spinal Fusion Surgery

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

Mass spectrometry and (Polimerase Chain Reaction) PCR

Genome sequencing Proteomics Metabolomics

Outcomes

Primary Outcome Measures

Incidence of C. acnes on intervertebral disc
Incidence of C. acnes on intervertebral disc in patients with chronic low back pain and DDL.

Secondary Outcome Measures

Full Information

First Posted
September 28, 2021
Last Updated
August 9, 2022
Sponsor
Gaffree & Guinle Universitary Hospital
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT05090553
Brief Title
Protocol for an Analytical Study With Microbiological, Phenotypic, Genotypic and Multiomics Techniques
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaffree & Guinle Universitary Hospital
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Low, Degenerative Disc Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
surgical treatment
Arm Type
Active Comparator
Arm Description
Lumbar Spinal Fusion Surgery
Arm Title
Bacterial culture
Arm Type
Experimental
Arm Description
Cutibacterium acnes culture in two different atmosphere: Carbon dioxide (CO2) from 5% up to 10% CO2 10%, H2 10% and N2 80%
Arm Title
Phenotypic and genotypic characterization
Arm Type
Experimental
Arm Description
Mass spectrometry and (Polimerase Chain Reaction) PCR
Arm Title
Multiomics analysis
Arm Type
Experimental
Arm Description
Genome sequencing Proteomics Metabolomics
Intervention Type
Procedure
Intervention Name(s)
Lumbar Spinal Fusion Surgery
Intervention Description
During surgery will be collected five disc fragments and five fragments of muscle-ligament tissue adjacent to the collected disc.
Intervention Type
Biological
Intervention Name(s)
Bacterial culture
Intervention Description
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
Intervention Type
Genetic
Intervention Name(s)
Phenotypic and genotypic characterization
Intervention Description
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.
Intervention Type
Genetic
Intervention Name(s)
Multiomics analysis
Intervention Description
Whole Genome Sequencing, proteomics and metabolomics analysis
Primary Outcome Measure Information:
Title
Incidence of C. acnes on intervertebral disc
Description
Incidence of C. acnes on intervertebral disc in patients with chronic low back pain and DDL.
Time Frame
Up to 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vinicius M da Rocha, MD
Phone
55 21 99700-7240
Email
viniciusmagnodarocha@gmail.com
Facility Information:
Facility Name
Hospital Universitário Gaffrée e Guinle
City
Rio de Janeiro
ZIP/Postal Code
20270-004
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vinicius M da Rocha, MD
Phone
55 21 99700-7240
Email
viniciusmagnodarocha@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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